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A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphoctyic Lymphoma

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Trial Information

A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma


Inclusion Criteria:



- Must have received at least one prior therapy that includes either fludarabine or
equivalent nucleoside analogue or an alternative regimen

- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

- Women of child-bearing potential who are sexually active, ,including both female
subjects and the female sexual partners of male subjects, must agree to use a
medically accepted method of contraception prior to enrollment, while receiving
protocol-specified treatment, and for 12 months after stopping study treatment.

- 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.

- Life expectancy ≥12 weeks

Exclusion Criteria:

- Symptomatic brain metastases or primary central nervous system malignancy

- Treatment with any chemotherapy or biologic therapy within 4 weeks prior to
enrollment

- Non-hematological toxicities from prior therapy

- Presence of any serious or uncontrolled infection defined as infection requiring
hospital admission and/or parenteral antibiotics

- Known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy

- Clinically active hepatitis B or C defined as disease that requires therapy

- Women who are breast-feeding, pregnant, or intend to become pregnant

- Prior allogeneic bone marrow transplant (auto hematopoietic stem cell transplantation
[HSCT] is allowed if fully recovered)

- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer or other cancer from which the subject is considered
by his or her physician to have a 2 year survival expectation

- Any investigational drugs within 4 weeks prior to the start of treatment

- Concurrently receiving treatment in any other clinical study

- Previously treated with a cyclin dependent kinase (CDK) inhibitor (e.g., dinaciclib
or flavopiridol)

- Active autoimmune anemia or idiopathic thrombocytopenic purpura (ITP) unless stable,
defined as being responsive to corticosteroids or other standard therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants Experiencing a Dose Limiting Toxicity (DLT)

Outcome Time Frame:

Cycles 2 & 3 (Days 29-84)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P07974

NCT ID:

NCT01650727

Start Date:

October 2012

Completion Date:

August 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphoctyic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

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