Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma

Conditions

• Contiguous Stage II Adult Diffuse Large Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
• Stage I Adult Diffuse Large Cell Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carfilzomib — DRUG
  Given IV, according to dose level. Cohorts begin with dose level (DL)1, escalated in standard 3+3 design to identify a recommended phase 2 dose DL (-2) 11 mg/m2 on day 1 and 2 every 21 days, cycles 1-6 DL (-1) 15 mg/m2 on days 1 and 2 every 21 days, cycles 1-6 DL (1) 20 mg/m2 days 1,2 every 21 days, cycles 1-6 DL (2) 20 mg/m2 days 1,2 of cycle 1 followed by 27 mg/m2 days 1,2 every 21 days for cycles 2-6. DL (3) 20 mg/m2 days 1,2 of cycle 1 followed by 36 mg/m2 days 1,2 every 21 days for cycles 2-6. DL(4) 20 mg/m2 days 1,2 of cycle 1 followed by 45 mg/m2 days 1,2 every 21 days for cycles 2-6 DL (5) 20 mg/m2 days 1,2 of cycle 1 followed by 56 mg/m2 days 1,2 every 21 days for cycles 2-6
• Rituximab — BIOLOGICAL
  Given IV (375mg/m\^2)
• Cyclophosphamide — DRUG
  Given IV (750mg/m\^2)
• Doxorubicin hydrochloride — DRUG
  Given IV (50mg/m\^2)
• Vincristine sulfate — DRUG
  Given IV (1.4mg/m\^2)
• Prednisone — DRUG
  Given PO (100mg)
• Pegfilgrastim — DRUG
  6 mg SC day 4 (every 21 days). Filgrastim 300 or 480 mcg IV/SC daily days 1-10 may be substituted if pegfilgrastim is not available. ONPROTM is also an acceptable method of administration.
• Acyclovir — DRUG
  PO (400mg)

Study Details

This phase I/II trial studies the side effects and best dose of carfilzomib when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with diffuse large B-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth by finding cancer cells and helping kill them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not known if carfilzomib in combination with R-CHOP is better or worse than R-CHOP alone in treating patients with diffuse large b-cell lymphoma.

Key Dates

Start date

Jan 28, 2015

Status verified

May 2024

Primary completion

Jul 20, 2021

Completion

Jun 29, 2023

Study Design

Enrollment

48 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: rituximab, combination chemotherapy, carfilzomib
  Participants receive (every 21 day cycle): * Rituximab IV over at least 90 minutes on day 2 * Carfilzomib IV over 30 minutes on days 1, and 2 * Cyclophosphamide IV over 30-60 minutes on day 3 * Doxorubicin hydrochloride IV over 3-5 minutes on day 3 * Vincristine sulfate IV over 1 minute on day 3 * Prednisone PO on days 3-7 any time * Pegfilgrastim day 4 * Acyclovir 2x per day from cycle 1, 6 months after completion of cycle 6 Courses repeat every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended Phase II Dose (Phase I) [ Time Frame: Through cycle 6 (each cycle is 21 days) ]

Locations (3)

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