Completed

A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia

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What is being tested

Data Collection

Who is being recruted

Chronic Disease
+14

+ Hematologic Diseases
+ Immune System Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorNational Institute on Aging (NIA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the feasibility and safety of bryostatin 1 and rituximab in patients with rituximab-refractory indolent B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia (CLL). * Determine the antitumor response in patients treated with this regimen. Secondary * Determine the effects of this regimen on the functional and molecular status of effector cells (i.e., NK cells, monocytes, and dendritic cells) in these patients. * Determine the expression of CD20 and complement-inhibitory molecules on tumor cells before and after treatment with this regimen in these patients. * Determine the effects of this regimen on the global gene expression pattern in CLL cells of these patients. OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV continuously over 24 hours on days -6, 2, and 9 of course 1 and on days 2 and 9 of courses 2-6. Patients also receive rituximab IV over 4 hours on days 1, 8, 15, and 22 of courses 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 18-48 patients (9-24 with non-Hodgkin's lymphoma and 9-24 with chronic lymphocytic leukemia) will be accrued for this study within 12-30 months.

Official TitleA Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia 
NCT00087425
Principal SponsorNational Institute on Aging (NIA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
48 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Disease Attributes
Criteria

DISEASE CHARACTERISTICS: * One of the following histologically or cytologically confirmed diseases: * Indolent B-cell non-Hodgkin's lymphoma (NHL) * Stage II-IV disease * Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria: * Intermediate-risk with progressive disease * High-risk, modified Rai stage disease * CD20-positive by flow cytometry or immunohistochemistry * Measurable disease * Rituximab-refractory disease, defined as failure to achieve a response to the last course of prior treatment with rituximab alone or in combination with other therapeutic modalities * No known neoplastic leptomeningeal involvement and/or brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 50,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal (unless due to Gilbert's disease or organ involvement by NHL or CLL) Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to murine protein * Prior infusion reactions to rituximab without an IgE component allowed * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Radiotherapy * At least 12 weeks since prior rituximab * More than 4 weeks since prior immunotherapy and recovered Chemotherapy * No more than 3 prior chemotherapy regimens * More than 4 weeks since prior chemotherapy and recovered Endocrine therapy * No concurrent glucocorticoids Radiotherapy * At least 12 weeks since prior radioimmunotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * At least 4 weeks since prior therapy for the malignancy * No other concurrent anticancer therapy * No other concurrent investigational agents


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
NIH - Warren Grant Magnuson Clinical CenterBethesda, United StatesSee the location

CompletedOne Study Center
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