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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650727
• Other study ID #: P07974
• Secondary ID: 2012-001437-14MK
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2012
• Last updated: February 9, 2015
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

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.

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing a Dose Limiting Toxicity (DLT)		Cycles 2 & 3 (Days 29-84)	Yes