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Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant (ICT-HCT)

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01812252
First received: March 14, 2013
Last updated: October 10, 2016
Last verified: October 2016
March 14, 2013
October 10, 2016
April 2013
September 2017   (Final data collection date for primary outcome measure)
Failure-free survival (failure defined as death or relapse) [ Time Frame: 18 months ]
Failure-free survival (failure defined as death, lack of response to initial therapy, relapse after response to initial therapy) [ Time Frame: 18 months ]
Complete list of historical versions of study NCT01812252 on ClinicalTrials.gov Archive Site
  • 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 ]
    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.
  • Frequency at which the patients undergo transplantation [ Time Frame: Up to 18 months ]
  • Overall Survival [ Time Frame: Up to 18 months ]
  • Relapse [ Time Frame: Up to 18 months ]
  • Frequency at which the patients undergo transplantation [ Time Frame: Up to 18 months ]
  • Factors present at enrollment that predict transplant frequency [ Time Frame: Up to 18 months ]
  • Reasons for which patients were not transplanted [ Time Frame: Up to 18 months ]
  • Changes in quality of life scores using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: Baseline and up to 18 months ]
  • Change in comorbidities [ Time Frame: Baseline and time of transplant ]
  • Overall Survival [ Time Frame: Up to 18 months ]
  • Relapse [ Time Frame: Up to 18 months ]
  • Relapse-free survival [ Time Frame: Up to 18 months ]
  • Incidence of acute and chronic GVHD assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 18 months ]
Not Provided
Not Provided
 
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndrome
  • Secondary Myelodysplastic Syndrome
  • Drug: Azacitidine
    Given IV or SC
    Other Names:
    • 5 AZC
    • 5-AC
    • 5-Azacytidine
    • 5-AZC
    • Azacytidine
    • Azacytidine, 5-
    • Ladakamycin
    • Mylosar
    • U-18496
    • Vidaza
  • Drug: Decitabine
    Given IV or SC
    Other Names:
    • 5-Aza-2'-deoxycytidine
    • Dacogen
    • Decitabine for Injection
    • Deoxyazacytidine
    • Dezocitidine
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Arm A (decitabine or azacitidine)
    Patients 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.
    Interventions:
    • Drug: Azacitidine
    • Drug: Decitabine
    • Other: Quality-of-Life Assessment
  • Arm B (induction-like chemotherapy regimen)
    Patients 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.
    Intervention: Other: Quality-of-Life Assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
September 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT01812252
2661.00
NCI-2013-00538 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2661
2661.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
No
Not Provided
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Bart Scott Fred Hutch/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
October 2016

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