A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

• ClinicalTrials.gov Identifier: NCT01889186
• Recruitment Status: Completed
• First Posted: June 28, 2013
• Results First Posted: December 16, 2021
• Last Update Posted: December 16, 2021
• Sponsor: AbbVie
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): AbbVie

Study Description

Brief Summary:

This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion.

Condition or disease	Intervention/treatment	Phase
Chronic Lymphocytic Leukemia; 17p Deletion; Cancer of the Blood and Bone Marrow	Drug: ABT-199 (Main Cohort); Drug: ABT-199 (Safety Expansion Cohort)	Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

This study was designed to enroll approximately 150 participants in 2 cohorts: a main cohort of approximately 100 participants, and a safety expansion (SE) cohort of approximately 50 participants. The primary objective of the main cohort was to evaluate the efficacy of ABT-199 monotherapy in participants with R/R CLL harboring the 17p deletion. The primary objective of the safety expansion cohort was to evaluate the safety of ABT-199 in approximately 50 participants with R/R CLL harboring 17p deletion treated per updated tumor lysis syndrome (TLS) prophylaxis and management measures.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion
• Actual Study Start Date: June 27, 2013
• Actual Primary Completion Date: October 28, 2020
• Actual Study Completion Date: December 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Main Cohort; Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.	Drug: ABT-199 (Main Cohort); Participants received a test dose of ABT-199 of ≤ 20 mg on Week 1 Day 1 of the Lead-In Period. For those with significant electrolyte and/or lymphocyte changes within 24 hours of the first dose, the 20 mg dose was maintained for 7 days with escalation to 50 mg on Week 2 Day 1. If none of the electrolyte and/or lymphocyte changes occurred within 24 hours from ABT-199 20 mg dose administration, the participant was dose-escalated to 50 mg on Week 1 Day 2. After the first dose of 50 mg, if no laboratory abnormalities occurred, the participant remained on the 50 mg dose through Week 1. After receiving the 50 mg dose for approximately 1 week (6 to 7 days), the following dose escalation proceeded with weekly increases in dose: → 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose), as tolerated.; Other Names: Venetoclax; GDC-0199
Experimental: Safety Expansion Cohort; Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.	Drug: ABT-199 (Safety Expansion Cohort); Participants received an initial dose of ABT-199 of 20 mg on Week 1 Day 1 of the Lead-In Period. If one or more electrolyte changes (from the 0 hr measurement prior to dosing) suggestive of laboratory tumor lysis syndrome (LTLS) or clinical TLS (CTLS) occurred within 24 hours of the 20 mg dose, no additional doses were administered until resolution. Upon resolution of laboratory abnormalities, the 20 mg dose was continued through Week 1. If no significant findings suggestive of clinical or laboratory TLS occurred within 24 hours, the 20 mg dose was continued through Week 1 Day 7, and escalated to a dose of 50 mg on Week 2 Day 1. Those who had drug interruptions may have been allowed to escalate to and be maintained at 50 mg for 1 week after they had been on a 20 mg dose for at least 1 week (5 - 7 days). After a week at 50 mg, weekly dose escalations were implemented as follows: 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose) as tolerated.; Other Names: Venetoclax; GDC-0199

Outcome Measures

Primary Outcome Measures :

1. Overall Response Rate (Main Cohort) [ Time Frame: Up to 36 weeks ]
   The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort.
2. Number of Participants With Adverse Events (Safety Expansion Cohort) [ Time Frame: From the first dose of study drug until 30 days following last dose of study drug (up to 69 months) ]
   An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Secondary Outcome Measures :

1. Overall Response Rate (ORR) (Safety Expansion Cohort) [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria.
2. Complete Remission (CR) Rate [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate.
3. Partial Remission (PR) Rate [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   PR rate was defined as the proportion of participants who achieved a nodular partial remission (nPR) or PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a nPR or PR were considered to be non-responders in the calculation of PR rate.
4. Duration of Overall Response [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis.
5. Progression-free Survival [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
6. Event-free Survival [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Event-free survival (EFS) was defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy. If the specified event (disease progression, death, start of a new anti-leukemic treatment) did not occur, participants were censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
7. Time to Progression [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Time to progression (TTP) was defined as the number of days from the date of first dose to the date of earliest disease progression. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant did not experience disease progression, then the data was censored at the date of last available disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
8. Time to First Response [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis.
9. Time to 50% Reduction in Absolute Lymphocyte Count [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
   Time to 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC > 5 × 10^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, the participant's data were not included in the analysis.
10. Overall Survival [ Time Frame: Up to the data cutoff date of 15 December 2020, approximately 7.5 years of follow-up ]
    Overall survival (OS) was defined as number of days from the date of first dose to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later.
11. Percentage of Participants Who Moved on to Stem Cell Transplant [ Time Frame: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up ]
    The percentage of participants who moved on to stem cell transplant was summarized.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participant must be greater than or equal to 18 years of age.

• Participant must have diagnosis of chronic lymphocytic leukemia (CLL) that meets published 2008 Modified IWCLL NCI-WG (International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group) Guidelines.

  • Participant has an indication for treatment according to the 2008 Modified IWCLL NCI WG Guidelines;
  • Participant has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam);
  • Participant must be refractory or have relapsed after receiving at least one prior line of therapy (participants that have progressed after 1 cycle of treatment or have completed at least 2 cycles of treatment for a given line of therapy) or previously untreated CLL (previously untreated CLL participants must have received no prior chemotherapy or immunotherapy. Participants with a history of emergency, loco-regional radiotherapy (e.g., for relief of compressive signs or symptoms) are eligible. In addition, participants must meet the CLL diagnostic criteria above and must have > 5 × 10^9/L B-Lymphocytes in the peripheral blood.);
  • Participants must have 17p deletion, assessed by local laboratory (in bone marrow or peripheral blood) or assessed by central laboratory (peripheral blood).
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.

• Participant must have adequate bone marrow function at Screening as follows:

  • Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL, or
  • For subjects with an ANC less than 1000/µL at Screening and bone marrow heavily infiltrated with underlying disease (unless cytopenia is clearly due to marrow involvement of CLL), growth factor support may be administered after Screening and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria (greater than or equal to 1000/µL);
  • Platelets greater than 30,000/mm^3 (without transfusion support within 14 days of Screening, without evidence of mucosal bleeding, without known history of bleeding episode within 3 months of Screening, and without history of bleeding disorder);
  • Hemoglobin greater than or equal to 8.0 g/dL.

• Participant must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:

  • Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × the upper limit of normal;
  • Calculated creatinine clearance greater than 50 mL/min using 24-hour Creatinine Clearance or modified Cockcroft-Gault equation (using Ideal Body Mass [IBM] instead of Mass). For participants that have body mass index (BMI) of > 30 kg/m^2 or < 19 kg/m^2, 24-hour measured urine creatinine clearance is required;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 × the upper normal limit of institution's normal range; Bilirubin less than or equal to 1.5 × upper limit of normal. Participants with Gilbert's Syndrome may have a bilirubin greater 1.5 × upper limit of normal, per correspondence between the investigator and AbbVie medical monitor.
• For participants at high risk of tumor lysis syndrome a pre-approval by the AbbVie medical monitor is required prior to enrollment.

Exclusion Criteria:

• Participant has undergone an allogeneic stem cell transplant.
• Participant has developed Richter's transformation confirmed by biopsy.
• Participant has prolymphocytic leukemia.
• Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids.
• Participant has previously received ABT-199.
• Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.

• Participant has received any of the following within 14 days or 5 half-lives as applicable prior to the first dose of study drug, or has not recovered to less than Common Toxicity Criteria (CTC) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:

  • Any anti-cancer therapy including chemotherapy, or radiotherapy;
  • Investigational therapy, including targeted small molecule agents.
• Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

Contacts and Locations

Locations

United States, Arizona

University of Arizona Cancer Center - North Campus /ID# 96748

Tucson, Arizona, United States, 85719-1478

United States, California

City of Hope /ID# 112875

Duarte, California, United States, 91010

Moore UC San Diego Cancer Center /ID# 91793

La Jolla, California, United States, 92093

Stanford University School of Med /ID# 105117

Stanford, California, United States, 94305-2200

United States, District of Columbia

Georgetown University Hospital /ID# 96954

Washington, District of Columbia, United States, 20007

United States, Illinois

Northwestern University Feinberg School of Medicine /ID# 92499

Chicago, Illinois, United States, 60611-2927

The University of Chicago Medical Center /ID# 96960

Chicago, Illinois, United States, 60637-1443

Ingalls Memorial Hosp /ID# 92497

Harvey, Illinois, United States, 60426

United States, Massachusetts

Dana-Farber Cancer Institute /ID# 92494

Boston, Massachusetts, United States, 02215

United States, Michigan

Henry Ford Health System /ID# 97795

Detroit, Michigan, United States, 48202

United States, New Jersey

Hackensack Univ Med Ctr /ID# 92500

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey /ID# 92513

New Brunswick, New Jersey, United States, 08903

United States, New York

Columbia Univ Medical Center /ID# 103835

New York, New York, United States, 10032-3725

Columbia Univ Medical Center /ID# 94716

New York, New York, United States, 10032-3725

United States, Ohio

Cleveland Clinic Main Campus /ID# 92495

Cleveland, Ohio, United States, 44195

United States, Texas

University of Texas MD Anderson Cancer Center /ID# 92521

Houston, Texas, United States, 77030

Australia, New South Wales

Royal North Shore Hospital /ID# 98836

St Leonards, New South Wales, Australia, 2065

Australia, Victoria

John Fawkner Private Hospital /ID# 98835

Coburg, Victoria, Australia, 3058

Peter MacCallum Cancer Ctr /ID# 91795

Melbourne, Victoria, Australia, 3000

Royal Melbourne Hospital /ID# 91794

Parkville, Victoria, Australia, 3050

Canada, Quebec

Duplicate_Jewish General Hospital /ID# 99476

Montreal, Quebec, Canada, H3T 1E2

France

Centre Hospitalier Lyon Sud /ID# 98839

Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495

Hopital Avicenne - APHP /ID# 98840

Bobigny, Ile-de-France, France, 93000

Hopital Pitie Salpetriere /ID# 98842

Paris, France, 75651

Centre Henri Becquerel /ID# 98838

Rouen, France, 76038

Germany

Universitaetsklinik Heidelberg /ID# 98845

Heidelberg, Baden-Wuerttemberg, Germany, 69120

Uniklinik Koeln /ID# 98847

Köln, Nordrhein-Westfalen, Germany, 50937

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 113235

Kiel, Schleswig-Holstein, Germany, 24105

Universitaetsklinikum Ulm /ID# 92533

Ulm, Thueringen, Germany, 89081

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 113256

Dresden, Germany, 01307

Universitaetsklinikum Freiburg /ID# 113276

Freiburg, Germany, 79106

Universitaetsmedizin Goettingen /ID# 113258

Göttingen, Germany, 37075

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 113236

Mainz, Germany, 55131

Muenchen Klinik Schwabing /ID# 113275

Muenchen, Germany, 80804

Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 98848

Lublin, Lubelskie, Poland, 20-081

SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 98849

Krakow, Malopolskie, Poland, 31-501

Szpital Wojewodzki w Opolu /ID# 102855

Opole, Opolskie, Poland, 46-020

United Kingdom

Leicester Royal Infirmary /ID# 98865

Leicester, England, United Kingdom, LE1 5WW

The Royal Bournemouth Hospital /ID# 118975

Bournemouth, United Kingdom, BH7 7DW

Addenbrookes Hospital /ID# 119977

Cambridge, United Kingdom, CB2 0SP

St. James University Hospital /ID# 98863

Leeds, United Kingdom, LS9 7TF

Royal Liverpool and Broadgreen /ID# 98860

Liverpool, United Kingdom, L7 8XP

St Bartholomew's Hospital, Bar /ID# 98862

London, United Kingdom, EC1A 7BE

King's College Hospital NHS Foundation Trust /ID# 119975

London, United Kingdom, SE5 9RS

The Christie Hospital /ID# 98864

Manchester, United Kingdom, M20 4BX

Oxford Univ Hosp NHS Trust /ID# 119976

Oxford, United Kingdom, OX3 7LE

Derriford Hospital /ID# 118335

Plymouth, United Kingdom, PL6 8DH

Royal Marsden Hospital /ID# 98861

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

AbbVie

Genentech, Inc.

Investigators

• Study Director: ABBVIE INC.; AbbVie

  Study Documents (Full-Text)

Documents provided by AbbVie:

Study Protocol  [PDF] February 28, 2017

Statistical Analysis Plan  [PDF] April 27, 2018

More Information

Publications:

Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, Puvvada SD, Wendtner CM, Roberts AW, Jurczak W, Mulligan SP, Bottcher S, Mobasher M, Zhu M, Desai M, Chyla B, Verdugo M, Enschede SH, Cerri E, Humerickhouse R, Gordon G, Hallek M, Wierda WG. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016 Jun;17(6):768-778. doi: 10.1016/S1470-2045(16)30019-5. Epub 2016 May 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.

Stilgenbauer S, Eichhorst B, Schetelig J, Hillmen P, Seymour JF, Coutre S, Jurczak W, Mulligan SP, Schuh A, Assouline S, Wendtner CM, Roberts AW, Davids MS, Bloehdorn J, Munir T, Bottcher S, Zhou L, Salem AH, Desai M, Chyla B, Arzt J, Kim SY, Verdugo M, Gordon G, Hallek M, Wierda WG. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. J Clin Oncol. 2018 Jul 1;36(19):1973-1980. doi: 10.1200/JCO.2017.76.6840. Epub 2018 May 1. Erratum In: J Clin Oncol. 2019 Sep 1;37(25):2299.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01889186
• Other Study ID Numbers: M13-982; 2012-004027-20 ( EudraCT Number )
• First Posted: June 28, 2013
• Results First Posted: December 16, 2021
• Last Update Posted: December 16, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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 and 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

• 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

Keywords provided by AbbVie:

Chronic Lymphocytic Leukemia; 17p Deletion

Additional relevant MeSH terms:

Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Venetoclax; Antineoplastic Agents