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

Conditions

• Large B Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  IV
• cyclophosphamide — DRUG
  IV
• doxorubicin — DRUG
  IV or CIVI
• vincristine — DRUG
  IV or CIVI
• prednisone — DRUG
  oral
• etoposide — DRUG
  CIVI
• filgrastim — DRUG
  IV
• pegfilgrastim — DRUG
  IV

Study Details

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.

Key Dates

Start date

May 31, 2005

Status verified

Nov 2021

Primary completion

Oct 31, 2017

Completion

Nov 15, 2021

Study Design

Enrollment

524 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A - R-CHOP
  Patients receive the following treatment: * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy * Cyclophosphamide 750 mg/m\^2 IV on Day 1 * Doxorubicin 50 mg/m\^2 IV on Day 1 * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1 * Prednisone 40 mg/m\^2/day PO on Days 1-5 * filgrastim or pegfilgrastim as defined in the protocol Required ancillary medications is administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
• Experimental: Arm B - DA-EPOCH-R
  Patients receive the following treatment: Cycle 1 Doses: * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4 * Etoposide 50 mg/m\^2/day CIVI on Days 1-4 * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours) * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions) * Prednisone 60 mg/m\^2 PO BID on Days 1-5 * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not being monitored, during every cycle. Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Required ancillary medications are administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.

Primary Outcome Measure

Progression-Free Survival Rate at 2 and 5 Years [ Time Frame: Up to 5 years post-registration ]

Locations (47)

Find similar trials in La Jolla, CA

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