Urelumab (CD137 mAb) With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02420938
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22) then the day prior to each subsequent dose of Urelumab for the 12-week course.
  • Urelumab — DRUG
    8 mg by vein given every 3 weeks for 4 doses, starting Day 2 of the 12-week course.

Study Details

The goal of this clinical research study is to learn if urelumab given in combination with rituximab can help to control CLL or SLL. The safety of the drug combination will also be studied.

Key Dates

Start date
Jul 31, 2015
Status verified
Dec 2016
Primary completion
Jul 31, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + Urelumab
    Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22) then the day prior to each subsequent dose of Urelumab for the 12-week course. Urelumab 8 mg by vein given every 3 weeks for 4 doses, starting Day 2 of the course. Urelumab doses administered approximately 24 hours after the Rituximab doses. Up to two 12-week courses of treatment administered (total of maximum 12 doses of Rituximab and 8 doses of Urelumab).

Primary Outcome Measure

Overall Response (OR) of Urelumab and Rituximab in Participants with High-Risk Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL). [ Time Frame: 12 weeks ]

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