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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01650727
First received: July 24, 2012
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Dinaciclib
Biological: Rituximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing a Dose Limiting Toxicity (DLT) [ Time Frame: Cycles 2 & 3 (Days 29-84) ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01650727     History of Changes
Other Study ID Numbers: P07974, 2012-001437-14, MK-7965-011
Study First Received: July 24, 2012
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014