Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Genentech
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00868413
First received: March 20, 2009
Last updated: March 5, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: ABT-263 Drug: FCR Drug: BR |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Bendamustine hydrochloride
Bendamustine
Fludarabine
Fludarabine phosphate
Rituximab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- 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. [ 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]Tumor assessments
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
FCR+ABT-263
|
Drug: ABT-263
ABT-263 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Other Name: ABT-263
Drug: FCR
Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle; Fludarabine will be given by intravenous infusion for 3 days out of each 28 day cycle; and Cyclophosphamide will be given by intravenous infusion for 3 days out of each 28 day cycle
Other Name: fludarabine, cyclophosphamide, rituximab
|
|
Active Comparator: B
BR+ABT-263
|
Drug: ABT-263
ABT-263 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Other Name: ABT-263
Drug: BR
Rituximab will be given by intravenous infusion for 2 days out of each 28 day cycle and Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle
Other Name: bendamustine, rituximab
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868413
Locations
| United States, California | |
| Site Reference ID/Investigator# 17841 | |
| La Jolla, California, United States, 92093 | |
| Site Reference ID/Investigator# 25899 | |
| Stanford, California, United States, 94305-5821 | |
| United States, Maryland | |
| Site Reference ID/Investigator# 21622 | |
| Baltimore, Maryland, United States, 21231-1000 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 21621 | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Site Reference ID/Investigator# 39613 | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Texas | |
| Site Reference ID/Investigator# 17943 | |
| Houston, Texas, United States, 77030-4009 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech
Investigators
| Study Director: | Sari Enschede, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00868413 History of Changes |
| Other Study ID Numbers: | M10-458 |
| Study First Received: | March 20, 2009 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Fludarabine monophosphate Rituximab Nitrogen Mustard Compounds Bendamustine |
Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013