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Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00611247•Bruno C. Medeiros

View on ClinicalTrials.gov

Summary

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

Detailed Description

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).

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have histologically or cytologically confirmed Acute Myeloid Leukemia, as defined by the WHO classification.
•2. Patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease.
•3. For patients who have received no prior conventional chemotherapy, one of the following must be present:
•* Poor risk cytogenetics (complex abnormalities, deletions of chromosome 7 or 5, 11q23 abnormalities, inv\[3\])
•* Secondary leukemia (prior hematologic disorder or therapy-related leukemia).
•4. Age \> 60 years of age.
•5. Life expectancy of greater than 3 months.
•6. ECOG performance status greater than 2.
•7. Patients must have normal organ and marrow function as defined below:
•8. Adequate hepatic function: Total bilirubin 1.5mg/dL, AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal.
+2 more criteria

Exclusion Criteria

•1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•2. Patients may not be receiving any other investigational agents.
•3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or DTIC
•4. History of gastrointestinal disease or significant bowel resection that could interfere with drug absorption.
•5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•6. Prior allogeneic stem cell transplantation.
•7. Inability to swallow tablets
•8. Prior radiation up to more than 25% of bone marrow.

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Key Dates

Start Date

December 1, 2007

Primary Completion Date

December 1, 2009

Completion Date

January 1, 2010

Last Updated

June 15, 2018

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid

Interventions

Temozolomide

DRUG

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NCT06852222

Leukemia, Myeloid, Acute

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RECRUITING

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Leukemia, Myeloid, Acute

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RECRUITINGPHASE1

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

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