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

NCT01580228 | Completed Phase 3 DMC

• 2 other identifiers: P077142011-005186-20
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Outcome Measures

Primary Outcomes (1)

• Participant Progression Free Survival

  From date of randomization up to approximately 38 months

Secondary Outcomes (2)

• Participant Overall Response Rate

  From date of randomization up to approximately 38 months

• Participant Overall Survival Rate

  From date of randomization until up to approximately 50 months

Study Arms (2)

Dinaciclib

EXPERIMENTAL

Drug: Dinaciclib

Ofatumumab

ACTIVE COMPARATOR

Drug: Ofatumumab

Interventions

Dinaciclib 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.

Also known as: SCH-727965, MK-7965

Dinaciclib

Ofatumumab 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.

Also known as: Arzerra

Ofatumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 28126927 RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

dinaciclib; ofatumumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 18, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02