Clinical trial · Interventional
Beta Alethine in Treating Patients With Low-Grade Lymphoma
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma
NCT00007839CI-TRIAL-00013066unknownPhase 1 / Phase 2ClinicalTrials.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: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have low-grade lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta alethine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed low grade B-cell lymphoma * Measurable residual disease after maximal response to prior chemotherapy OR * Indolent disease not yet requiring therapy * No congenital immunodeficiency associated lymphoma * No primary lymphoma of the brain * No active brain involvement or leptomeningeal disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * At least 4 months Hematopoietic: * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine no greater than 2.0 mg/dL * Calculated creatinine clearance at least 60 mL/min Cardiovascular: * No uncontrolled angina, heart failure, or arrhythmia * No acute changes on EKG Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No AIDS * Adequate nutritional status (total protein at least 60.0 g/L) * No active bacterial infections (e.g., abscess or with fistula) * No nonmalignant disease that would preclude study * No history of alcoholism, drug addiction, or psychotic disorders that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow transplantation allowed * At least 4 weeks since prior immunotherapy or cytokines Chemotherapy: * See Disease Characteristics * Prior intensive chemotherapy with stem cell support allowed * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high dose carboplatin) Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy to more than 25% of bone marrow Surgery: * Recovered from prior surgery * No prior solid organ transplantation Other: * No concurrent antiinflammatory agents including aspirin, or over the counter or prescription nonsteroidal antiinflammatory drugs * No concurrent immunosuppressive agents * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.