Phase 3 N=695 Randomized Treatment

Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00278408 ↗

Enrolled (actual)

695

Serious AEs

25.2%

Results posted

Aug 2025

Primary outcome: Primary: 3 Years Event-free Survival — 51; 56; 126; 123 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: filgrastim (Biological); rituximab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); prednisone (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)
Age: Adult · 18+ yrs
Sex: All
Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 3 Years Event-free Survival	51; 56; 126; 123; 89; 92	—
SECONDARY 3 Years Progression-free Survival	64; 68; 133; 136; 96; 104	—
SECONDARY 3 Years Overall Survival	76; 74; 144; 141; 107; 108	—
SECONDARY Rate of Complete Remissions and Progressive Disease	64; 64; 141; 133; 109; 105	—
SECONDARY Number of Patients With a Relapse After a CR/CRu	12; 8; 13; 9; 18; 7	—
SECONDARY Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin)	4; 1; 7; 4; 8; 8	—
SECONDARY Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median)	12; 12; 12; 12; 12; 12	—
SECONDARY Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion	21; 25; 42; 39; 22; 36	—
SECONDARY Adherence to Protocol - Total Duration of Chemotherapy in Days (Median)	105; 70; 105; 71; 105; 70	—
SECONDARY Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median)	4474; 4482; 4464; 4474; 4476; 4455	—

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
Grade 3 follicular lymphoma
Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
Centroblastic
Immunoblastic
Plasmablastic
Anaplastic large cell
T-cell-rich B-cell lymphoma
Primary effusion lymphoma
Intravascular B-cell lymphoma
Primary mediastinal B-cell lymphoma
Burkitt's or Burkitt-like lymphoma
Mantle cell lymphoma (blastoid)
Aggressive marginal zone lymphoma (monocytoid)
Previously untreated disease
CD20-positive disease
International prognostic index (IPI) score 0 or 1 (age-adjusted)
Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
No mucosa-associated lymphoid tissue (MALT) lymphoma
No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Platelet count ≥ 100,000/mm³
WBC ≥ 2,500/mm³
No known hypersensitivity to the study medications
No known HIV-positivity
No active hepatitis infection
Not pregnant or lactating
Negative pregnancy test
No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
No impaired left ventricular function
No severe cardiac arrhythmias
No other impaired organ function
No other serious disorder

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy
No prior immunosuppressive treatment with cytostatics
No concurrent participation in other treatment studies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00278408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.