Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Conditions

• Diffuse, Large B-Cell, Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  375 mg/m2 IV

Study Details

The use of R-CHOP, given every two weeks, will be associated with improvements in response rate, and progression-free survival, when compared to R-CHOP given every three weeks. The addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP, while at the same time, improving the functional capability of the macrophages, and thus increasing the likelihood of improved clinical response and disease-free survival. The current phase II study is being proposed in order to develop preliminary data on the efficacy and toxicity of this approach, for future study in larger, phase III randomized trials. Laboratory correlates of response will also be studied, including activation markers on monocytes/macrophages before and after sargramostim exposure; and presence or absence of informative Fc gamma III polymorphisms.

Key Dates

Start date

Jan 10, 2008

Status verified

Nov 2021

Primary completion

Jan 10, 2020

Completion

Jan 10, 2021

Study Design

Enrollment

52 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Rituximab 375 mg/m2 iv on day 1 q 15 days just prior to CHOP, beginning with cycle 1.

Primary Outcome Measure

The primary endpoint in this trial will be tumor complete response (CR, CRu) to R-CHOP + GM-CSF, given every 14 days [ Time Frame: Every 2 cycles ]

Locations (1)

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