Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02481297
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Lirilumab — DRUG
    3 mg/kg by vein given on Day 1 of each 28 day cycle.
  • Rituximab — DRUG
    375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.

Study Details

The goal of this clinical research study is to learn if lirilumab in combination with rituximab can help to control either CLL or Small lymphocytic lymphoma (SLL). The safety of the drug combination will also be studied.

Key Dates

Start date
Jun 23, 2015
Status verified
May 2020
Primary completion
Aug 15, 2019
Completion
Aug 15, 2019

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Refractory/Relapsed After Prior Therapy
    Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
  • Experimental: Cohort 2: Untreated with High-rRisk mMolecular Features
    Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.

Primary Outcome Measure

Participants With a Response [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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