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Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hematologic Neoplasms, Lymphoproliferative Disorders, Leukemia, Leukemia, Lymphocytic, Chronic

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Trial Information

Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies


The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1
hour daily for 5 days. Dosage escalation will be permitted in individual patients if no
toxicity occurred during the preceding course. Subsequent dose escalations will be by 50%
until Grade 2 toxicity, then by 35% until the maximum tolerated dose.

Inclusion Criteria


Inclusion criteria:

- Diagnosis of chronic lymphocytic leukemia

- Diagnosis of other acute leukemia

- At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy

- Recovered from toxic effects of prior therapy

- Bilirubin no greater than 2 mg/dL

- Creatinine no greater than 1.5 mg/dL

Exclusion criteria:

- Candidate for treatment of higher efficacy or priority

- Pregnant or nursing

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Hagop M. Kantarjian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

FD-R-1972-01

NCT ID:

NCT00028418

Start Date:

February 1999

Completion Date:

March 2001

Related Keywords:

  • Hematologic Neoplasms
  • Lymphoproliferative Disorders
  • Leukemia
  • Leukemia, Lymphocytic, Chronic
  • Acute Leukemia
  • Chronic Lymphocytic Leukemia
  • Antineoplastic Agents
  • Nucleosides
  • Dose-Response Relationship, Drug
  • Cladribine
  • Fludarabine
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoproliferative Disorders
  • Hematologic Neoplasms

Name

Location
University of Texas M. D. Anderson Cancer Center Houston, Texas  77030