temozolomide and Leukemia, Myeloid

temozolomide has been researched along with Leukemia, Myeloid in 3 studies

Leukemia, Myeloid: Form of leukemia characterized by an uncontrolled proliferation of the myeloid lineage and their precursors (MYELOID PROGENITOR CELLS) in the bone marrow and other sites.

Research

Studies (3)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide

Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. (NCT00687323)
Timeframe: Up to 1 year after treatment ends (up to 115 weeks)

Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity

Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions. (NCT00687323)
Timeframe: From first dose to 30 days after last dose of study drug (up to 67 weeks)

Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression

Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers. (NCT00687323)
Timeframe: Baseline

Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide

"OS was defined as the time from start of treatment until death or end of study.~Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent." (NCT00687323)
Timeframe: Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)]

Progression-free Survival for Participants Achieving PR, MLSF, or MR

Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts. (NCT00687323)
Timeframe: Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]

Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide

Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. (NCT00687323)
Timeframe: Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]

Clinical Response at the End of Temozolomide Induction

"Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.~CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.~Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met.~Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts." (NCT00687323)
Timeframe: at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks

Trials

1 trial available for temozolomide and Leukemia, Myeloid

Other Studies

2 other studies available for temozolomide and Leukemia, Myeloid