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CC-1088 Therapy for Chronic Lymphocytic Leukemia: A Phase I/II Trial

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

CC-1088 Therapy for Chronic Lymphocytic Leukemia: A Phase I/II Trial

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy J. Ernst, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

July 2005

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Boston Medical Center Boston, Massachusetts  02118