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A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABT-263
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia (CLL), Navitoclax, ABT-263, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion of investigator.
  • Eastern Cooperative Oncology Group (ECOG) <= 1.
  • Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion Criteria:

  • History or is clinically suspicious for cancer-related Central Nervous System disease.
  • Receipt of allogenic or autologous stem cell transplant.
  • Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
  • Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

Sites / Locations

  • Moores Cancer Center at UC San Diego /ID# 5566
  • Dana-Farber Cancer Institute /ID# 5547
  • University of Nebraska Medical Center /ID# 12261
  • North Shore University Hospital /ID# 12267
  • University of Texas MD Anderson Cancer Center /ID# 5575
  • Northwest Medical Specialties - Tacoma /ID# 26428
  • Peter MacCallum Cancer Ctr /ID# 6583
  • The Royal Melbourne Hospital /ID# 5576
  • Universitaetsklinikum Koeln /ID# 5924
  • Leicester Royal Infirmary /ID# 15081

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Navitoclax 14/21 Day Cycle: 10 mg

Navitoclax 14/21 Day Cycle: 110 mg

Navitoclax 14/21 Day Cycle: 200 mg

Navitoclax 14/21 Day Cycle: 250 mg

Navitoclax 21/21 Day Cycle: 125 mg

Navitoclax 21/21 Day Cycle: 200 mg

Navitoclax 21/21 Day Cycle: 250 mg

Navitoclax 21/21 Day Cycle: 300 mg

Phase 2: Navitoclax 100 mg

Phase 2: Navitoclax 250 mg

Arm Description

Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.

Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.

Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.

Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.

Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.

Navitoclax 100 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).

Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).

Outcomes

Primary Outcome Measures

Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is one that: results in death, hospitalization, prolongation of hospitalization, or persistent or significant disability/incapacity; is life-threatening, a congenital anomaly, or other important medical event. Events were graded as 1=mild, 2=moderate, 3=severe, 4=life-threatening, or 5=death. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A treatment-emergent adverse event is defined as any adverse event with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug administration. Deaths category included non treatment emergent deaths.
Phase 1: Number of Participants With DLTs in the Dose Escalation Phase
DLTs were graded according to NCI CTCAE version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (< 25,000/mm^3); platelet counts < 25,000/mm^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of > 1 week.
Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase
The MTD was defined as the dose at which 30% of participants experienced a DLT during the first cycle. DLTs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (< 25,000/mm^3); platelet counts < 25,000/mm^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of > 1 week.
Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase
The RPTD was determined based on observed DLTs and/or determination of the MTD in phase 1. (See Outcome Measures 2 and 3 above for definition of DLT and MTD.)
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax
Phase 1: Maximum Observed Plasma Concentration (Cmax)
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8)
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24)
The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14.
Phase 1: Cmax/Dose
Phase 1: AUC8/Dose
Phase 1: AUC24/Dose
The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14.
Phase 1: Terminal Phase Elimination Rate Constant (β) for Navitoclax
Phase 1: Terminal Phase Elimination Half-life (t1/2) of Navitoclax
For t1/2, the harmonic mean and psuedo-standard deviation are used.
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is one that: results in death, hospitalization, prolongation of hospitalization, or persistent or significant disability/incapacity; is life-threatening, a congenital anomaly, or other important medical event. Events were graded as 1=mild, 2=moderate, 3=severe, 4=life-threatening, or 5=death. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A treatment-emergent adverse event is defined as any adverse event with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug administration. Deaths category included non treatment emergent deaths.
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing

Secondary Outcome Measures

Full Information

First Posted
May 30, 2007
Last Updated
June 12, 2023
Sponsor
AbbVie
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00481091
Brief Title
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official Title
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2007 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia (CLL), Navitoclax, ABT-263, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navitoclax 14/21 Day Cycle: 10 mg
Arm Type
Experimental
Arm Description
Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Arm Title
Navitoclax 14/21 Day Cycle: 110 mg
Arm Type
Experimental
Arm Description
Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Arm Title
Navitoclax 14/21 Day Cycle: 200 mg
Arm Type
Experimental
Arm Description
Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Arm Title
Navitoclax 14/21 Day Cycle: 250 mg
Arm Type
Experimental
Arm Description
Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Arm Title
Navitoclax 21/21 Day Cycle: 125 mg
Arm Type
Experimental
Arm Description
Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.
Arm Title
Navitoclax 21/21 Day Cycle: 200 mg
Arm Type
Experimental
Arm Description
Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.
Arm Title
Navitoclax 21/21 Day Cycle: 250 mg
Arm Type
Experimental
Arm Description
Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.
Arm Title
Navitoclax 21/21 Day Cycle: 300 mg
Arm Type
Experimental
Arm Description
Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Arm Title
Phase 2: Navitoclax 100 mg
Arm Type
Experimental
Arm Description
Navitoclax 100 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Arm Title
Phase 2: Navitoclax 250 mg
Arm Type
Experimental
Arm Description
Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Intervention Type
Drug
Intervention Name(s)
ABT-263
Other Intervention Name(s)
Navitoclax
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
Description
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is one that: results in death, hospitalization, prolongation of hospitalization, or persistent or significant disability/incapacity; is life-threatening, a congenital anomaly, or other important medical event. Events were graded as 1=mild, 2=moderate, 3=severe, 4=life-threatening, or 5=death. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A treatment-emergent adverse event is defined as any adverse event with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug administration. Deaths category included non treatment emergent deaths.
Time Frame
From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles.
Title
Phase 1: Number of Participants With DLTs in the Dose Escalation Phase
Description
DLTs were graded according to NCI CTCAE version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (< 25,000/mm^3); platelet counts < 25,000/mm^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of > 1 week.
Time Frame
Cycle 1 (Up to 21 days) plus 7 days
Title
Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase
Description
The MTD was defined as the dose at which 30% of participants experienced a DLT during the first cycle. DLTs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (< 25,000/mm^3); platelet counts < 25,000/mm^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of > 1 week.
Time Frame
Cycle 1 (Up to 21 days) plus 7 days
Title
Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase
Description
The RPTD was determined based on observed DLTs and/or determination of the MTD in phase 1. (See Outcome Measures 2 and 3 above for definition of DLT and MTD.)
Time Frame
Cycle 1 (Up to 21 days) plus 7 days
Title
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax
Time Frame
Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 1: Maximum Observed Plasma Concentration (Cmax)
Time Frame
Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8)
Time Frame
Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24)
Description
The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14.
Time Frame
Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8
Title
Phase 1: Cmax/Dose
Time Frame
Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 1: AUC8/Dose
Time Frame
Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 1: AUC24/Dose
Description
The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14.
Time Frame
Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8
Title
Phase 1: Terminal Phase Elimination Rate Constant (β) for Navitoclax
Time Frame
Cycle 1 Day 1: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 1: Terminal Phase Elimination Half-life (t1/2) of Navitoclax
Description
For t1/2, the harmonic mean and psuedo-standard deviation are used.
Time Frame
Cycle 1 Day 1: pre-dose, 2, 4, 6, 8 hours post-dose
Title
Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs
Description
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is one that: results in death, hospitalization, prolongation of hospitalization, or persistent or significant disability/incapacity; is life-threatening, a congenital anomaly, or other important medical event. Events were graded as 1=mild, 2=moderate, 3=severe, 4=life-threatening, or 5=death. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A treatment-emergent adverse event is defined as any adverse event with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug administration. Deaths category included non treatment emergent deaths.
Time Frame
From first dose of study drug to 30 days post-last dose. Participants enrolled in Phase 2 received a mean of 15.6 treatment cycles.
Title
Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing
Time Frame
Cycle 1 Day 1: 4-8 h postdose; Cycle 1 Day 15: predose; Cycle 3 Day 1: predose, 4-8 h postdose; Cycle 5 Day 1: predose, 4-8 h postdose; Cycle 7 Day 1: predose, 4-8 h postdose; Cycle 9 Day 1: predose, 4-8 h postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory CLL and require treatment in opinion of investigator. Eastern Cooperative Oncology Group (ECOG) <= 1. Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria. Exclusion Criteria: History or is clinically suspicious for cancer-related Central Nervous System disease. Receipt of allogenic or autologous stem cell transplant. Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis. Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Moores Cancer Center at UC San Diego /ID# 5566
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 5547
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Nebraska Medical Center /ID# 12261
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
North Shore University Hospital /ID# 12267
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 5575
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Medical Specialties - Tacoma /ID# 26428
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Peter MacCallum Cancer Ctr /ID# 6583
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 5576
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Universitaetsklinikum Koeln /ID# 5924
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Leicester Royal Infirmary /ID# 15081
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
22184378
Citation
Roberts AW, Seymour JF, Brown JR, Wierda WG, Kipps TJ, Khaw SL, Carney DA, He SZ, Huang DC, Xiong H, Cui Y, Busman TA, McKeegan EM, Krivoshik AP, Enschede SH, Humerickhouse R. Substantial susceptibility of chronic lymphocytic leukemia to BCL2 inhibition: results of a phase I study of navitoclax in patients with relapsed or refractory disease. J Clin Oncol. 2012 Feb 10;30(5):488-96. doi: 10.1200/JCO.2011.34.7898. Epub 2011 Dec 19.
Results Reference
result
Links:
URL
https://www.abbvieclinicaltrials.com/
Description
Related Info

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A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

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