Clinical trial NCT00868413: Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2009-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.


Eligibility criteria: 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 \</=1;
* 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.

Primary outcomes:
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.
timeFrame: 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
Secondary outcomes:
measure: Evaluate preliminary data regarding progression-free survival (PFS), tumor response rate and overall survival (OS) when ABT-263 is administered in combination with either FCR or BR.
timeFrame: Every 2 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Site Reference ID/Investigator# 17841
state: California
city: Stanford
country: United States
facility: Site Reference ID/Investigator# 25899
state: California
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 21622
state: Maryland
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 21621
state: Ohio
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 39613
state: Pennsylvania
city: Houston
country: United States
facility: Site Reference ID/Investigator# 17943
state: Texas
Study officials:
affiliation: AbbVie
name: Sari Enschede, MD
role: STUDY_DIRECTOR
References: