Clinical trial · Interventional
Bryostatin + Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma
Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma
- 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 cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed chronic lymphocytic leukemia
* Stage I (symptomatic or with bulky lymphadenopathy)
* Stage II, III, or IV
* Prior chemotherapy allowed, including fludarabine or other purine nucleoside analog therapy OR
* Histologically confirmed indolent non-Hodgkin's lymphoma
* Progressive or relapsed following chemotherapy
* Includes the following histologies:
* B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas
* Lymphoplasmacytoid lymphoma (Waldenstrom's)/immunocytoma
* Mantle cell lymphoma
* Follicular lymphoma
* Small cell
* Mixed small and large cell
* Diffuse (predominately small cell type)
* Marginal zone B-cell lymphoma
* Extranodal (MALT-type with or without monocytoid B-cells)
* Provisional subtype: nodal (with or without monocytoid B-cells)
* Provisional entity: splenic marginal zone lymphoma (with or without villous lymphocytes)
* Hairy cell leukemia
* Peripheral T-cell and NK-cell neoplasms
* T-cell chronic lymphocytic leukemia/polylymphocytic leukemia
* Large granular lymphocyte leukemia
* T-cell type
* NK-cell type
* Mycosis fungoides/Sezary's syndrome (cutaneous T-cell lymphoma)
* No CNS disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,000/mm3
* Platelet count at least 75,000/mm3
* Hemoglobin at least 8 g/dL
* Coombs negative
Hepatic:
* AST/ALT no greater than 2.5 times upper limit of normal
* Bilirubin no greater than 2 mg/mL
Renal:
* Creatinine clearance at least 40 mL/min
Other:
* No concurrent neurologic condition
* No other concurrent medical condition that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent systemic immunoglobulin therapy
* No prior bone marrow or peripheral stem cell transplantation
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior systemic chemotherapy
Endocrine therapy:
* No concurrent systemic glucocorticoid therapy
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No other concurrent anticancer therapyReferences
Publications (1)
- RESULTRoberts JD, Smith MR, Feldman EJ, Cragg L, Millenson MM, Roboz GJ, Honeycutt C, Thune R, Padavic-Shaller K, Carter WH, Ramakrishnan V, Murgo AJ, Grant S. Phase I study of bryostatin 1 and fludarabine in patients with chronic lymphocytic leukemia and indolent (non-Hodgkin's) lymphoma. Clin Cancer Res. 2006 Oct 1;12(19):5809-16. doi: 10.1158/1078-0432.CCR-05-2730. PMID 17020988