Clinical trial · Interventional
Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Non-Hodgkin's Lymphoma
BEAM Plus Iodine-131 Anti-B1 Antibody and Autologous Hematopoietic Stem Cell Transplantation for Treatment of Recurrent Diffuse Large B-Cell 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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tositumomab and iodine I 131 tositumomab | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Iodine-131 Anti-B1 Antibody/BEAM/autologous hematopoietic stem cell transplantation (AHSCT)
- interventionNames
- Drug: carmustine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Procedure: peripheral blood stem cell transplantation
- Radiation: tositumomab and iodine I 131 tositumomab
Primary outcomes (1)
- measure
- Event free survival rate
- timeFrame
- 100 days post transplant and at yearly intervals
- description
- Participant survival without adverse events or progression
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types: * Diffuse large B-cell * Composite (at least 50% of tumor showing diffuse histology) * Diffuse mixed cell * Immunoblastic * Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response) * Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation * Evidence of CD20 antigen expression in tumor tissue * Bidimensionally measurable disease * Adequate peripheral blood stem cells * At least 15,000,000 CD34+ cells/kg or * At least 25,000 granulocyte macrophage colony-forming units/kg * Age: 19 to 70 * Performance status: Karnofsky 70-100% * Life expectancy: at least 4 months post-transplantation * Bilirubin less than 2.0 mg/dL * Creatinine less than 2.0 mg/dL * Cardiac ejection fraction at least 40% for any of the following criteria: * Age 60 and over * Significant cardiac history (myocardial infarction or congestive heart failure) * Received greater than 350 mg/m\^2 of prior doxorubicin * DLCO at least 50% of predicted * HIV negative * Fertile patients must use effective contraception during and for at least 6 months after study participation * At least 4 weeks since prior biologic therapy and recovered * Human antimouse antibody negative * At least 4 weeks since prior cytotoxic chemotherapy and recovered * At least 4 weeks since prior radiotherapy and recovered * At least 4 weeks since prior immunosuppressants and recovered Exclusion Criteria: * No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year * No known brain or leptomeningeal metastases * No active obstructive hydronephrosis * No New York Heart Association class III or IV heart disease * No evidence of severe organ dysfunction * No other major medical illnesses * No active infection requiring IV antibiotics * No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix * Not pregnant/negative pregnancy test * No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy * No other concurrent biologic therapy for NHL * No concurrent steroids except maintenance-dose steroids for noncancerous disease * No concurrent external beam radiotherapy for NHL * No other concurrent participation on protocol involving non-FDA-approved drugs or biologics
References
Publications (0)
Data not yet available