Phase 3 N=524 Randomized Treatment

Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Large B Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00118209 ↗

Enrolled (actual)

524

Serious AEs

92.9%

Results posted

Apr 2020

Primary outcome: Primary: Progression-Free Survival Rate at 2 and 5 Years — 78.9; 75.5; 68.0; 66.0 percentage of participants — p=0.6519

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rituximab (Biological); cyclophosphamide (Drug); doxorubicin (Drug); vincristine (Drug); prednisone (Drug); etoposide (Drug); filgrastim (Drug); pegfilgrastim (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival Rate at 2 and 5 Years	78.9; 75.5; 68.0; 66.0	0.6519
SECONDARY Response Rate	86.7; 88.0	0.67
SECONDARY Overall Survival Rate at 2 and 5 Years	86.5; 85.7; 77.5; 78.5	0.6414

Summary

This randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.

Eligibility Criteria

Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease.
Stage I primary mediastinal (thymic) DLBCL is also eligible.
Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible.
Diagnosis should be based on an adequate tissue sample, including open biopsy or core needle biopsy.
Needle aspiration for primary diagnosis is unacceptable.
Patients must have one of the following WHO classification subtypes:
Diffuse large B-cell lymphoma (includes morphological variants: centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic)
Mediastinal (thymic) large B-cell lymphoma
Intravascular large B-cell lymphoma
Note: Failure to submit a pathology block within 60 days of patient registration will be considered a major protocol violation.
Fresh (frozen) tumor biopsy must be available or attempted. A frozen tumor biopsy equivalent to a minimum of four at least 16 gauge needle cores is an important component of this study.
Patients without adequate frozen material should have a biopsy performed to obtain material.
If a biopsy is performed and does not yield adequate material, the patient is still eligible for the study. If a biopsy cannot be done safely, the patient may still be eligible for the study if permission is granted.
Note: This study does not allow concurrent radiation unless a patient has a documented CNS treatment failure with no systemic failure.
No prior cytotoxic chemotherapy or rituximab. Patients may be entered if they have received prior limited field radiation therapy or a short course of glucocorticoids ( 45%, but the study is not required
No known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not required in the absence of neurological symptoms
No known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible.
Non pregnant and non-nursing. Treatment would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective form of contraception.
Patients with active medical processes (e.g., uncontrolled bacterial or viral infection, bleeding) not related to their lymphoma should be excluded.
Required Initial Laboratory Values (unless non-Hodgkin lymphoma):
ANC ≥ 1000/μL
Platelets ≥ 100,000/μL
Creatinine≤ 1.5 mg/dL or creatinine clearance ≥ 50 cc/min
Total Bilirubin ≤ 2 mg/dL (unless a history of Gilbert's Disease)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00118209). 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.