Status:
COMPLETED
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia. PURPOSE: This phase II trial is studyi...
Detailed Description
OBJECTIVES: Primary * Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox. Secondary * Det...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse):
- Absolute lymphocytosis \> 5,000/mm\^3
- Lymphocytes must appear mature with \< 55% prolymphocytes
- More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear
- Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy
- Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping
- High-risk disease OR intermediate-risk disease
- Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria:
- Massive or progressive splenomegaly and/or adenopathy
- Weight loss \> 10% within the past 6 months
- Common toxicity grade 2-4 fatigue
- Fevers \> 100.5°F OR night sweats for more than 2 weeks without evidence of infection
- Progressive lymphocytosis with an increase of \> 50% over a 2-month period or an anticipated doubling time of \< 6 months
- Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria:
- Refractory or intolerant to fludarabine
- Relapsed within 6 months after completion of fludarabine
- No CNS leukemia
- No mantle cell lymphoma in leukemic phase
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- More than 2 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 50,000/mm\^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- Hepatic
- Albumin ≥ 3 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- No hepatitis B or C infection
- Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 40 mL/min
- Cardiovascular
- LVEF ≥ 40%
- Other
- No uncontrolled infection
- No other concurrent serious illness
- No HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior denileukin diftitox allowed
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- No concurrent corticosteroids as anti-emetics
- Radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- At least 28 days since prior anticancer therapy and recovered
- No other concurrent antineoplastic drugs
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00082940
Start Date
August 1 2002
End Date
June 1 2005
Last Update
January 19 2017
Active Locations (11)
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1
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868-3849
2
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
3
Medical Center Vincennes
Vincennes, Indiana, United States, 47591
4
Cancer Care Specialists
Houma, Louisiana, United States, 70360