Clinical trial · Interventional
Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia, or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation
Phase I Study of Oral ß-Glucan and Intravenous Rituximab Among Children and Adolescents With Relapsed CD20-Positive Lymphoma or Leukemia, or Post-Transplant Lymphoproliferative Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Beta-glucan may increase the effectiveness of rituximab by making cancer cells more sensitive to the monoclonal antibody. PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with rituximab in treating young patients with relapsed or progressive lymphoma or leukemia or with lymphoproliferative disorder related to donor stem cell transplantation.
Conditions
Conditions (3)
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 |
|---|---|---|---|
| beta-glucan | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Patients receive rituximab IV on days 1, 8, 15, and 22 and oral beta-glucan once daily on days 1-28 (days 8-28 of course 1). Treatment repeats every 42 days for 4 courses.
- interventionNames
- Biological: beta-glucan
- Biological: rituximab
- type
- EXPERIMENTAL
- label
- Group II
- description
- Patients receive rituximab IV on days 1, 4, 8, 15, and 22 and oral beta-glucan once daily on days 8-28. Beginning on day 42, patients with responding disease may receive monthly rituximab prophylaxis.
- interventionNames
- Biological: beta-glucan
- Biological: rituximab
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * B-cell non-Hodgkin's lymphoma (NHL) * Hodgkin's lymphoma * Post-transplant lymphoproliferative disorder (PTLD) * Lymphoblastic leukemia * CD20-positive disease verified by immunophenotyping at original diagnosis, disease relapse, or disease progression * Refractory to conventional therapy, defined as 1 of the following: * Medically refractory HIV-associated NHL * Refractory or recurrent lymphoblastic leukemia * PTLD * In \> first relapse or progression of B-cell NHL or Hodgkin's lymphoma * Measurable (CT scan or MRI) or evaluable (marrow metastases or circulating lymphoblasts) disease within 4 weeks after completion of prior systemic (including systemic steroids) therapy PATIENT CHARACTERISTICS: Age * Under 22 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 500/mm\^3\* * Platelet count \> 10,000/mm\^3\* NOTE: \*Excluding patients with PTLD or CD20-positive lymphoblastic leukemia Hepatic * Hepatic toxicity ≤ grade 2 Renal * Creatinine clearance ≥ 60 mL/min * Renal toxicity ≤ grade 2 Cardiovascular * Cardiac toxicity ≤ grade 2 Pulmonary * Pulmonary toxicity ≤ grade 2 Immunologic * Human anti-mouse antibody (HAMA) ≤ 1,000 units/mL * Human anti-chimeric antibody titer negative * No active, life-threatening infections except Epstein-Barr virus-associated lymphoproliferative disorder * No history of allergy to mouse proteins * No history of allergy to rituximab or other chimeric monoclonal antibodies * No history of allergy to beta-glucan or oats, barley, mushrooms, or yeast Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Grade 3 hearing deficit allowed * Gastrointestinal toxicity ≤ grade 2 * Neurologic toxicity ≤ grade 2 * No severe major organ toxicity PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 4 weeks since prior rituximab * No prior mouse antibodies * No prior chimeric antibodies Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available