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

This study is currently recruiting participants.
Verified December 2017 by Fred Hutchinson Cancer Research Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01812252
First Posted: March 18, 2013
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
  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.

Condition Intervention Phase
Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndrome Myelodysplastic Syndrome Secondary Myelodysplastic Syndrome Drug: Azacitidine Drug: Decitabine Other: Quality-of-Life Assessment Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Failure-free survival (failure defined as death or relapse) [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Actual Study Start Date: April 2, 2013
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812252


Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Mayo Clinic Clinical Trials Office    855-776-0015    cancerclinicaltrials@mayo.edu   
Principal Investigator: Nandita Khera         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Aaron T. Gerds    216-444-6833    gerdsa@ccf.org   
Principal Investigator: Aaron T. Gerds         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Bart L. Scott    206-667-1990    bscott@fhcrc.org   
Principal Investigator: Bart L. Scott         
Kaiser Permanente Washington Terminated
Seattle, Washington, United States, 98112
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bart Scott Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01812252     History of Changes
Other Study ID Numbers: 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 ( U.S. NIH Grant/Contract )
First Submitted: March 14, 2013
First Posted: March 18, 2013
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fred Hutchinson Cancer Research Center:
myelodysplastic syndrome
chronic myelomonocytic leukemia
bone marrow transplant
hypomethylating agent
induction chemotherapy

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Myelodysplastic-Myeloproliferative Diseases
Azacitidine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors