Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients

• Sponsor: Fred Hutchinson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01929408
• Collaborator: Patient-Centered Outcomes Research Institute (Other), American Cancer Society, Inc. (Other)
• Enrollment: 703
• Locations: 12
• Actual Duration (Months): 64.5
• Patients Per Site: 58.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Detailed Description

This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients. Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL). Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status. Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 703 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study
• Actual Study Start Date: Jul 19, 2013
• Actual Primary Completion Date: Dec 4, 2018
• Actual Study Completion Date: Dec 4, 2018

Outcome Measures

Primary Outcome Measures

1. Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) [1 year after starting induction]

   Percentage analyzed participants receiving HCT

Secondary Outcome Measures

1. Percentage Analyzed Participants Without HCT and Deceased [1 year after starting induction]

   Percentage analyzed participants without HCT and Deceased

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who:

• Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy

• Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician

• Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed

• Patients of 18 years of age or older, and are being treated by the adult AML service.

• Able to speak and read English.

• Willing and able to provide informed consent.

Exclusion Criteria

• Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service.

• Patients older than 80 years

• Patients with <6 months projected survival due to active second malignancy or other medical problem.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Cancer Institute	Stanford	California	United States	94305
2	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
3	University of Maryland	Baltimore	Maryland	United States	21201
4	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
5	The John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
6	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
7	Duke University	Durham	North Carolina	United States	27710
8	Cleveland Clinic	Cleveland	Ohio	United States	44195
9	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
10	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
11	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
12	SCCA Network Clinics	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Fred Hutchinson Cancer Center
• Patient-Centered Outcomes Research Institute
• American Cancer Society, Inc.

Investigators

• Principal Investigator: Mohamed Sorror, MD, MSc, Associate Member, Fred Hutch; Associate Professor of Medicine, UW

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 2, 2018

More Information

Publications

None provided.

• Responsible Party: Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT01929408
• Other Study ID Numbers: 2368.00; RSG-13-084-01-CPHPS
• First Posted: Aug 28, 2013
• Last Update Posted: Nov 15, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes

Study Results

Participant Flow

Arm/Group Title	Acute Myeloid Leukemia (AML) & Myelodysplastic Syndrome (MDS)
Arm/Group Description	All patients starting induction therapy for newly diagnosed AML or advanced MDS and followed over time
Period Title: Overall Study
STARTED	703
COMPLETED	695
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	All patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
Overall Participants	703
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	436 62%
>=65 years	267 38%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	304 43.2%
Male	399 56.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 3.8%
Not Hispanic or Latino	662 94.2%
Unknown or Not Reported	14 2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	13 1.8%
Asian	23 3.3%
Native Hawaiian or Other Pacific Islander	9 1.3%
Black or African American	41 5.8%
White	608 86.5%
More than one race	3 0.4%
Unknown or Not Reported	6 0.9%
Region of Enrollment (participants) [Number]
United States	703 100%

Outcome Measures

1. Primary Outcome

Title	Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
Description	Percentage analyzed participants receiving HCT
Time Frame	1 year after starting induction

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description	All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
Measure Participants	695
Number [% participants]	44.7 6.4%

2. Secondary Outcome

Title	Percentage Analyzed Participants Without HCT and Deceased
Description	Percentage analyzed participants without HCT and Deceased
Time Frame	1 year after starting induction

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description	All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
Measure Participants	695
Number [% participants]	32.7 4.7%

Adverse Events

Time Frame	1 year after starting induction
Adverse Event Reporting Description	Adverse events did not occur as a direct result of this observational study
Arm/Group Title	All Patients
Arm/Group Description	All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
All Cause Mortality
	All Patients
	Affected / at Risk (%)	# Events
Total	309/695 (44.5%)
Serious Adverse Events
	All Patients
	Affected / at Risk (%)	# Events
Total	0/695 (0%)
Other (Not Including Serious) Adverse Events
	All Patients
	Affected / at Risk (%)	# Events
Total	0/695 (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.