A Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01650727
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dinaciclib — DRUG
    Dinaciclib is given as a single intravenous (IV) dose on Days 1, 8, and 15 in Cycle 2 through Cycle 13 (28 day cycles) at a starting dose of 7 mg/m\^2 up to a maximum dose of 14 mg/m\^2.
  • Rituximab — BIOLOGICAL
    Rituximab 375 mg/m\^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles).

Study Details

The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Key Dates

Start date
Oct 31, 2012
Status verified
Feb 2015
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

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

Arms

  • Experimental: Dinaciclib + Rituximab
    Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13.

Primary Outcome Measure

Number of Participants Experiencing a Dose Limiting Toxicity (DLT) [ Time Frame: Cycles 2 & 3 (Days 29-84) ]

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