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Chemotherapy in Treating Patients Who Have Hematologic Cancer | Clinical Trials | Clareo Health

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Chemotherapy in Treating Patients Who Have Hematologic Cancer

A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase

NCT00004047•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating patients who have hematologic cancer.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of DX-8951f in patients with advanced myelodysplastic syndromes, refractory acute myeloid or lymphocytic leukemia, refractory or transformed chronic lymphocytic leukemia, or chronic myelogenous leukemia in blastic phase. II. Evaluate the quantitative and qualitative toxic effects of this regimen and determine the duration and reversibility of these effects in these patients. III. Make a preliminary determination of the antileukemic activity of this regimen in these patients. IV. Evaluate the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DX-8951f until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: Approximately 20-25 evaluable patients will be accrued for this study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS: One of the following hematologic malignancies: Advanced myelodysplastic syndromes Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia Refractory acute myeloid leukemia (AML) First salvage with primary refractory AML or first complete response (CR) no greater than 12 months in duration or at least second salvage therapy Once maximum tolerated dose is determined, intermediate AML prognosis (first CR duration greater than 12 months but less than 24 months) eligible Refractory acute lymphocytic leukemia Refractory or transformed chronic lymphocytic leukemia Chronic myelogenous leukemia in blastic phase No CNS disease
•PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.0 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No concurrent grade 4 infection No psychiatric disorder or mental disability No other life threatening illness
•PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: At least 30 days since prior cytotoxic therapy and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy to greater than 25% of skeleton Surgery: No concurrent surgery Other: At least 3 weeks since prior investigational drugs (including analgesics or antiemetics) Recovered from toxic effects of any prior therapy

Locations (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 1, 1999

Primary Completion Date

April 1, 2005

Completion Date

April 1, 2005

Last Updated

May 16, 2012

Conditions

LeukemiaMyelodysplastic Syndromes

Interventions

exatecan mesylate

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITING

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

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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: May 16, 2012Data 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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Chemotherapy in Treating Patients Who Have Hematologic Cancer

Inclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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