Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
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).
Interventions
DRUGDinaciclib
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.
BIOLOGICALRituximab
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).
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing a Dose Limiting Toxicity (DLT) | Cycles 2 & 3 (Days 29-84) |
Outcome results
None listed