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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Conditions
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Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment
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* Drug: Dinaciclib
* Biological: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dinaciclib + Rituximab<br>Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13. | Drug: Dinaciclib<br>* 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.<br>* Other names: MK-7965;Biological: Rituximab<br>* 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).<br>* Other names: Rituxan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing a Dose Limiting Toxicity (DLT) |  | Cycles 2 & 3 (Days 29-84) |