Clinical trial · Interventional
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and 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 giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with 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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
- description
- Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy.
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- Drug: carboplatin
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: ifosfamide
- Drug: prednisone
- Drug: vincristine sulfate
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 2 years
- description
- Kaplan-Meier estimates will be used to verify the progression free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive diffuse large B-cell lymphoma * CD20-positive disease * Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following: * Karnofsky performance status 10-70% * Lactate dehydrogenase greater than 200 U/L * Stage III or IV disease * Positron emission tomography avid measurable disease * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 64 Performance status: * See Disease Characteristics Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease * Hepatitis B surface antigen and hepatitis C antibody negative * No chronic, active, or persistent hepatitis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * No chronic renal insufficiency Cardiovascular: * Ejection fraction at least 50% by echocardiogram or MUGA scan * No myocardial infarction within the past 6 months * No unstable angina * No cardiac arrhythmias except chronic atrial fibrillation Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * HIV negative * No other medical illness that would preclude study * No uncontrolled infection * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for malignancy Chemotherapy: * No prior chemotherapy for malignancy Endocrine therapy: * Prior steroids allowed if received no more than 1 week of therapy Radiotherapy: * No prior radiotherapy for malignancy Surgery: * No prior surgery for malignancy Other: * No other prior therapy for malignancy
References
Publications (1)
- DERIVEDBantilan KS, Smith AN, Maurer MJ, Teruya-Feldstein J, Matasar MJ, Moskowitz AJ, Straus DJ, Noy A, Palomba ML, Horwitz SM, Hamlin PA, Portlock CS, Cerhan JR, Habermann TM, Salles GA, Nowakowski GS, Moskowitz CH, Zelenetz AD. Matched control analysis suggests that R-CHOP followed by (R)-ICE may improve outcome in non-GCB DLBCL compared with R-CHOP. Blood Adv. 2024 May 14;8(9):2172-2181. doi: 10.1182/bloodadvances.2023011408. PMID 38271621