Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Phase II Randomized Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) With or Without Valproic Acid in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia -"SPORE"
2 other identifiers
interventional
153
1 country
1
Brief Summary
The goal of this clinical research study is to find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 19, 2006
CompletedFirst Posted
Study publicly available on registry
December 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
August 13, 2015
CompletedMay 21, 2019
May 1, 2019
8.4 years
December 19, 2006
July 15, 2015
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML
Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with \< 5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 10\^9/ L, and a platelet count \> 100 x 10\^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets \<100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10\^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 x 10\^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to \<5% also considered clinical benefit.
1 Year
Secondary Outcomes (2)
Response Duration
Up to 60 months
Overall Survival Rate
Up to 7 years
Study Arms (2)
Decitabine
EXPERIMENTALDecitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
Decitabine + Valproic Acid
EXPERIMENTALDecitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
Interventions
20 mg/m\^2 IV over 1 hour daily for 5 days.
Eligibility Criteria
You may qualify if:
- Patients with MDS and \> 5% blasts or IPSS risk intermediate or high; patients with CMML; patients with AML who are age 60 or older. No prior intensive chemotherapy or high-dose ara-C (\> 1g/m2). No prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
- Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment. Procrit, granulocyte colony-stimulating factor (GCSF) are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
- Performance 0-2 (ECOG). Adequate liver function (bilirubin of \< 2mg/dl) and renal function (creatinine \< 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). ALT \< 2.5x institutional upper limit of normal.
- Signed informed consent.
You may not qualify if:
- Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Active and uncontrolled infections.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known ornithine transcarbamylase disorder.
- Patients requiring continuous valproic acid treatment for the control of seizure disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Eisai Inc.collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hagop Kantarjian, MD/Chair, Leukemia Department
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Hagop Kantarjian, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2006
First Posted
December 21, 2006
Study Start
December 1, 2006
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 21, 2019
Results First Posted
August 13, 2015
Record last verified: 2019-05