Clinical Trials /

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant

NCT01812252

Description:

This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Related Conditions:
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
  • Official Title: Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

Clinical Trial IDs

  • ORG STUDY ID: 2661.00
  • SECONDARY ID: NCI-2013-00538
  • SECONDARY ID: 2661
  • SECONDARY ID: 2661.00
  • SECONDARY ID: P30CA015704
  • SECONDARY ID: RG9215001
  • NCT ID: NCT01812252

Conditions

  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Secondary Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
Azacitidine5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, VidazaArm A (decitabine or azacitidine)
Decitabine5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, DezocitidineArm A (decitabine or azacitidine)

Purpose

This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia
      [AML]-like therapy), versus less intensive hypomethylating agents (HMA) as initial therapy,
      on failure-free survival.

      SECONDARY OBJECTIVES:

      I. Determine if IC (intensive AML-like therapy) in comparison to HMA as initial therapy, will
      affect transplantation frequency and quality of life.

      II. Conduct exploratory analysis of post-HCT outcomes (overall survival, and relapse).

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC)
      for 7 days. Treatment repeats every 28 days for 4 courses of decitabine or 6 courses of
      azacitidine in the absence of disease progression or unacceptable toxicity.

      ARM B: Patients receive induction-like chemotherapy per standard of care or per experimental
      protocol. This study does not require a specific chemotherapy regimen for Arm B.

      After completion of study treatment, patients are followed up for 18 months.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A (decitabine or azacitidine)OtherPatients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 courses of decitabine or 6 courses of azacitidine in the absence of disease progression or unacceptable toxicity.
  • Azacitidine
  • Decitabine
Arm B (induction-like chemotherapy regimen)OtherPatients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Diagnosis of de novo or secondary myelodysplastic syndrome (MDS), including chronic
                 myelomonocytic leukemia, as defined by the 2008 World Health Organization
                 classification system
    
              -  Patients must have measurable disease requiring cytoreduction, defined as a bone
                 marrow myeloblast count >= 5% and < 20% on morphologic examination or by flow
                 cytometry in cases in which adequate morphologic examination is not possible
    
              -  Patients must be considered to have an acceptable risk of early mortality with
                 intensive chemotherapy as determined by the attending physician at the time of the
                 initial visit; since the specific therapy within each arm will be determined after
                 randomization, there is no threshold of organ dysfunction or performance status for
                 inclusion
    
              -  Considered a potential transplant candidate; the attending/treating physician will
                 determine transplant candidacy at the time of consent
    
              -  Capable of understanding the investigational nature, potential risks and benefits of
                 the study, and able to provide valid informed consent
    
            Exclusion Criteria:
    
              -  A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health
                 Organization classification system
    
              -  Previous treatment for MDS or AML with intensive chemotherapy regimen (induction
                 chemotherapy) or hypomethylating agent
    
              -  Have any other severe concurrent disease, or have a history of serious organ
                 dysfunction or disease involving the heart, kidney, liver, or other organ system that
                 may place the patient at undue risk to undergo treatment
    
              -  Patients with a systemic fungal, bacterial, viral, or other infection not controlled
                 (defined as exhibiting ongoing signs/symptoms related to the infection and without
                 improvement, despite appropriate antibiotics or other treatment)
    
              -  Females who are pregnant or breastfeeding
    
              -  Fertile men and women unwilling to use contraceptive techniques during and for 12
                 months following treatment
    
              -  Any uncontrolled or significant concurrent disease, illness, or psychiatric disorder
                 that would compromise patient safety or compliance, interfere with consent, study
                 participation, follow up, or interpretation of study results
    
              -  Clinical evidence suggestive of central nervous system (CNS) involvement with MDS
                 unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal
                 fluid (CSF)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Failure-free survival (failure defined as death or relapse)
    Time Frame:18 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Changes in quality of life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
    Time Frame:Baseline, pre-transplant, and up to 100 days post-transplant
    Safety Issue:
    Description:The quality-of-life questionnaires will be scored. Absolute scores will be reported. A distribution-based interpretation will be conducted using the standardized response mean to analyze changes in scores over time and differences between groups.
    Measure:Frequency at which the patients undergo transplantation
    Time Frame:Up to 18 months
    Safety Issue:
    Description:
    Measure:Overall Survival
    Time Frame:Up to 18 months
    Safety Issue:
    Description:
    Measure:Relapse
    Time Frame:Up to 18 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Fred Hutchinson Cancer Research Center

    Trial Keywords

    • myelodysplastic syndrome
    • chronic myelomonocytic leukemia
    • bone marrow transplant
    • hypomethylating agent
    • induction chemotherapy

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