Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006097
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : September 22, 2010
Information provided by:
Boston Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Drug: CC-1088 Phase 1 Phase 2

Detailed Description:

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.

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: CC-1088 Therapy for Chronic Lymphocytic Leukemia: A Phase I/II Trial
Study Start Date : August 1999
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006097

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Study Chair: Timothy J. Ernst, MD Boston Medical Center

Responsible Party: Timothy Ernst, MD, Boston Medical Center Identifier: NCT00006097     History of Changes
Other Study ID Numbers: CDR0000068104
First Posted: May 4, 2004    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: May 2001

Keywords provided by Boston Medical Center:
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell