Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant - Full Text View

Purpose

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.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Leukemia Myelodysplastic Syndromes

Drug Information available for: Cytarabine Azacitidine Decitabine Daunorubicin Daunorubicin hydrochloride Idarubicin hydrochloride Idarubicin Daunorubicin citrate

Genetic and Rare Diseases Information Center resources: Chronic Myelomonocytic Leukemia Leukemia, Myeloid Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	60
Study Start Date:	April 2013
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Decitabine Given IV or SC Other Names: 5AZA DAC Drug: Azacitidine Given IV or SC Other Names: 5-AC 5-AZC U-18496 Other: Quality-of-Life Assessment Ancillary studies Other Name: 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.	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

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 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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812252

Locations


United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Recruiting
Seattle, Washington, United States, 98109
Contact: Bart L. Scott 206-667-1990
Principal Investigator: Bart L. Scott
Group Health Cooperative-Seattle	Recruiting
Seattle, Washington, United States, 98112
Contact: Eric Y. Chen 206-326-3111
Principal Investigator: Eric Y. Chen

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Bart Scott	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

More Information

No publications provided


Responsible Party:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT01812252 History of Changes
Other Study ID Numbers:	2661.00, NCI-2013-00538, 2661, 2661.00, P30CA015704
Study First Received:	March 14, 2013
Last Updated:	January 29, 2015
Health Authority:	United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:


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

Additional relevant MeSH terms:


Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Preleukemia Syndrome Bone Marrow Diseases Disease Hematologic Diseases Leukemia Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Precancerous Conditions Azacitidine	Cytarabine Daunorubicin Decitabine Idarubicin Anti-Infective Agents Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions

ClinicalTrials.gov processed this record on February 27, 2015