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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Interventions: Drug: Dinaciclib; Biological: Rituximab

• Registration Number: NCT01650727
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Study Start: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Must have received at least one prior therapy that includes either

fludarabine or equivalent nucleoside analogue or an alternative regimen

• Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic

lymphoma (SLL)

• Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
• Women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment.
• Women of child-bearing potential who are not currently sexually active must

agree to use a medically accepted method of contraception should they become

sexually active while participating in the study.

• Life expectancy ≥12 weeks

Exclusion Criteria

• Symptomatic brain metastases or primary central nervous system malignancy
• Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment
• Non-hematological toxicities from prior therapy
• Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics
• Known human immunodeficiency virus (HIV) infection or a known HIV-related

malignancy

• Clinically active hepatitis B or C defined as disease that requires

therapy

• Women who are breast-feeding, pregnant, or intend to become pregnant
• Prior allogeneic bone marrow transplant (auto hematopoietic stem cell

transplantation [HSCT] is allowed if fully recovered)

• Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is

considered by his or her physician to have a 2 year survival expectation

• Any investigational drugs within 4 weeks prior to the start of treatment
• Concurrently receiving treatment in any other clinical study
• Previously treated with a cyclin dependent kinase (CDK) inhibitor (e.g., dinaciclib or flavopiridol)
• Active autoimmune anemia or idiopathic thrombocytopenic purpura (ITP) unless

stable, defined as being responsive to corticosteroids or other standard therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dinaciclib + Rituximab	Rituximab	Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13.
Dinaciclib + Rituximab	Dinaciclib	Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)	Cycles 2 & 3 (Days 29-84)