Hairy Cell Leukemia |
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Clinical Trial: Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia
This study is no longer recruiting patients.
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of CC-1088 in treating patients who have chronic lymphocytic leukemia that has not responded to previous therapy.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| refractory chronic lymphocytic leukemia B-cell Chronic Lymphocytic Leukemia | Drug: CC-1088 | Phase I Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of CC-1088 in Patients With Refractory, Progressive, B-Cell Chronic Lymphocytic Leukemia
Study start: August 1999
OBJECTIVES: I. Determine the toxicity of CC-1088 in patients with refractory, progressive, B-cell chronic lymphocytic leukemia. II. Determine the response rate to this treatment in these patients.
PROTOCOL OUTLINE: Patients receive oral CC-1088 three times a day for 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 11-20 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically or cytologically confirmed refractory, progressive, B-cell chronic lymphocytic leukemia; Failed prior first line therapy of chlorambucil or fludarabine (or their equivalent); Progressive disease as defined by at least one of the following: Greater than 50% increase in the sum of the products of at least 2 lymph nodes on two consecutive determinations 2 weeks apart (at least one lymph node must be greater than 2 cm); Appearance of new palpable lymph nodes; At least a 50% increase in size of previously palpable liver or spleen; Appearance of palpable hepatomegaly or splenomegaly not previously present; At least a 50% increase in the absolute lymphocyte count to at least 5,000/mm3; Transformation to an aggressive histology (e.g., Richter's or prolymphocytic leukemia)
- High risk OR Intermediate risk with active disease, as defined by the following: Greater than 10% weight loss; Extreme fatigue; Fevers greater than 100.5 Fahrenheit for greater than 2 weeks without infection; Night sweats; Splenomegaly greater than 6 cm; Lymphadenopathy greater than 10 cm; Lymphocytosis with a doubling time less than 6 months
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: See Disease Characteristics
- Endocrine therapy: Not specified
- Radiotherapy: Not specified
- Surgery: Not specified
--Patient Characteristics--
- Age: 18 and over
- Performance status: ECOG or Zubrod 0-2
- Life expectancy: Not specified
- Hematopoietic: See Disease Characteristics
- Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN); ALT and AST no greater than 2.5 times ULN
- Renal: Creatinine no greater than 2.0 mg/dL
- Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception during and for 2 weeks after study
Location Information
Massachusetts
Boston Medical Center, Boston, Massachusetts, 02118, United States
Timothy Jon Ernst, Study Chair, Boston Medical Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: August 3, 2000
ClinicalTrials.gov Identifier: NCT00006097
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Acute Lymphoblastic Leukemia, Adult (National Cancer Institute)
- Hairy Cell Leukemia (Cleveland Clinic)

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