Clinical trial NCT01580228: A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia (CLL)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant Progression Free Survival
timeFrame: From date of randomization up to approximately 38 months
Secondary outcomes:
measure: Participant Overall Response Rate
timeFrame: From date of randomization up to approximately 38 months
measure: Participant Overall Survival Rate
timeFrame: From date of randomization until up to approximately 50 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.