A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

NCT ID: NCT01580228

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-12-31

Brief Summary

This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

Detailed Description

Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dinaciclib

Group Type: EXPERIMENTAL

Dinaciclib

Intervention Type: DRUG

Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m\^2 on Day 1, 10 mg/m\^2 on Day 8, and 14 mg/m\^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles.

Ofatumumab

Group Type: ACTIVE_COMPARATOR

Ofatumumab

Intervention Type: DRUG

Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12.

Interventions

Dinaciclib

Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m\^2 on Day 1, 10 mg/m\^2 on Day 8, and 14 mg/m\^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles.

Intervention Type: DRUG

Ofatumumab

Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12.

Intervention Type: DRUG

Other Intervention Names

SCH-727965; MK-7965; Arzerra

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older
• Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
• Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody
• Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2
• Adequate organ function and laboratory parameters
• 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

Exclusion Criteria

• Symptomatic brain metastases or primary central nervous system malignancy
• Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization
• Known human immunodeficiency virus (HIV) infection or a known HIV-related

malignancy

• Participants with with clinically active hepatitis B or C defined as disease that requires therapy
• Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency
• Prior allogeneic bone marrow transplant
• Presence of Richter's transformation
• Indeterminate deletion 17p status
• Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors
• Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Ghia P, Scarfo L, Perez S, Pathiraja K, Derosier M, Small K, McCrary Sisk C, Patton N. Efficacy and safety of dinaciclib vs ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia. Blood. 2017 Mar 30;129(13):1876-1878. doi: 10.1182/blood-2016-10-748210. Epub 2017 Jan 26. No abstract available.

Reference Type: RESULT

PMID: 28126927 (View on PubMed)

Other Identifiers

2011-005186-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P07714

Identifier Type: -

Identifier Source: org_study_id