Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed 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: NCT00003174
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 24, 2014
National Cancer Institute (NCI)
Information provided by:
Barbara Ann Karmanos Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: bryostatin 1 Drug: cladribine Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of cladribine when administered after bryostatin 1 in patients with relapsed chronic lymphocytic leukemia.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of cladribine.

Patients receive bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR.

Cohorts of 3-6 patients receive escalating dose levels of cladribine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Primary Purpose: Treatment
Official Title: Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL
Study Start Date : May 1998
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Cladribine

Information from the National Library of Medicine

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


  • Diagnosis of relapsed chronic lymphocytic leukemia

    • Intermediate- or high-risk (stage I-IV) disease
  • Intermediate-risk patients must have active disease, defined by at least 1 of the following criteria:

    • Presence of any 1 of the following disease-related B symptoms:

      • 10% or more loss of body weight within the past 6 months
      • Extreme fatigue
      • Fever greater than 100 degrees Fahrenheit without evidence of infection
      • Night sweats
    • Massive (greater than 6 cm below left costal margin) or progressive splenomegaly
    • Massive (greater than 10 cm in longest diameter) or progressive lymphadenopathy
    • Progressive lymphocytosis with an increase of more than 50% over a 2-month period or anticipated doubling time of less than 12 months
    • Progressive bone marrow failure as manifested by the development or worsening of anemia and/or thrombocytopenia
    • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids
  • Failed 1-2 prior front-line regimens
  • Failed prior fludarabine
  • Ineligible for any known treatment of higher potential efficacy



  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 12 weeks


  • See Disease Characteristics
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3


  • Bilirubin less than 1.5 mg/dL
  • Transaminases less than 2.5 times normal


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No history of severe coronary artery disease, cardiomyopathy, uncontrolled congestive heart failure, or arrhythmias


  • No prior drug-related neurotoxicity
  • No other neurologic disorder


  • Not pregnant or nursing
  • Fertile patients must use effective barrier or non-hormonal contraception during and for 2 months after study participation
  • No HIV infection
  • No AIDS


Biologic therapy:

  • No prior bone marrow transplantation


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent steroids
  • No concurrent hormonal contraceptives


  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified


  • No other concurrent therapy

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): NCT00003174

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48202-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Ayad M. Al-Katib, MD, FACP Barbara Ann Karmanos Cancer Institute

Publications: Identifier: NCT00003174     History of Changes
Other Study ID Numbers: CDR0000065984
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory 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
Bryostatin 1
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic