Risk Adapted Therapy in Diffuse Large B Cell Lymphoma

Sponsor
Mansoura University
Study ID
NCT03188198
Phase
PHASE2
Status
Unknown

Conditions

  • Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.

Key Dates

Start date
Jun 1, 2016
Status verified
Jun 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2019

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A - R-CHOP
    Patients receive the following treatment:Rituximab 375 mg/m2 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. Interventions:-Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: filgrastim-Drug: pegfilgrastim
  • 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) Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6. Interventions: -Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: etoposide-Drug: filgrastim

Primary Outcome Measure

Response rate [ Time Frame: one year post-registration ]

Central Contacts

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