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Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

OBJECTIVES: I. Determine the response rate in asymptomatic patients with stage 0, I, or II
B-cell chronic lymphocytic leukemia treated with theophylline. II. Determine the toxicity of
this treatment in these patients.

OUTLINE: Patients receive oral theophylline daily. Daily treatment continues for a maximum
of 6 months in the absence of disease progression or unacceptable toxicity. Patients are
followed every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study over approximately
10 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage 0, I, or II B-cell chronic
lymphocytic leukemia Stable disease that would otherwise be observed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 1 year Hematopoietic: Absolute lymphocyte count greater than 5,000/mm3 Mature
lymphocytes with less than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts Bone
marrow with at least 30% lymphocytes Hepatic: No cirrhosis Renal: Not specified
Cardiovascular: No history of unstable cardiac arrhythmia No active congestive heart
failure Other: No history of uncontrolled seizure disorder Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No other
concurrent condition that would make life expectancy less than 1 year

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent interferon alfa Chemotherapy: No
prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 months since
prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery:
Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Della Makower, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Federal Government

Study ID:




Start Date:

May 1999

Completion Date:

Related Keywords:

  • Leukemia
  • stage 0 chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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