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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 January 2023 |
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Main ID: |
NCT01812252 |
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Date of registration:
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14/03/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
ICT-HCT |
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Scientific title:
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Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study) |
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Date of first enrolment:
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April 2, 2013 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01812252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Bart L. Scott |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fred Hutch/University of Washington Cancer Consortium |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myelodysplastic Syndrome
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Secondary Myelodysplastic Syndrome
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Chronic Myelomonocytic Leukemia
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de Novo Myelodysplastic Syndrome
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Intervention(s)
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Drug: Decitabine
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Drug: Azacitidine
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Other: Quality-of-Life Assessment
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Primary Outcome(s)
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Failure-free survival (failure defined as death or relapse)
[Time Frame: 18 months]
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Secondary Outcome(s)
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Relapse
[Time Frame: Up to 18 months]
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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]
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Frequency at which the patients undergo transplantation
[Time Frame: Up to 18 months]
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Overall Survival
[Time Frame: Up to 18 months]
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Secondary ID(s)
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2661
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NCI-2013-00538
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2661.00
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RG9215001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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