Clinical Trial 17676

Cancer Type: Malignant Hematology
Interventions:

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Asmita Mishra

Overview

Study Title

A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Age 50 or Older with Intermediate-2 and High Risk Myelodysplastic Syndrome

Summary

The purpose of this study is to find out if a reduced-intensity transplant works better than the standard treatment for Myelodysplastic Syndrome (MDS).

Objective

Compare the three-year overall survival probabilities between the two study arms using an intent-to-treat analysis. Arm 1: RIC alloHCT Arm 2: Hypomethylating Therapy / Best Supportive Care 1. Compare leukemia-free survival (LFS) at 3 years from enrollment 2. Compare QOL measures between treatment arms

Inclusion Criteria

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  • Patients with de novo Myelodysplastic Syndrome (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.
  • Must have an acceptable MDS subtype: Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)); Refractory anemia with ringed sideroblasts (RARS); Refractory anemia with excess blasts (RAEB-1); Refractory anemia with excess blasts (RAEB-2); Refractory cytopenia with multilineage dysplasia (RCMD); Myelodysplastic syndrome with isolated del(5q) (5q- syndrome); Myelodysplastic syndrome (MDS), unclassifiable
  • Participants must have fewer than 20% marrow blasts within 60 days of consent.
  • 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 enrollment.
  • Age 50.0-75.0 years
  • Karnofsky performance status > 70 or Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Patients are eligible if no formal unrelated donor search has been activated prior to date of consent. A formal unrelated donor search begins at the time at which samples are requested from potential NMDP donors. Patients who have started a sibling donor search or who have found a matched sibling donor are eligible.
  • 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.
  • Signed informed consent

  • Exclusion Criteria

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  • Therapy-related MDS (defined as the occurrence of MDS due to prior exposure to systemic chemotherapy and/or radiation for malignancy)
  • Current or prior diagnosis of AML
  • Chronic myelomonocytic leukemia or myelodysplastic/myeloproliferative neoplasm (unacceptable MDS subtypes); uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement) at time of enrollment.
  • Patients with prior malignancies, except treated non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative surgery without chemotherapy/radiation therapy > 5 years previously will be allowed. Cancer treated with curative surgery > Prior autologous or allogeneic HCT
  • Human Immunodeficiency Virus (HIV) infection
  • Patients of childbearing potential unwilling to use contraceptive techniques
  • Patients with psychosocial conditions that would prevent study compliance