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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia (CLL)

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Progression Free Survival

Outcome Time Frame:

From date of randomization up to approximately 38 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P07714

NCT ID:

NCT01580228

Start Date:

August 2012

Completion Date:

April 2016

Related Keywords:

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

Name

Location

Call for Information (Investigational Site 0035) Canton, Ohio  44718
Call for Information (Investigational Site 0006) Fort Collins, Colorado  80615
Call for Information (Investigational Site 0268) Chicago, Illinois  60637
Call for Information (Investigational Site 0003) Billings, Montana  59101
Call for Information (Investigational Site 0007) Hackensack, New Jersey  07601
Call for Information (Investigational Site 0265) Bronx, New York  10461
Call for Information (Investigational Site 0101) Portland, Oregon  97225
Call for Information (Investigational Site 0144) Portland, Oregon  97213
Call for Information (Investigational Site 0048) Sayre, Pennsylvania  18840
Call for Information (Investigational Site 0118) Dallas, Texas  75390
Call for Information (Investigational Site 0269) Temple, Texas  76508