A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
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ClinicalTrials.gov Identifier: NCT01483690 |
Recruitment Status :
Terminated
(Toxicity)
First Posted : December 1, 2011
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | November 29, 2011 | |||
First Posted Date ICMJE | December 1, 2011 | |||
Results First Submitted Date ICMJE | September 8, 2020 | |||
Results First Posted Date ICMJE | October 27, 2020 | |||
Last Update Posted Date | October 27, 2020 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | July 31, 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT). [ Time Frame: 6 weeks ] To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.
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Original Primary Outcome Measures ICMJE |
Number of participants with adverse events. [ Time Frame: 6 weeks ] To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Disease Response Rate After Treatment. [ Time Frame: 6 weeks ] Bone marrow evaluation was performed on Day 35 of study to evaluate treatment response. CR defined as attaining M1 marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease in addition to recovery of peripheral blood counts (ANC >750/uL and platelet count >75,000/uL). CRp was defined as attaining an M1 marrow with no evidence of circulating blasts or extramedullary disease in addition to recovery of ANC but insufficient recovery of platelets. CRi was attaining M1 marrow with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC with or without sufficient recovery of platelets. PR was defined as no evidence of circulating blasts and achievement of M2 marrow (5-25% blasts) without new sites of disease and with recovery of ANC. SD is for patients who did not meet the criteria for PR, CR, CRp, or CRi. PD is an increase of at least 25% in the absolute number of leukemia cells or development of new sites.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL | |||
Official Title ICMJE | A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL | |||
Brief Summary | This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL). | |||
Detailed Description | Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of demethylating agents and HDAC inhibitors in combination have been previously shown to have synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This study will ask the question as to whether or not the combination of decitabine and vorinostat followed by chemotherapy is feasible and whether it can positively impact outcome in patients with relapsed or refractory acute lymphoblastic leukemia. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
23 | |||
Original Estimated Enrollment ICMJE |
16 | |||
Actual Study Completion Date ICMJE | July 31, 2015 | |||
Actual Primary Completion Date | July 31, 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Diagnosis
Renal and Hepatic Function
Cardiac Function:
Reproductive Function
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 21 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, United States | |||
Removed Location Countries | Canada | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01483690 | |||
Other Study ID Numbers ICMJE | T2009-003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Therapeutic Advances in Childhood Leukemia Consortium | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Therapeutic Advances in Childhood Leukemia Consortium | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Therapeutic Advances in Childhood Leukemia Consortium | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |