Completed

ICT-HCTInitial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

What is being tested

Azacitidine (AZC)

+ Decitabine

+ Quality-of-Life Assessment

DrugOther

Who is being recruted

Bone Marrow Diseases+11

+ Chronic Disease

+ Hematologic Diseases

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: August 2013

See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center

Last updated: February 15, 2024

Sourced from a government-validated database.Claim as a partner

Study start date: August 19, 2013

Actual date on which the first participant was enrolled.

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 cycles of decitabine or 6 cycles 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.

NCT01812252

Principal SponsorFred Hutchinson Cancer Center

Last updated: February 15, 2024

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesMyelodysplastic-Myeloproliferative DiseasesMyelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic

Criteria

5 inclusion criteria required to participate

Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent

Considered a potential transplant candidate; the attending/treating physician will determine transplant candidacy at the time of consent

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 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

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8 exclusion criteria prevent from participating

A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health Organization classification system

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)

Females who are pregnant or breastfeeding

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Mayo Clinic in Arizona

Scottsdale, United StatesOpen Mayo Clinic in Arizona in Google Maps

Cleveland Clinic Foundation

Cleveland, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, United States

Kaiser Permanente Washington

Seattle, United States

Completed4 Study Centers