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Phase 2 Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT01550224
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University

March 7, 2012
March 9, 2012
May 21, 2018
May 1, 2013
November 17, 2014   (Final data collection date for primary outcome measure)
Complete Remission [ Time Frame: 36 months ]
This study evaluates the clinical efficacy of temozolomide + vorinostat, as assessed by the rate of morphological complete remission (mCR) at 36 months. mCR is defined as the morphologic leukemia-free state (< 5% blasts in bone marrow sample that has marrow spicules; ≥ 200 nucleated cells; no blasts with Auer rods; no persistence of extramedullary disease) plus absolute neutrophil count (ANC) > 1,000/µL and platelets ≥ 100,000/µL.
Rate of morphological complete remission [ Time Frame: 36 months ]
The primary endpoint of the study is to determine the clinical efficacy, as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat in patients with AML and poor prognostic features.
Complete list of historical versions of study NCT01550224 on ClinicalTrials.gov Archive Site
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Phase 2 Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)
A Phase 2 Study of Temozolomide Plus Vorinostat in Patients With Relapse/Refractory Acute Myeloid Leukemia (AML)
The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.
The primary endpoint of the study is to determine the clinical efficacy as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat administered to 2 distinct groups of participants patients with AML and poor prognostic features. Participants will be allocated to treatment on the basis of O6-methylguanine DNA methyltransferase (MGMT) promoter methylation status.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia With 11q23-abnormality in Relapse
  • Drug: Temozolomide

    An alkylating agent administered:

    Group 2: 100 mg/m²/day for 14 days Both groups: 200 mg/m²/day for 7days

    Other Names:
    • Temodar
    • Temodal
    • Temcad
    • TMZ
  • Drug: Vorinostat
    A synthetic hydroxamic acid derivative with antineoplastic activity administered at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day.
    Other Name: Zolinza
  • Active Comparator: Group 1 - Methylated MGMT promoter
    Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).
    Interventions:
    • Drug: Temozolomide
    • Drug: Vorinostat
  • Active Comparator: Group 2 - Non-Methylated MGMT promoter
    Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).
    Interventions:
    • Drug: Temozolomide
    • Drug: Vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
45
November 17, 2014
November 17, 2014   (Final data collection date for primary outcome measure)
Not Provided
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01550224
IRB-22794
HEMAML0017 ( Other Identifier: OnCore )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Bruno C. Medeiros, Stanford University
Stanford University
Merck Sharp & Dohme Corp.
Principal Investigator: Bruno Carneiro de Medeiros, MD Stanford University
Stanford University
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP