Clinical trial · Interventional
Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL
NCT00003174CI-TRIAL-00014338completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| cladribine | Drug | Cladribine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* See Disease Characteristics
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 50,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* Transaminases less than 2.5 times normal
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No history of severe coronary artery disease, cardiomyopathy, uncontrolled congestive heart failure, or arrhythmias
Neurologic:
* No prior drug-related neurotoxicity
* No other neurologic disorder
Other:
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior bone marrow transplantation
Chemotherapy:
* 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
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No other concurrent therapyReferences
Publications (1)
- BACKGROUNDAhmad I, Al-Katib AM, Beck FW, Mohammad RM. Sequential treatment of a resistant chronic lymphocytic leukemia patient with bryostatin 1 followed by 2-chlorodeoxyadenosine: case report. Clin Cancer Res. 2000 Apr;6(4):1328-32. PMID 10778958