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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580228
• Other study ID #: P07714
• Secondary ID: 2011-005186-20
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2012
• Last updated: February 17, 2017
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Ghia P, Scarfò L, Perez S, Pathiraja K, Derosier M, Small K, Sisk CM, Patton N. Efficacy and safety of dinaciclib versus ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia. Blood. 2017 Jan 26. pii: blood-2016-10-748210. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Progression Free Survival		From date of randomization up to approximately 38 months
Secondary	Participant Overall Response Rate		From date of randomization up to approximately 38 months
Secondary	Participant Overall Survival Rate		From date of randomization until up to approximately 50 months