Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00899847
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 67
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Transplantation, Homologous; Transplantation, Autologous; Multiple Myeloma; Blood and Marrow Transplant (BMT)	Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation; Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation; Drug: Filgrastim; Drug: Cyclophosphamide; Drug: Melphalan; Drug: Cyclosporine; Radiation: Total lymphoid irradiation; Biological: Rabbit anti-thymocyte globulin; Drug: Mycophenolate Mofetil 250mg; Drug: Solumedrol; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Hydrocortisone	Phase 2

Detailed Description

Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Autologous-Allogeneic Peripheral Blood Stem Cell Transplant Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.

Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation; Auto-PBSC ≥ 2 to 3 x 10e6 CD34+ cells/kg are intravenously (IV) infused as part of the combination stem cell therapy. and allogeneic stem cells are administered intravenous (IV) infusion to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective; Other Names: auto-PBPC Autologous peripheral blood progenitor cells (auto-PBPC) transplantation ; Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation; Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.; Other Names: allo-PBSC Allogeneic peripheral blood progenitor cells (allo-PBPC) transplantation ; Drug: Filgrastim; Filgrastim is administered subcutaneously (SC) at 10 µg/kg/day for auto-PBSC mobilization starting day 2 of mobilization until the last day of apheresis. Filgrastim is administered SC at 5 µg/kg/day from Day 6 after auto-PBSC infusion to hematologic recovery. Filgrastim is administered SC at 16 µg/kg/day for donor allo-PBSC mobilization at from Day - 4 to Day 0, prior to allo-PBSC collection.; Other Names: Neupogen Granulocyte colony-stimulating factor (G-CSF) r-metHuG-CSF ; Drug: Cyclophosphamide; Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.; Other Names: Ciclofosfamida Ciclofosfamide Claphene CP monohydrate (CPM) CSP ; Drug: Melphalan; Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.; Other Names: L-Sarcolysin L-phenylalanine mustard (L-PAM) L-Sarcolysin phenylalanine mustard L-sarcolysine ; Drug: Cyclosporine; Cyclosporine is administered by mouth (PO) for allo-PBSC graft vs host disease (GvHD) prophylaxis at 5 mg/kg from Day -3 through Bay +56. Tacrolimus may substituted.; Other Names: Cyclosporin Cyclosporin A Ciclosporin CSP ; Radiation: Total lymphoid irradiation; Total lymphoid irradiation is administered at 80 centigrey (cGy) on Day -11 to -7; and Day -4 to -2 before alllo-PBSC infusion. TLI is also administered at 80 centigrey (cGy) x 2 on Day -1 before alllo-PBSC infusion.; Other Names: TLI ; Biological: Rabbit anti-thymocyte globulin; ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.; Other Names: Thymoglobulin ATG ; Drug: Mycophenolate Mofetil 250mg; MMF is administered at 15 mg/kg 3x/day by mouth (PO) after allo-PBSC through Day 40, followed by 10% dose reduction weekly (dose taper) through day 96, and adjusted if there is evidence of MMF-related GI toxicity or excessive myelosuppression; Other Names: CellCept MMF ; Drug: Solumedrol; Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion; Other Names: Solumedin Soludecadron ; Drug: Diphenhydramine; Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.; Other Names: Benadryl ; Drug: Acetaminophen; Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.; Other Names: Tylenol ; Drug: Hydrocortisone; Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions.

Outcome Measures

Primary Outcome Measures

1. Incidence of Graft Versus Host Disease (GvHD) [2 years after the last participant is enrolled.]

   To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting

Secondary Outcome Measures

1. Median Time to Engraftment After Auto-PBSC Transplant [1 month]

   Engraftment is assessed as: Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia Platelet engraftment is > 20 x 10⁹/L after cytopenia

2. Median Time to Engraftment After Allo-PBSC Transplant [1 month]

   Engraftment is assessed as: Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia Platelet engraftment is > 20 x 10⁹/L after cytopenia

3. Overall Response Rate (ORR) [1 year]

   Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)

4. Complete Response Rate (CRR) [1 year]

   Complete response rate (CRR) was assessed as all of: Negative immunoflixation on the serum and urine Disappearance of any soft tissue plasmacytomas < 5% plasma cells in bone marrow

5. Partial Response Rate (PRR) [1 year]

   Partial response rate (PRR) was assessed as > 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma.

6. Event-free Survival (EFS) [2 years after the last participant is enrolled]

   To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)

7. Overall Survival (OS) [2 years after the last participant is enrolled]

   To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

PARTICIPANT INCLUSION CRITERIA

• Stage II-III multiple myeloma or have progression after initial treatment of Stage I disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included.

• Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at Stanford University Medical Center.

• 18 to ≤ 75 years of age

• Karnofsky Performance Status > 70%.

• Corrected Carbon monoxide diffusing capacity (Dlco) > 60%

• Left ventricle ejection fraction (LVEF) > 50%.

• Alanine aminotransferase (ALT) ≤ 2 x normal

• Aspartate aminotransferase (AST) ≤ 2 x normal

• Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease.

• Estimated creatinine clearance > 50 mL/min.

• Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor with one antigen/allele mismatch in (HLA-A, B, C or DRB1).

• Signed informed consent.

DONOR INCLUSION CRITERIA

• At least 17 years of age

• HIV-seronegative

• Must be capable of giving signed, informed consent

• No contraindication to the administration of filgrastim

• Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate

PARTICIPANT EXCLUSION CRITERIA

• Prior allogeneic hematopoietic cell transplantation

• Uncontrolled active infection

• Uncontrolled congestive heart failure or angina

• HIV-positive

• Pregnant or nursing

DONOR EXCLUSION CRITERIA

• Serious medical or psychological illness

• Pregnant or lactating

• Prior malignancies within the last 5 years except for non-melanoma skin cancers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Wen-Kai Weng, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wen-Kai Weng, Assistant Professor of Medicine (Blood and Marrow Transplantation), Stanford University
• ClinicalTrials.gov Identifier: NCT00899847
• Other Study ID Numbers: IRB-15772; SU-04142009-2259; BMT201
• First Posted: May 12, 2009
• Last Update Posted: Oct 20, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Acetaminophen; Diphenhydramine; Promethazine; Cyclosporine; Mycophenolic Acid; Hydrocortisone; Methylprednisolone Hemisuccinate; Cyclophosphamide; Melphalan; Mechlorethamine; Cyclosporins; Thymoglobulin; Antilymphocyte Serum; Lenograstim

Study Results

Participant Flow

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Period Title: Overall Study
STARTED	9
COMPLETED	7
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	54
Sex: Female, Male (Count of Participants)
Female	2 22.2%
Male	7 77.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 11.1%
Not Hispanic or Latino	8 88.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	9 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Incidence of Graft Versus Host Disease (GvHD)
Description	To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting
Time Frame	2 years after the last participant is enrolled.

Outcome Measure Data

Analysis Population Description

Due to the significance of the allo-PBSC transplant as a component to the treatment plan, participants who did not receive allo-PBSC are not included.

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
Measure Participants	7
Count of Participants [Participants]	1 11.1%

2. Secondary Outcome

Title	Median Time to Engraftment After Auto-PBSC Transplant
Description	Engraftment is assessed as: Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia Platelet engraftment is > 20 x 10⁹/L after cytopenia
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Includes all study participants

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Measure Participants	9
Neutrophil Engraftment	11
Platelet Engraftment	15

3. Secondary Outcome

Title	Median Time to Engraftment After Allo-PBSC Transplant
Description	Engraftment is assessed as: Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia Platelet engraftment is > 20 x 10⁹/L after cytopenia
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC.

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Measure Participants	2
Neutrophil Engraftment	24
Platelet Engraftment	10

4. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Includes all study participants

Arm/Group Title	Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
Arm/Group Description	Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Measure Participants	9
Count of Participants [Participants]	7 77.8%

5. Secondary Outcome

Title	Complete Response Rate (CRR)
Description	Complete response rate (CRR) was assessed as all of: Negative immunoflixation on the serum and urine Disappearance of any soft tissue plasmacytomas < 5% plasma cells in bone marrow
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Includes all study participants

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Measure Participants	9
Count of Participants [Participants]	3 33.3%

6. Secondary Outcome

Title	Partial Response Rate (PRR)
Description	Partial response rate (PRR) was assessed as > 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Includes all study participants

Arm/Group Title	Autologous-Allogeneic Peripheral Blood Stem Cell Transplant
Arm/Group Description	Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
Measure Participants	9
Count of Participants [Participants]	4 44.4%

7. Secondary Outcome

Title	Event-free Survival (EFS)
Description	To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)
Time Frame	2 years after the last participant is enrolled

Outcome Measure Data

Analysis Population Description

Includes all study participants

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
Measure Participants	9
Number (95% Confidence Interval) [percentage of participants]	44 488.9%

8. Secondary Outcome

Title	Overall Survival (OS)
Description	To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)
Time Frame	2 years after the last participant is enrolled

Outcome Measure Data

Analysis Population Description

Includes all study participants

Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
Measure Participants	9
Number (95% Confidence Interval) [percentage of participants]	67 744.4%

Adverse Events

Time Frame	2 years
Arm/Group Title	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
Arm/Group Description	A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
All Cause Mortality
	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)
Vascular disorders
Pulmonary Embolism	1/9 (11.1%)	1
Deep Vein Thrombosis	1/9 (11.1%)	1
Other (Not Including Serious) Adverse Events
	Autologous-Allogeneic Hematopoietic Stem Cell Transplant
	Affected / at Risk (%)	# Events
Total	0/9 (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.