Clinical trial · Interventional
Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma
Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab
NCT00064116CI-TRIAL-00044387IDEC-C2B8completedPhase 3ClinicalTrials.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: 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. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP regimen | Drug | CHOP Regimen | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: CHOP-21
- description
- Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6
- interventionNames
- Drug: CHOP regimen
- type
- ACTIVE_COMPARATOR
- label
- Arm B: CHOP-21 + Rituximab
- description
- Rituximab 375 mg/m² i.v. day 1\* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6
- interventionNames
- Biological: rituximab
- Drug: CHOP regimen
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification
* Diagnosed within the past 6 weeks
* CD20+ disease
* Ann Arbor stage II, III, or IV disease or stage I bulky disease
* International Prognostic Index (IPI) score of 0 or 1
* Score 0 defined by all of the following:
* Stage I or II disease
* ECOG performance status of 0 or 1
* Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)
* Score 1 defined by 1 of the following:
* Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN
* Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN
* Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN
* Previously untreated disease
* Mediastinal B-cell lymphoma allowed
* No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies
* No transformed lymphoma
* No primary CNS lymphoma
* No primary gastrointestinal (MALT) lymphoma
* No post-transplant lymphoproliferative disorder
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Performance status
* See Disease Characteristics
* ECOG 0-3
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 2.0 mg/dL\*
* Transaminases no greater than 3 times normal\*
* No active chronic hepatitis B or C infection NOTE: \*Unless related to lymphoma
Renal
* Creatinine no greater than 2 times normal\* NOTE: \*Unless related to lymphoma
Cardiovascular
* No myocardial infarction within the past 6 months
* No uncompensated heart failure
* No dilatative cardiomyopathy
* No coronary heart disease with ST segment depression on ECG
* No severe uncompensated hypertension
Pulmonary
* No chronic lung disease with hypoxemia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No known allergic reactions against foreign proteins
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No concurrent disease that would preclude study treatment
* No active infections requiring systemic antibiotics or antiviral medications
* No severe uncompensated diabetes mellitus
* No clinical signs of cerebral dysfunction
* No severe psychiatric disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior murine antibodies
Chemotherapy
* No other concurrent anticancer chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy
Surgery
* Not specified
Other
* No prior lymphoma-specific treatment
* More than 12 weeks since prior participation in another clinical trial
* No prior participation in this study
* No other concurrent study medicationReferences
Publications (2)
- RESULTPfreundschuh M, Ho AD, Cavallin-Stahl E, Wolf M, Pettengell R, Vasova I, Belch A, Walewski J, Zinzani PL, Mingrone W, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Corrado C, Scheliga A, Loeffler M, Kuhnt E; MabThera International Trial (MInT) Group. Prognostic significance of maximum tumour (bulk) diameter in young patients with good-prognosis diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an exploratory analysis of the MabThera International Trial Group (MInT) study. Lancet Oncol. 2008 May;9(5):435-44. doi: 10.1016/S1470-2045(08)70078-0. Epub 2008 Apr 8. PMID 18400558
- RESULTPfreundschuh M, Trumper L, Osterborg A, Pettengell R, Trneny M, Imrie K, Ma D, Gill D, Walewski J, Zinzani PL, Stahel R, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Lehtinen T, Lopez-Guillermo A, Corrado C, Scheliga A, Milpied N, Mendila M, Rashford M, Kuhnt E, Loeffler M; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91. doi: 10.1016/S1470-2045(06)70664-7. PMID 16648042