Preservation of Ovarian Function After Hematopoietic Cell Transplant

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01343368
• Collaborator: Minnesota Medical Foundation (Other)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease; Acute Myeloid Leukemia; Myeloproliferative Disorders	Drug: Leuprolide; Biological: hematopoietic cell transplant; Biological: reduced intensity allogeneic HCT	Phase 2

Detailed Description

This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women.

The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.

The secondary objectives are

• to determine how effective GnRH agonists are at suppressing menses during

• to determine the incidence and timing of resumption of menstrual cycles after HCT

• to determine the incidence and timing of resumption of normal FSH and LH levels after HCT

• to determine the incidence of normal AMH levels after HCT

• to determine the effect of GnRH agonists on immune reconstitution after HCT

• to assess the safety and tolerability of GnRH agonists in the context of HCT

A total of 47 patients will be accrued in this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional - Received Leuprolide Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.	Drug: Leuprolide; Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days; Other Names: Lupron Depot-3(R) Leuprolide acetate ; Biological: hematopoietic cell transplant; Conventional bone marrow transplant regimen.; Other Names: HCT
Active Comparator: Observational Arm Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.	Biological: reduced intensity allogeneic HCT; A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.; Other Names: RIC

Outcome Measures

Primary Outcome Measures

1. Comparison of Number of Patients With Ovarian Failure [Through Day 180 Post Transplant]

   Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.

Secondary Outcome Measures

1. Comparison of Number of Patients Who Stopped Menstrual Bleeding [From Baseline Through Day 365]

   Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant

2. Comparison of Follicle Stimulating Hormone (FSH) Levels [Baseline]

   Comparison of treatment arms; interventional versus observational average FSH levels.

3. Comparison of Follicle Stimulating Hormone (FSH) Levels [Day 100]

   Comparison of treatment arms; interventional versus observational average FSH levels.

4. Comparison of Follicle Stimulating Hormone (FSH) Levels [Day 180]

   Comparison of treatment arms; interventional versus observational average FSH levels.

5. Comparison of Follicle Stimulating Hormone (FSH) Levels [1 year]

   Comparison of treatment arms; interventional versus observational average FSH levels.

6. Comparison of Follicle Stimulating Hormone (FSH) Levels [2 years]

   Comparison of treatment arms; interventional versus observational average FSH levels.

7. Comparison of Number of Patients Who Resumed Menstrual Cycles [Day 365 Post Transplant]

   Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant

8. Comparison of Lutineizing Hormone (LH) Levels [Baseline]

   Comparison of treatment arms; interventional versus observational average LH levels during study.

9. Comparison of Luteinizing Hormone (LH) Levels [Day 100]

   Comparison of treatment arms; interventional versus observational average LH levels during study.

10. Comparison of Luteinizing Hormone (LH) Levels [Day 180]

    Comparison of treatment arms; interventional versus observational average LH levels during study.

11. Comparison of Luteinizing Hormone (LH) Levels [1 year]

    Comparison of treatment arms; interventional versus observational average LH levels during study.

12. Comparison of Leuprolide Hormone (LH) Levels [2 years]

    Comparison of treatment arms; interventional versus observational average LH levels during study.

13. Comparison of Antimullerian Hormone (AMH) Levels After Transplant [Day Prior to Transplant]

    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

14. Comparison of Antimullerian Hormone (AMH) Levels After Transplant [Day 180 after Transplant]

    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Interventional Arm:

• Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT)

• Post-menarchal female < or = 50 years of age

• Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty

• Those women who have an FSH > 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.

• Observational Arm:

• Eligible for reduced intensity allogeneic HCT

• Post-menarchal female ≤ 50 years of age

• Normal AMH level and/or FSH/LH for age/stage of puberty

• Those women who an FSH >40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.

Exclusion Criteria:

• All Arms:

• History of ovarian cancer

• Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact.

• Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• Minnesota Medical Foundation

Investigators

• Principal Investigator: Angela Smith, M.D., Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT01343368
• Other Study ID Numbers: 2010LS053; 012M93555
• First Posted: Apr 28, 2011
• Last Update Posted: Dec 5, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Masonic Cancer Center, University of Minnesota: Post-menarchal
• Additional relevant MeSH terms: Multiple Myeloma; Hodgkin Disease; Myeloproliferative Disorders; Leuprolide

Study Results

Participant Flow

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Period Title: Overall Study
STARTED	9	10
COMPLETED	7	10
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm	Total
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.	Total of all reporting groups
Overall Participants	7	10	17
Age (Count of Participants)
<=18 years	2 28.6%	6 60%	8 47.1%
Between 18 and 65 years	5 71.4%	4 40%	9 52.9%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 100%	10 100%	17 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Comparison of Number of Patients With Ovarian Failure
Description	Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.
Time Frame	Through Day 180 Post Transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	7	10
Count of Participants [Participants]	3 42.9%	1 10%

2. Secondary Outcome

Title	Comparison of Number of Patients Who Stopped Menstrual Bleeding
Description	Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant
Time Frame	From Baseline Through Day 365

Outcome Measure Data

Analysis Population Description

Five patients on the Interventional arm and 10 patients on the Observational arm were lost to follow-up by Day 365.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	2	0
Count of Participants [Participants]	2 28.6%	0 0%

3. Secondary Outcome

Title	Comparison of Follicle Stimulating Hormone (FSH) Levels
Description	Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	7	6
Mean (Standard Deviation) [IU/L]	9.3 (8.0)	4.4 (1.7)

4. Secondary Outcome

Title	Comparison of Follicle Stimulating Hormone (FSH) Levels
Description	Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame	Day 100

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	6	3
Mean (Standard Deviation) [IU/L]	18.4 (19.5)	9.1 (12.7)

5. Secondary Outcome

Title	Comparison of Follicle Stimulating Hormone (FSH) Levels
Description	Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame	Day 180

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	6	3
Mean (Standard Deviation) [IU/L]	47.0 (40.1)	4.7 (4.7)

6. Secondary Outcome

Title	Comparison of Follicle Stimulating Hormone (FSH) Levels
Description	Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	4	2
Mean (Standard Deviation) [IU/L]	61.5 (97.6)	48.8 (84.5)

7. Secondary Outcome

Title	Comparison of Follicle Stimulating Hormone (FSH) Levels
Description	Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	0	2
Mean (Standard Deviation) [IU/L]	7.1 (4.6)

8. Secondary Outcome

Title	Comparison of Number of Patients Who Resumed Menstrual Cycles
Description	Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
Time Frame	Day 365 Post Transplant

Outcome Measure Data

Analysis Population Description

Only 6 of the 10 patients that started on the Observational Arm were evaluable. The 2 patients were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	7	6
Count of Participants [Participants]	2 28.6%	4 40%

9. Secondary Outcome

Title	Comparison of Lutineizing Hormone (LH) Levels
Description	Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	7	6
Mean (Standard Deviation) [IU/L]	19.8 (30.2)	6.8 (7.6)

10. Secondary Outcome

Title	Comparison of Luteinizing Hormone (LH) Levels
Description	Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame	Day 100

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	6	3
Mean (Standard Deviation) [IU/L]	2.4 (2.7)	6.4 (7.7)

11. Secondary Outcome

Title	Comparison of Luteinizing Hormone (LH) Levels
Description	Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame	Day 180

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	6	3
Mean (Standard Deviation) [IU/L]	31.1 (32.0)	4.3 (3.0)

12. Secondary Outcome

Title	Comparison of Luteinizing Hormone (LH) Levels
Description	Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	4	2
Mean (Standard Deviation) [IU/L]	31.9 (36.1)	27.8 (41.6)

13. Secondary Outcome

Title	Comparison of Leuprolide Hormone (LH) Levels
Description	Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	0	2
Mean (Standard Deviation) [IU/L]	5.6 (4.3)

14. Secondary Outcome

Title	Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Description	Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Time Frame	Day Prior to Transplant

Outcome Measure Data

Analysis Population Description

Six patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	7	4
Mean (Standard Deviation) [ng/ml]	0.6 (0.9)	6.4 (7.7)

15. Secondary Outcome

Title	Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Description	Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Time Frame	Day 180 after Transplant

Outcome Measure Data

Analysis Population Description

Four patients on the Observational and 10 patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.

Arm/Group Title	Interventional - Received Leuprolide	Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.	Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
Measure Participants	3	0
Mean (Standard Deviation) [ng/ml]	0.08 (0)

Adverse Events

Arm/Group Title	Interventional - Received Leuprolide		Observational Arm
Arm/Group Description	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.		Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
All Cause Mortality
	Interventional - Received Leuprolide		Observational Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Interventional - Received Leuprolide		Observational Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Interventional - Received Leuprolide		Observational Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		0/10 (0%)
Psychiatric disorders
Mood Liability	3/7 (42.9%)		0/10 (0%)
Vascular disorders
Hot Flashes	3/7 (42.9%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.