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

Primary Purpose

Chronic Lymphocytic Leukemia (CLL)

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Dinaciclib

Ofatumumab

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dinaciclib

Ofatumumab

Arm Description

Outcomes

Primary Outcome Measures

Participant Progression Free Survival

Secondary Outcome Measures

Participant Overall Response Rate

Participant Overall Survival Rate

Full Information

NCT ID

NCT01580228

First Posted

April 3, 2012

Last Updated

February 17, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01580228

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia (CLL)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dinaciclib

Arm Type

Experimental

Arm Title

Ofatumumab

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Dinaciclib

Other Intervention Name(s)

SCH-727965, MK-7965

Intervention Description

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

Intervention Name(s)

Ofatumumab

Other Intervention Name(s)

Arzerra

Intervention Description

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.

Primary Outcome Measure Information:

Title

Participant Progression Free Survival

Time Frame

From date of randomization up to approximately 38 months

Secondary Outcome Measure Information:

Title

Participant Overall Response Rate

Time Frame

From date of randomization up to approximately 38 months

Title

Participant Overall Survival Rate

Time Frame

From date of randomization until up to approximately 50 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

28126927

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.

Results Reference

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

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