Back to resultsA Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)
Primary Purpose
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dinaciclib
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dinaciclib + Rituximab
Arm Description
Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Secondary Outcome Measures
Full Information
NCT ID
NCT01650727
First Posted
July 24, 2012
Last Updated
February 9, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01650727
Brief Title
A Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dinaciclib + Rituximab
Arm Type
Experimental
Arm Description
Rituximab will be administered in Cycles 1 and 3-13.
Dinaciclib will be administered in Cycles 2-13.
Intervention Type
Drug
Intervention Name(s)
Dinaciclib
Other Intervention Name(s)
SCH 727965, MK-7965
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan®
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Time Frame
Cycles 2 & 3 (Days 29-84)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
25217392
Citation
Fabre C, Gobbi M, Ezzili C, Zoubir M, Sablin MP, Small K, Im E, Shinwari N, Zhang D, Zhou H, Le Tourneau C. Clinical study of the novel cyclin-dependent kinase inhibitor dinaciclib in combination with rituximab in relapsed/refractory chronic lymphocytic leukemia patients. Cancer Chemother Pharmacol. 2014 Nov;74(5):1057-64. doi: 10.1007/s00280-014-2583-9. Epub 2014 Sep 13.
Results Reference
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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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