Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

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AbbVie

Status and phase

Completed
Phase 1

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: BR
Drug: FCR
Drug: ABT-263

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868413
M10-458

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

A
Active Comparator group
Description:
FCR+ABT-263
Treatment:
Drug: ABT-263
Drug: FCR
B
Active Comparator group
Description:
BR+ABT-263
Treatment:
Drug: ABT-263
Drug: BR

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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