Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Induction: 200 mg/m2/day oral Temozolomide x 7 days

Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days

Priming, Group 2 only, 100 mg/m2/day temozolomide.

Induction (both arms) 200 mg/m2/day temozolomide

Bruno Carneiro de Medeiros

Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis

This is a single institution phase 2 clinical trial evaluating the efficacy, safety, and tolerability of tailored temozolomide therapy for patients with acute myeloid leukemia (AML) and poor risk features.

Patients will be assigned to 1 of 2 parallel treatment groups based on their AGAT promoter region methylation status, as determined by PCR.

Patients achieving a complete remission after 1 to 2 cycles of chemotherapy will be eligible to receive up to an additional 5 cycles of temozolomide of 5 or 19 days, depending on the methylation status of the AGAT promoter (consolidation phase).

Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia

Phase II Study of Two Distinct Tailored Temozolomide Regimens for Patients With Acute Myeloid Leukemia Age > 60 Years and Poor Risk/Refractory Disease

Response determined per European LeukemiaNet response criteria:

CR = bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0 x 10e9/L; platelet count \> 100 x 10e9/L; and independence of red cell transfusions.

CRi = all CR criteria except for residual neutropenia (\< 1.0 x 10e9/L) or thrombocytopenia (\< 100 x 10e9/L)\].

Morphologic leukemia-free state (LFS) = bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; with no hematologic recovery required.

Relapse = bone marrow blasts \>5%; reappearance of blasts in the blood; or development of extramedullary disease.

Schering-Plough

Bruno C. Medeiros

Methylated AGAT Promoter (Group 1)

Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days

Spots Global Cancer Trial Database for Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia

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Study Description

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