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A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

Primary Purpose

Chronic Lymphoid Leukemia, Lymphoid Malignancies, Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABT-263
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphoid Leukemia focused on measuring Sezary syndrome, cutaneous T-cell lymphoma, follicular lymphoma, marginal zone lymphoma, indolent T-cell lymphoma, Navitoclax, Non-Hodgkin's lymphoma, peripheral T-cell lymphoma, ABT-263, lymphoid malignancies, chronic lymphoid leukemia, mycosis fungoides, mantle cell lymphoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnoses:

    • 1a/1b - lymphoid malignancy;
    • 2a, Arm A - follicular lymphoma;
    • 2a, Arm B - mantle cell, peripheral or cutaneous T-cell lymphomas including mycosis fungoides and Sezary syndrome or other indolent B-cell lymphomas such as marginal zone lymphoma;
  • Received at least 1 prior chemotherapy treatment regimen (P1a/1b) and relapsed or refractory disease (P2a).
  • Eastern Cooperative Oncology Group (ECOG) score of <= 1.
  • Magnetic Resonance Imaging (MRI)/computed tomography (CT) negative for subdural or epidural hematoma w/in 28 days prior to first dose, if clinically indicated.
  • Stable dose of Selective serotonin reuptake inhibitors (SSRI) antidepressants for at least 21 days prior to 1st dose.
  • Adequate bone marrow (BM) independent of any growth factor support (except with heavily infiltrated bone marrow (80% or more)):

    • Absolute Neutrophil Count (ANC) >= 1000/µL;
    • Platelets >= 100,000/mm3 (entry count must be independent of transfusion with in 14 days of Screening);
    • Hemoglobin >= 9.0/dL.
  • Adequate coagulation, renal, and hepatic function:

    • Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min;
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 x Upper Limit of Normal (ULN);
    • Bilirubin <= 1.5 x ULN;
    • Gilbert's Syndrome may have a bilirubin > 1.5 x ULN;
    • Coagulation: Activated partial thromboplastin time (aPTT), Prothrombin Time (PT), not to exceed 1.2 x ULN
  • Females must be surgically sterile, postmenopausal (at least 1 year), or negative results for a pregnancy test performed at Screening on a serum sample obtained with in 14 days prior to initial dose, and prior to dosing on a urine sample obtained on C1 D-3 (P1a) or Lead-in D1 (P1b, P2a) if > 7 days since serum results.
  • Females not surgically sterile or postmenopausal (at least 1 year) and non-vasectomized males must practice birth control.
  • P2a only: History of autologous stem cell transplant must be > 6 months post transplant with adequate BM independent of growth factor support per lab reference range at Screening as follows:

    • Absolute Neutrophil Count (ANC) >= 1,500/µL;
    • Platelets >= 125,000/mm3 (entry platelet count must be independent of transfusion with in 14 days of Screening);
    • Hemoglobin >= 10.0g/dL;
  • Measurable disease by International Working Group (IWG)/National Cancer Institute- sponsored Working Group (NCI-WG) criteria.
  • At least one of following for Pharmacodynamics (P2a):

    • archived diagnostic Formalin Fixed Paraffin Embedded (FFPE) tumor tissue with no intervening treatment since biopsy,
    • core needle biopsy of malignant lymph node, or
    • bone marrow aspirate or core positive for lymphoma.

Extension Study Inclusion Criteria Phase 2a subjects who enter the Extension Study must continue to meet all Inclusion and Exclusion criteria, with the exception of Inclusion Criterion regarding measurable disease by International Working Group (IWG)/National Cancer Institute- sponsored Working Group (NCI-WG) criteria and Inclusion Criteria regarding laboratory parameters for hematology, coagulation, and chemistry. Subjects entering the Extension Study must also have stable lab values per applicable laboratory reference ranges. In addition, subjects must also meet the following criteria:

  • Subjects must meet the following hematology and coagulation lab criteria:

    • Platelet counts must be >= 25,000/mm3 (untransfused). Platelet counts <= 50,000/mm3 must be stable and monitored at an increased frequency at the discretion of the investigator.
    • Absolute Neutrophil count (ANC) >= 500/µL. ANC >= 500/µL and < 1,000/µL should be monitored at an increased frequency at the discretion of the investigator.
    • Hemoglobin of >= 8.0 g/dL.
    • aPTT, PT is not to exceed 1.2 x ULN.
  • Chemistry values must not exceed Grade 2. Grade 2 chemistry labs should be monitored at an increased frequency at the discretion of the investigator. Subjects must meet the following chemistry criteria:

    • Serum creatinine <= 3.0 x the upper normal limit (ULN) of institution's normal range. * AST and ALT <= 5.0 x the upper normal limit (ULN) of institution's normal range.
    • Bilirubin <= 3.0 x ULN. Subjects with Gilbert's Syndrome may be allowed to have a Bilirubin > 3.0 x ULN based on a joint decision between the investigator and Abbott medical monitor.

Exclusion Criteria:

  • History of, or is, clinically suspicious for cancer-related Central Nervous System (CNS) disease, lymphoid or non-lymphoid.
  • Undergone an allogeneic or autologous stem cell transplant.
  • Underlying, predisposing condition of bleeding or currently exhibits signs of clinically significant bleeding.
  • Recent history of non-chemotherapy induced thrombocytopenic associated bleeding with in 1 year prior to first dose.
  • Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions with in 1 year prior to first dose.
  • Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
  • Females pregnant or breast-feeding.
  • Positive for human immunodeficiency virus (HIV)
  • History of other active malignancies with in the past 3 years (P1a/1b) or past 5 years (P2a), except adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
  • Evidence of other clinically significant uncontrolled condition(s), including, but not limited to active systemic fungal infection; diagnosis of fever and neutropenia with in 1 week prior to study drug.
  • Received steroid therapy with in 7 days prior to 1st dose of study drug for anti-neoplastic intent.
  • Received any anti-cancer therapy, including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy, with in 14 days prior to first dose of study drug, or has not recovered to <Gr2 clinically significant AE(s) /toxicity(s) of the previous therapy.
  • Received a biologic with in 30 days prior to first dose.
  • Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications that are used to maintain the patency of a central venous catheter.
  • Received aspirin with in 7 days prior to first dose and during ABT-263 administration.
  • Consumed grapefruit or grapefruit products with in 3 days prior to first dose.
  • P1a/1b only: Diagnosed with Posttransplant lymphoproliferative disorder (PTLD); Burkitt's, Burkitt-like, or HIV-associate lymphoma; lymphoblastic lymphoma/leukemia; or multiple myeloma.
  • Subject has received CYP3A inhibitors (e.g., ketoconazole, clarithromycin) within 7 days prior to the administration of the first dose of ABT-263 (P2a).
  • Subject had a prior significant toxicity from another Bcl-2 family protein inhibitor (P2a).

Sites / Locations

  • Site Reference ID/Investigator# 4997
  • Site Reference ID/Investigator# 9104
  • Site Reference ID/Investigator# 2613
  • Site Reference ID/Investigator# 40243
  • Site Reference ID/Investigator# 4745
  • Site Reference ID/Investigator# 2628
  • Site Reference ID/Investigator# 23543
  • Site Reference ID/Investigator# 2627
  • Site Reference ID/Investigator# 2614
  • Site Reference ID/Investigator# 5383
  • Site Reference ID/Investigator# 12306
  • Site Reference ID/Investigator# 8941

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1a and 1b

Arm A (Phase 2a)

Arm B (Phase 2a)

Extension Study

Arm Description

Relapsed or refractory lymphoid malignancies

Relapsed or refractory follicular lymphoma

Relapsed or refractory mantle cell, peripheral T-cell, cutaneous T-cell lymphoma including mycosis fungoides and Sezary syndrome, or other indolent B-cell lymphomas such as marginal zone lymphoma

Relapsed or refractory follicular lymphoma or Relapsed or refractory mantle cell, peripheral T-cell, cutaneous T-cell lymphoma including mycosis fungoides and Sezary syndrome, or other indolent B-cell lymphomas such as marginal zone lymphoma

Outcomes

Primary Outcome Measures

Phase 1a: Determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) and schedule - intermittent dosing.
1a: Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 14/21 day dosing schedule
Phase 1b: Determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) and schedule - continuous dosing.
Phase 1b: Determination of ABT-263 dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 21 day continuous dosing schedule.
Phase 2a: Continued assessment of safety profile at the recommended Phase 2 dose (RPTD) and schedule - continuous dosing.
Phase 2a: Continued assessment of the safety profile of ABT-263 at the Recommended Phase 2 Dose (RPTD) and schedule under a 21 day continuous dosing.
Phase 2a: Assessment of preliminary efficacy signals including biomarker assessment - continuous dosing.
Phase 2a: Assessment of the preliminary efficacy signals of ABT-263, including biomarker assessment, at the Recommended Phase 2 Dose (RPTD) and schedule under a 21 day continuous dosing.
Extension Study: Continued assessment of the safety profile of ABT-263
Continued assessment of the safety profile of ABT-263.
Extension Study: Continued assessment of the preliminary efficacy signals of ABT-263.
Continued assessment of the preliminary efficacy signals of ABT-263.

Secondary Outcome Measures

Phase 1a or Phase 1b safety assessment
Assessment of the safety of ABT-263
Phase 1a, Phase 1b, or Phase 2a pharmacokinetic profile evaluation
Evaluation of pharmacokinetic profile of ABT-263.
Phase 1a effect of food on bioavailability
Evaluation of the effect of food on bioavailability

Full Information

First Posted
November 30, 2006
Last Updated
July 28, 2021
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00406809
Brief Title
A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Official Title
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose in subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263 using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy in subject with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects who remain active 1 year after the last subject enrolls or who have been on study approximately 1 year to continue receiving ABT-263 with less frequent study evaluations. Subjects in the Extension Study will continue receiving study drug for up to 7 years after the last subject transitions to the Extension Study, or until disease progression or toxicity that necessitates discontinuation (whichever comes first).
Detailed Description
Enrollment breakdown: Entered Study: Phase 1a: 39; Phase 1b: 19; Phase 2a: 33; Total: 91 Entered Treatment: Phase 1a: 38; Phase 1b: 17; Phase 2a: 26; Total: 81

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphoid Leukemia, Lymphoid Malignancies, Non-Hodgkin's Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Peripheral T-cell Lymphoma
Keywords
Sezary syndrome, cutaneous T-cell lymphoma, follicular lymphoma, marginal zone lymphoma, indolent T-cell lymphoma, Navitoclax, Non-Hodgkin's lymphoma, peripheral T-cell lymphoma, ABT-263, lymphoid malignancies, chronic lymphoid leukemia, mycosis fungoides, mantle cell lymphoma

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
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1a and 1b
Arm Type
Experimental
Arm Description
Relapsed or refractory lymphoid malignancies
Arm Title
Arm A (Phase 2a)
Arm Type
Experimental
Arm Description
Relapsed or refractory follicular lymphoma
Arm Title
Arm B (Phase 2a)
Arm Type
Experimental
Arm Description
Relapsed or refractory mantle cell, peripheral T-cell, cutaneous T-cell lymphoma including mycosis fungoides and Sezary syndrome, or other indolent B-cell lymphomas such as marginal zone lymphoma
Arm Title
Extension Study
Arm Type
Experimental
Arm Description
Relapsed or refractory follicular lymphoma or Relapsed or refractory mantle cell, peripheral T-cell, cutaneous T-cell lymphoma including mycosis fungoides and Sezary syndrome, or other indolent B-cell lymphomas such as marginal zone lymphoma
Intervention Type
Drug
Intervention Name(s)
ABT-263
Intervention Description
Oral solution Phase 1 dosing was under two different schedules: 14 days on drug, 7 days off or 21 days continuous dosing. Oral solution and tablets Phase 2a dosing under 21 day continuous dosing. - 150 mg lead-in dose for 7-14 days followed by a 325 mg continuous once daily dose.
Primary Outcome Measure Information:
Title
Phase 1a: Determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) and schedule - intermittent dosing.
Description
1a: Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 14/21 day dosing schedule
Time Frame
Repeating sequence of 14 days on therapy and 7 days off.
Title
Phase 1b: Determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) and schedule - continuous dosing.
Description
Phase 1b: Determination of ABT-263 dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 21 day continuous dosing schedule.
Time Frame
21 day continuous dosing.
Title
Phase 2a: Continued assessment of safety profile at the recommended Phase 2 dose (RPTD) and schedule - continuous dosing.
Description
Phase 2a: Continued assessment of the safety profile of ABT-263 at the Recommended Phase 2 Dose (RPTD) and schedule under a 21 day continuous dosing.
Time Frame
21 day continuous dosing.
Title
Phase 2a: Assessment of preliminary efficacy signals including biomarker assessment - continuous dosing.
Description
Phase 2a: Assessment of the preliminary efficacy signals of ABT-263, including biomarker assessment, at the Recommended Phase 2 Dose (RPTD) and schedule under a 21 day continuous dosing.
Time Frame
21 day continuous dosing.
Title
Extension Study: Continued assessment of the safety profile of ABT-263
Description
Continued assessment of the safety profile of ABT-263.
Time Frame
21 day continuous dosing
Title
Extension Study: Continued assessment of the preliminary efficacy signals of ABT-263.
Description
Continued assessment of the preliminary efficacy signals of ABT-263.
Time Frame
day continuous dosing
Secondary Outcome Measure Information:
Title
Phase 1a or Phase 1b safety assessment
Description
Assessment of the safety of ABT-263
Time Frame
Repeating sequence of 14 days on therapy and 7 days off OR 21 day continuous dosing.
Title
Phase 1a, Phase 1b, or Phase 2a pharmacokinetic profile evaluation
Description
Evaluation of pharmacokinetic profile of ABT-263.
Time Frame
Repeating sequence of 14 days on therapy and 7 days off OR 21 day continuous dosing.
Title
Phase 1a effect of food on bioavailability
Description
Evaluation of the effect of food on bioavailability
Time Frame
Repeating sequence of 14 days on therapy and 7 days off.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnoses: 1a/1b - lymphoid malignancy; 2a, Arm A - follicular lymphoma; 2a, Arm B - mantle cell, peripheral or cutaneous T-cell lymphomas including mycosis fungoides and Sezary syndrome or other indolent B-cell lymphomas such as marginal zone lymphoma; Received at least 1 prior chemotherapy treatment regimen (P1a/1b) and relapsed or refractory disease (P2a). Eastern Cooperative Oncology Group (ECOG) score of <= 1. Magnetic Resonance Imaging (MRI)/computed tomography (CT) negative for subdural or epidural hematoma w/in 28 days prior to first dose, if clinically indicated. Stable dose of Selective serotonin reuptake inhibitors (SSRI) antidepressants for at least 21 days prior to 1st dose. Adequate bone marrow (BM) independent of any growth factor support (except with heavily infiltrated bone marrow (80% or more)): Absolute Neutrophil Count (ANC) >= 1000/µL; Platelets >= 100,000/mm3 (entry count must be independent of transfusion with in 14 days of Screening); Hemoglobin >= 9.0/dL. Adequate coagulation, renal, and hepatic function: Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 x Upper Limit of Normal (ULN); Bilirubin <= 1.5 x ULN; Gilbert's Syndrome may have a bilirubin > 1.5 x ULN; Coagulation: Activated partial thromboplastin time (aPTT), Prothrombin Time (PT), not to exceed 1.2 x ULN Females must be surgically sterile, postmenopausal (at least 1 year), or negative results for a pregnancy test performed at Screening on a serum sample obtained with in 14 days prior to initial dose, and prior to dosing on a urine sample obtained on C1 D-3 (P1a) or Lead-in D1 (P1b, P2a) if > 7 days since serum results. Females not surgically sterile or postmenopausal (at least 1 year) and non-vasectomized males must practice birth control. P2a only: History of autologous stem cell transplant must be > 6 months post transplant with adequate BM independent of growth factor support per lab reference range at Screening as follows: Absolute Neutrophil Count (ANC) >= 1,500/µL; Platelets >= 125,000/mm3 (entry platelet count must be independent of transfusion with in 14 days of Screening); Hemoglobin >= 10.0g/dL; Measurable disease by International Working Group (IWG)/National Cancer Institute- sponsored Working Group (NCI-WG) criteria. At least one of following for Pharmacodynamics (P2a): archived diagnostic Formalin Fixed Paraffin Embedded (FFPE) tumor tissue with no intervening treatment since biopsy, core needle biopsy of malignant lymph node, or bone marrow aspirate or core positive for lymphoma. Extension Study Inclusion Criteria Phase 2a subjects who enter the Extension Study must continue to meet all Inclusion and Exclusion criteria, with the exception of Inclusion Criterion regarding measurable disease by International Working Group (IWG)/National Cancer Institute- sponsored Working Group (NCI-WG) criteria and Inclusion Criteria regarding laboratory parameters for hematology, coagulation, and chemistry. Subjects entering the Extension Study must also have stable lab values per applicable laboratory reference ranges. In addition, subjects must also meet the following criteria: Subjects must meet the following hematology and coagulation lab criteria: Platelet counts must be >= 25,000/mm3 (untransfused). Platelet counts <= 50,000/mm3 must be stable and monitored at an increased frequency at the discretion of the investigator. Absolute Neutrophil count (ANC) >= 500/µL. ANC >= 500/µL and < 1,000/µL should be monitored at an increased frequency at the discretion of the investigator. Hemoglobin of >= 8.0 g/dL. aPTT, PT is not to exceed 1.2 x ULN. Chemistry values must not exceed Grade 2. Grade 2 chemistry labs should be monitored at an increased frequency at the discretion of the investigator. Subjects must meet the following chemistry criteria: Serum creatinine <= 3.0 x the upper normal limit (ULN) of institution's normal range. * AST and ALT <= 5.0 x the upper normal limit (ULN) of institution's normal range. Bilirubin <= 3.0 x ULN. Subjects with Gilbert's Syndrome may be allowed to have a Bilirubin > 3.0 x ULN based on a joint decision between the investigator and Abbott medical monitor. Exclusion Criteria: History of, or is, clinically suspicious for cancer-related Central Nervous System (CNS) disease, lymphoid or non-lymphoid. Undergone an allogeneic or autologous stem cell transplant. Underlying, predisposing condition of bleeding or currently exhibits signs of clinically significant bleeding. Recent history of non-chemotherapy induced thrombocytopenic associated bleeding with in 1 year prior to first dose. Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis. Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions with in 1 year prior to first dose. Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. Females pregnant or breast-feeding. Positive for human immunodeficiency virus (HIV) History of other active malignancies with in the past 3 years (P1a/1b) or past 5 years (P2a), except adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent. Evidence of other clinically significant uncontrolled condition(s), including, but not limited to active systemic fungal infection; diagnosis of fever and neutropenia with in 1 week prior to study drug. Received steroid therapy with in 7 days prior to 1st dose of study drug for anti-neoplastic intent. Received any anti-cancer therapy, including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy, with in 14 days prior to first dose of study drug, or has not recovered to <Gr2 clinically significant AE(s) /toxicity(s) of the previous therapy. Received a biologic with in 30 days prior to first dose. Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications that are used to maintain the patency of a central venous catheter. Received aspirin with in 7 days prior to first dose and during ABT-263 administration. Consumed grapefruit or grapefruit products with in 3 days prior to first dose. P1a/1b only: Diagnosed with Posttransplant lymphoproliferative disorder (PTLD); Burkitt's, Burkitt-like, or HIV-associate lymphoma; lymphoblastic lymphoma/leukemia; or multiple myeloma. Subject has received CYP3A inhibitors (e.g., ketoconazole, clarithromycin) within 7 days prior to the administration of the first dose of ABT-263 (P2a). Subject had a prior significant toxicity from another Bcl-2 family protein inhibitor (P2a).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mack Mabry, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 4997
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Site Reference ID/Investigator# 9104
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Site Reference ID/Investigator# 2613
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Site Reference ID/Investigator# 40243
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Site Reference ID/Investigator# 4745
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Site Reference ID/Investigator# 2628
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Site Reference ID/Investigator# 23543
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site Reference ID/Investigator# 2627
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site Reference ID/Investigator# 2614
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site Reference ID/Investigator# 5383
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Site Reference ID/Investigator# 12306
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Site Reference ID/Investigator# 8941
City
Edmonton
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21094089
Citation
Wilson WH, O'Connor OA, Czuczman MS, LaCasce AS, Gerecitano JF, Leonard JP, Tulpule A, Dunleavy K, Xiong H, Chiu YL, Cui Y, Busman T, Elmore SW, Rosenberg SH, Krivoshik AP, Enschede SH, Humerickhouse RA. Navitoclax, a targeted high-affinity inhibitor of BCL-2, in lymphoid malignancies: a phase 1 dose-escalation study of safety, pharmacokinetics, pharmacodynamics, and antitumour activity. Lancet Oncol. 2010 Dec;11(12):1149-59. doi: 10.1016/S1470-2045(10)70261-8. Epub 2010 Nov 18.
Results Reference
background
PubMed Identifier
33236943
Citation
de Vos S, Leonard JP, Friedberg JW, Zain J, Dunleavy K, Humerickhouse R, Hayslip J, Pesko J, Wilson WH. Safety and efficacy of navitoclax, a BCL-2 and BCL-XL inhibitor, in patients with relapsed or refractory lymphoid malignancies: results from a phase 2a study. Leuk Lymphoma. 2021 Apr;62(4):810-818. doi: 10.1080/10428194.2020.1845332. Epub 2020 Nov 25.
Results Reference
derived

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A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

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