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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia

Treatments

Biological: Rituximab

Drug: Dinaciclib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01650727

MK-7965-011 (Other Identifier)

2012-001437-14 (EudraCT Number)

P07974

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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