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

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ClinicalTrials.gov Identifier: NCT01650727
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Dinaciclib Biological: Rituximab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Study Start Date : October 2012
Primary Completion Date : October 2013
Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Dinaciclib + Rituximab

Rituximab will be administered in Cycles 1 and 3-13.

Dinaciclib will be administered in Cycles 2-13.

Drug: Dinaciclib
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.
Other Names:
  • SCH 727965
  • MK-7965
Biological: Rituximab
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).
Other Name: Rituxan®

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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


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


  • 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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01650727     History of Changes
Other Study ID Numbers: P07974
2012-001437-14 ( EudraCT Number )
MK-7965-011 ( Other Identifier: Merck Study Number )
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents