Status:
COMPLETED
Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Leukemia, Acute Myeloid
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants who are not ca...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of acute myeloid leukemia (AML), any subtype except acute promyelocytic leukemia (APL), by the World Health Organization (WHO) criteria, or high risk MDS with blasts between 10 and 20% in the bone marrow.
- No prior AML chemotherapy except hydroxyurea.
- Leukemic blast count \<30x10\^9/L at the start of therapy. Prior cytoreduction with hydroxyurea (maximum 14 days) is permitted.
- Participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex \[\>3\] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary AML (antecedent hematologic disorder or therapy-related AML); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy.
- Confirmed low MGMT expression (MGMT: beta-actin ≤0.2), as evaluated by Western blot, or weak MGMT expression defined as \> 0.2 and ≤2.5 if promoter is methylated, upon Sponsor approval.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Use of medically approved contraception in fertile males and females.
- Negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to Baseline).
Exclusion
- Serum bilirubin \>2 times the upper limit of normal (ULN), or serum aspartate aminotransferase/ alanine aminotransferase \>5 times ULN.
- Serum creatinine \>200 umol/L.
- History of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ.
- Presence of active uncontrolled infection.
- Known human immunodeficiency virus (HIV) infection.
- Any medical condition that may interfere with protocol evaluation or oral medication intake.
- Prior chemotherapy other than hydroxyurea.
Key Trial Info
Start Date :
July 30 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00687323
Start Date
July 30 2007
End Date
December 23 2012
Last Update
June 7 2017
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