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A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Must have relapsed or refractory Chronic Lymphocytic Leukemia (CLL), received no more
than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for
treatment with either Fludarabine/Cyclophosphamide/Rituximab (FCR) or
Bendamustine/Rituximab (BR);

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of
- Must have adequate bone marrow independent of growth factor support (with the
exception of subjects with bone marrow heavily infiltrated with underlying disease
[80% or more] who may use growth factor support to achieve Absolute Neutrophil Count
(ANC) eligibility criteria), per local laboratory reference range at Screening as
follows: ANC >/=1000/mcL, Platelets>/= 100,000/mm3 (entry platelet count must be
independent of transfusion within 14 days of Screening),Hemoglobin >/= 9.0 g/dL.

Exclusion Criteria:

- Subject has history or is clinically suspicious for cancer-related Central Nervous
System disease;

- Has history of severe allergic or anaphylactic reactions to human, humanized,
chimeric or murine monoclonal antibodies;

- Has undergone an allogeneic stem cell transplant; Exhibits evidence of other
uncontrolled condition(s) including, but not limited to: uncontrolled systemic
infection, diagnosis of fever and neutropenia within 1 week prior to study drug
administration;

- Has underlying, predisposing condition of bleeding or currently exhibits signs of
bleeding; Has a recent history of non-chemotherapy induced thrombocytopenic
associated bleeding;

- Currently receiving or requires anticoagulation therapy;

- Has active immune thrombocytopenic purpura (ITP) or a history of being refractory to
platelet transfusions (within 1 year prior to 1st dose of study drug);

- Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL.

Outcome Time Frame:

Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days

Safety Issue:

Yes

Principal Investigator

Sari Enschede, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M10-458

NCT ID:

NCT00868413

Start Date:

November 2009

Completion Date:

May 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Site Reference ID/Investigator# 17841La Jolla, California  92093-0820
Site Reference ID/Investigator# 25899Stanford, California  94305-5821
Site Reference ID/Investigator# 21622Baltimore, Maryland  21231-1000
Site Reference ID/Investigator# 21621Columbus, Ohio  43210
Site Reference ID/Investigator# 39613Philadelphia, Pennsylvania  19111
Site Reference ID/Investigator# 17943Houston, Texas  77030-4009