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Allo vs. Hypomethylating/Best Supportive Care in MDS (Blood and Marrow Transplant Clinical Trials Network #1102)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical College of Wisconsin
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02016781
First received: December 16, 2013
Last updated: January 23, 2014
Last verified: January 2014

December 16, 2013
January 23, 2014
December 2013
December 2016   (final data collection date for primary outcome measure)
Overall survival probabilities [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02016781 on ClinicalTrials.gov Archive Site
  • Leukemia-free survival (LFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • QOL measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Allo vs. Hypomethylating/Best Supportive Care in MDS (Blood and Marrow Transplant Clinical Trials Network #1102)
A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 w/Intermediate-2 & High Risk Myelodysplastic Syndrome Blood and Marrow Transplant Clinical Trials Network #1102)

This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.

Background: MDS is a clonal disorder of hematopoietic precursors and stem cells, which may evolve to a terminal phase resembling acute leukemia. A subject of clinical urgency for researchers, clinicians, patients, and health care underwriters such as Medicare, is the role of allogeneic hematopoietic cell transplantation (alloHCT) in the treatment of older patients with higher risk myelodysplastic syndromes (MDS). The use of reduced intensity conditioning (RIC) regimens has extended HCT to the care of older patients with acute myelogenous leukemia (AML) and lymphoma and a number of retrospective and phase II trials for patients with MDS now show the curative potential of RIC alloHCT in selected patients.

This protocol is designed evaluate the relative benefits of RIC alloHCT compared to non-transplant therapies focusing on overall survival. This will be done by having patients biologically assigned to the alloHCT arm or the hypomethylating therapy/best supportive care arm and following them for survival at 3 years.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Patient peripheral blood and buccal swab samples will be collected at enrollment. Peripheral blood (and bone marrow samples if available) will also be collected from patients assigned to the HCT arm who experience relapse at the time of relapse and stored to support future research studies. If available, bone marrow will be collected pre-transplant for the patients assigned to the HCT arm.

Non-Probability Sample

De novo MDS patient between the ages of 50 and 75 years with no prior history of allo HCT.

MDS
  • Procedure: Allogeneic Hematopoietic Cell Transplant
  • Procedure: Hypomethylating Therapy or Best Supportive Care
MDS
Interventions:
  • Procedure: Allogeneic Hematopoietic Cell Transplant
  • Procedure: Hypomethylating Therapy or Best Supportive Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2019
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients fulfilling the following criteria will be eligible for entry into this study:

    1. Patients with de novo MDS who have, or have previously had, Intermediate-2 or High risk disease as determined by the International Prognostic Scoring System (IPSS). Current Intermediate-2 or High risk disease is NOT a requirement.
    2. Patients must have fewer than 20% marrow blasts at the time (within 30 days) of registration and consent.
    3. Patients may have received prior therapy for the treatment of MDS, including but not limited to: growth factor, transfusion support, immunomodulatory (IMID) therapy, DNA hypomethylating therapy or cytotoxic chemotherapy prior to trial registration.
    4. Age 50.0-75.0 years.
    5. Karnofsky performance status > 70 or Eastern Cooperative Oncology Group (ECOG) ≤ 1 (see comparison scale in Appendix D).
    6. Patients are eligible if no formal unrelated donor search has been activated prior to enrollment. Patients who have started a sibling donor search or who have found a matched sibling donor are eligible.
    7. Patients and physicians must be willing to comply with treatment assignment:

      1. No intent to proceed with alloHCT using donor sources not specified in this protocol, including Human leukocyte antigen (HLA)-mismatched related or unrelated donors < 6/6 HLA related matched or < 8/8 HLA unrelated matched) or umbilical cord blood unit(s).
      2. No intent to use myeloablative conditioning regimens.
      3. Intent to proceed with RIC alloHCT if a matched sibling or matched unrelated donor is identified. There is no requirement as to the timing of the transplantation.
    8. Patients must be considered to be suitable RIC alloHCT candidates at the time of enrollment based on medical history, physical examination and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used to judge eligibility.
    9. Signed informed consent

Exclusion Criteria:

  • Patients with the following will be ineligible for registration onto this study:

    1. Therapy-related MDS
    2. Current or prior diagnosis of AML
    3. Uncontrolled bacterial, viral or fungal infection
    4. Concurrent malignancy other than superficial squamous cell or basal cell carcinoma of the skin
    5. Prior autologous or allogeneic HCT
    6. Human Immunodeficiency Virus (HIV) infection
    7. Fertile patients unwilling to use contraceptive techniques
    8. Patients with psychosocial conditions that would prevent study compliance
Both
50 Years to 75 Years
No
Contact: Linda Johnson, MD, MS 301-251-1161 ext 2834 ljohnson@emmes.com
United States
 
NCT02016781
BMTCTN1102, 2U10HL069294-11
Yes
Medical College of Wisconsin
Medical College of Wisconsin
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Cancer Institute (NCI)
  • Blood and Marrow Transplant Clinical Trials Network
Study Director: Mary Horowitz, MD, MS Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Medical College of Wisconsin
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP