Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01812252
First received: March 14, 2013
Last updated: January 29, 2015
Last verified: January 2015

March 14, 2013
January 29, 2015
April 2013
October 2016   (final data collection date for primary outcome measure)
Failure-free survival (failure defined as death or relapse) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Failure-free survival (failure defined as death, lack of response to initial therapy, relapse after response to initial therapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01812252 on ClinicalTrials.gov Archive Site
  • Frequency at which the patients undergo transplantation [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    The quality-of-life questionnaires will be scored. Absolute scores and a distribution-based interpretation will be reported using the standardized response mean to analyze changes in scores over time and differences between groups.
  • Overall Survival [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Frequency at which the patients undergo transplantation [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Factors present at enrollment that predict transplant frequency [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Reasons for which patients were not transplanted [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in comorbidities [ Time Frame: Baseline and time of transplant ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
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 hematopoietic stem cell transplant helps stop the growth of cancer cells before, 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 cytarabine IV continuously over 24 hours for 7 days and idarubicin IV or daunorubicin hydrochloride IV on days 1-3 at the discretion of the treating physician. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndrome
  • Secondary Myelodysplastic Syndrome
  • Drug: Decitabine
    Given IV or SC
    Other Names:
    • 5AZA
    • DAC
  • Drug: Azacitidine
    Given IV or SC
    Other Names:
    • 5-AC
    • 5-AZC
    • U-18496
  • Drug: Cytarabine
    Given IV
    Other Names:
    • CHX-3311
    • U-19920
  • Drug: Idarubicin
    Given IV
    Other Names:
    • Idamycin
    • IMI-30
    • SC-33428
    • Zavedos
  • Drug: Daunorubicin Hydrochloride
    Given IV
    Other Names:
    • DNM
    • DNR
    • DRB
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Experimental: Arm A (decitabine or azacitidine)
    Patients receive decitabine or azacitidine IV or 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.
    Interventions:
    • Drug: Decitabine
    • Drug: Azacitidine
    • Other: Quality-of-Life Assessment
  • Experimental: Arm B (cytarabine, idarubicin or daunorubicin hydrochloride)
    Patients receive cytarabine IV continuously over 24 hours for 7 days and idarubicin IV or daunorubicin hydrochloride IV on days 1-3 at the discretion of the treating physician. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Cytarabine
    • Drug: Idarubicin
    • Drug: Daunorubicin Hydrochloride
    • 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
October 2016   (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)
Both
18 Years and older
No
United States
 
NCT01812252
2661.00, NCI-2013-00538, 2661, 2661.00, P30CA015704
No
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Bart Scott Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
January 2015

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