Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia

NCT00006097 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000068104BUMC-5092NCI-V00-1603
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia

Interventions

CC-1088 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy J. Ernst, MD

  Boston Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: May 4, 2004
• Study Start: August 1, 1999
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: September 22, 2010

Record last verified: 2001-05

Locations

US (1)