Clinical trial · Interventional
Combination Chemotherapy Followed By Autologous Stem Cell Transplant, and White Blood Cell Infusions in Treating Patients With Non-Hodgkin's Lymphoma
Immune Consolidation With Activated T Cells Armed With OKT3 x Rituxan (Anti-CD3 x Anti-CD20) Bispecific Antibody (CD20Bi) After Peripheral Blood Stem Cell Transplant for High Risk CD20+ Non-Hodgkin's Lymphomas
- 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, such as carmustine, etoposide, cytarabine, and melphalan work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving white blood cells, that have been treated in the laboratory with antibodies, may make the transplant work better. Giving combination chemotherapy followed by an autologous stem cell transplant, and white blood cell infusions may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of white blood cell infusions when given together with combination chemotherapy, and autologous stem cell transplant in treating patients with non-Hodgkin's lymphoma that has relapsed, is refractory, or is in remission.
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 (PBSCT) | Procedure | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT
- description
- * minus Day 8 ADMIT for Hydration * minus Day 7 Carmustine 300 mg/m2 x 1 dose * minus Day 6 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 5 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 4 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 3 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 2 Melphalan 140 mg/m2 x 1 dose * minus Day 1 Day of Rest * Day 0 Transplant
- interventionNames
- Biological: therapeutic autologous lymphocytes
- Drug: carmustine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Procedure: peripheral blood stem cell transplantation (PBSCT)
Primary outcomes (1)
- measure
- To perform a dose escalation trial of ATC armed with CD20Bi immunotherapy after PBSCT to determine the maximum tolerated dose (MTD) of ATC armed with CD20BI.
- timeFrame
- When two patienst at any dose levet have their infusion stopped due to side effects.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed CD20+ non-Hodgkin's lymphoma * Disease is refractory, relapsed, or in remission * Measurable or evaluable disease PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Hemoglobin \> 8 g/dL * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 50,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL * SGOT or SGPT ≤ 2.5 times normal * No history of severe hepatic dysfunction Renal * Creatinine ≤ 2.0 mg/dL OR * Creatinine clearance ≥ 60 mL/min * No uncompensated major adrenal dysfunction * BUN \< 1.5 times normal Cardiovascular * No severe cardiac dysfunction * No major heart disease * LVEF ≥ 50% by MUGA * No uncontrolled hypertension * No congenital or acquired heart disease or cardiac arrhythmias unless cardiac consult and evaluation are done Pulmonary * DLCO ≥ 50% of normal * No symptomatic obstructive or restrictive disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infections * HIV negative * No significant skin breakdown from tumor or other diseases * Dental evaluation and teeth cleaning with no potential sources of infection required * No uncompensated major thyroid dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy * No prior stem cell transplantation Chemotherapy * No prior total doxorubicin or daunorubicin dose ≥ 450 mg/m\^2 unless endomyocardial biopsy shows \< grade 2 drug effect AND ejection fraction ≥ 50% by gated blood pool scan Endocrine therapy * No concurrent hormonal therapy except steroids for adrenal failure, septic shock, or pulmonary toxicity or hormones for non-disease-related conditions (e.g., insulin for diabetes)
References
Publications (0)
Data not yet available