A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies

Phase 1 Study of Lonitoclax (ZE50-0134) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas

This Phase 1, open-label, multicenter study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of lonitoclax (ZE50-0134) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and select low-grade B-cell lymphomas.

The study has two sequential parts. Part 1 uses dose escalation to determine the biologically effective dose and/or maximum tolerated dose of lonitoclax. Participants receive a 3-day step-up regimen followed by continuous once-daily or twice-daily oral dosing in 28-day cycles. Part 2 is a randomized dose-expansion comparison of two selected lonitoclax dose levels in venetoclax-naive participants with relapsed or refractory CLL/SLL. Treatment may continue for up to 12 cycles and, for participants deriving clinical benefit, for up to 24 cycles with approval from the Medical Monitor.

Study Overview

• Status: Recruiting
• Conditions: CLL (Chronic Lymphocytic Leukemia); SLL (Small Lymphocytic Lymphoma); Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia; Marginal Zone Lymphoma(MZL); CLL / SLL
• Intervention / Treatment: Drug: Lonitoclax (ZE50-0134)

Detailed Description

This is an open-label, multicenter Phase 1 study with two sequential parts.

Part 1 is a non-randomized dose-escalation study in participants with relapsed or refractory CLL/SLL or select low-grade lymphomas. A standard 3+3 design is used to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of lonitoclax (ZE50-0134), and to identify a biologically effective dose and/or maximum tolerated dose. Planned dose levels include once-daily and twice-daily regimens. Dose Levels 6a and 6b may enroll concurrently. Dose-limiting toxicities are evaluated during Cycle 1.

To reduce the risk of tumor lysis syndrome, participants receive intravenous hydration beginning on Day -1 and a 3-day step-up dosing regimen as inpatients. After step-up dosing, the assigned lonitoclax dose is administered orally once daily or twice daily in a fed state. Each treatment cycle is 28 days.

Part 2 is a randomized dose-expansion portion in venetoclax-naive participants with relapsed or refractory CLL/SLL. Approximately 15 participants are assigned to each of two selected dose levels: the biologically effective dose or maximum tolerated dose and one lower dose level, provided activity is observed. Part 2 evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity to support selection of a recommended Phase 2 dose.

Treatment is continuous for up to 12 cycles. Participants deriving clinical benefit may continue treatment for up to 24 cycles at the investigator's discretion with Medical Monitor approval. Participants are followed for safety after treatment and for disease progression, subsequent treatment, and survival.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ekaterina Dokukina, PhD MD; Phone Number: +1 858 353 4108; Email: kdokukina@eileanther.com

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute, St. Matthews Campus
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • Recruiting
      • University of Cincinnati
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
  • Texas
    • Dallas, Texas, United States, 75390
      • Not yet recruiting
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women aged 18 years or older.

2. Disease as defined below:

   • Part 1: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 2 prior therapies that included a covalent Bruton tyrosine kinase inhibitor (BTKi) and venetoclax, or after the participant declined venetoclax; or progressive low-grade lymphoma, including marginal zone lymphoma or lymphoplasmacytic lymphoma (including Waldenstrom macroglobulinemia), after at least 1 prior therapy that included either a BTKi or CD20 antibody-based therapy.
   • Part 2: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 1 prior therapy that included a BTKi; participants must be venetoclax naive.
3. Disease requiring therapy in the investigator's opinion.

4. Adequate bone marrow, liver, and renal function during screening:

   • Absolute neutrophil count greater than 0.75 x 10^9/L; for participants with documented bone marrow involvement, at least 0.5 x 10^9/L.
   • Platelet count greater than 50 x 10^9/L; for participants with documented bone marrow involvement, at least 30 x 10^9/L.
   • AST and ALT no greater than 3.0 times the upper limit of normal.
   • Total bilirubin no greater than 1.5 times the upper limit of normal. Participants with suspected or known Gilbert disease may have total bilirubin up to 3 times the upper limit of normal if predominantly unconjugated.
   • Creatinine- or cystatin C-based glomerular filtration rate at least 60 mL/min, or at least 40 mL/min with a normal urine neutrophil gelatinase-associated lipocalin level. Estimated GFR is calculated using the Modification of Diet in Renal Disease formula.
5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
6. For women of childbearing potential, a negative serum or urine pregnancy test within 7 days before the first dose and a negative result before each treatment cycle. Pregnancy testing is not required for women older than 50 years with at least 12 months of amenorrhea; women aged 50 years or younger with at least 6 months of spontaneous amenorrhea and follicle-stimulating hormone greater than 40 mIU/mL; or permanently sterilized women, including hysterectomy, bilateral salpingectomy, or uterine ablation.
7. Women and men of reproductive potential must agree to use highly effective contraception from signing informed consent until 90 days after the last dose of study drug.
8. Ability to understand and willingness to sign written informed consent, including consent for genetic biomarker analyses from tissue and plasma, before study-specific procedures.

Exclusion Criteria:

1. Part 2 only: Prior venetoclax treatment.
2. Known active Richter transformation. Participants previously treated for Richter transformation may be eligible if they have been in remission for more than 2 years, have no evidence of Richter transformation, and have CLL only.
3. Known hypersensitivity to lonitoclax, its excipients, or an agent administered in association with the study.
4. Clinically significant cardiac disease, including congestive heart failure greater than New York Heart Association Class II; uncontrolled coronary artery disease; unstable angina; new-onset angina or myocardial infarction within 6 months before first dose; major regional wall-motion abnormalities on baseline echocardiography; or cardiac arrhythmias requiring antiarrhythmic treatment other than beta-blockers or digoxin.
5. Known active cytomegalovirus, hepatitis B virus, or hepatitis C virus infection.
6. HIV-positive disease that is not adequately controlled by antiviral therapy. Participants with adequately controlled HIV may enroll.
7. Known active SARS-CoV-2 infection. Prior infection is allowed if the participant completely recovered more than 14 days previously.
8. Active clinically serious infection of Grade greater than 2 requiring parenteral therapy. Participants may be eligible after the infection resolves.
9. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days before enrollment.
10. Allogeneic bone marrow transplant within 4 months before first dose. Immunosuppressive therapy related to the transplant must be completed before enrollment.
11. Active cancer that limits expected survival to less than 2 years or requires anticancer therapy concomitantly with study treatment. Exceptions may include resected localized skin, breast, or prostate cancer and malignancies treated with hormonal or immune therapies alone; secondary cancers should be discussed with the Medical Monitor.
12. Physical examination or laboratory finding that contraindicates investigational therapy or otherwise places the participant at excessively high treatment risk in the investigator's opinion.
13. Requirement for ongoing immunosuppressive therapy, including systemic corticosteroids, for cancer or another condition. Topical or inhaled corticosteroids and low-dose systemic steroids of no more than 20 mg prednisone equivalent per day are permitted for comorbid conditions. Short courses above this dose before first dose and during Week 1 may be used for tumor flare.
14. Major surgery or significant trauma within 4 weeks before first dose.
15. Breastfeeding. Breastfeeding must be discontinued before and during treatment and for at least 3 months after treatment ends.
16. QT interval corrected using Fridericia's formula greater than 470 milliseconds that cannot be corrected with electrolyte replacement, hydration, or medication modification. This criterion does not apply to participants with a pacemaker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Level -1 - 75 mg QD; Optional de-escalation cohort. Participants receive lonitoclax 25 mg once daily on Day 1, 50 mg once daily on Day 2, and 75 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 1 - 100 mg QD; Participants receive lonitoclax 25 mg once daily on Day 1, 50 mg once daily on Day 2, and 100 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 2 - 200 mg QD; Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 200 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 3 - 400 mg QD; Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 400 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 4 - 600 mg QD; Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 600 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 5 - 800 mg QD; Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 800 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 6a - 1000 mg QD; Participants receive lonitoclax 100 mg once daily on Day 1, 250 mg once daily on Day 2, and 1000 mg once daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles. Dose Levels 6a and 6b may enroll concurrently.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 6b - 500 mg BID; Participants receive lonitoclax 50 mg twice daily on Day 1, 100 mg twice daily on Day 2, and 500 mg twice daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles. Dose Levels 6a and 6b may enroll concurrently.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 7b - 750 mg BID; Participants receive lonitoclax 100 mg twice daily on Day 1, 250 mg twice daily on Day 2, and 750 mg twice daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 1: Dose Level 8b - 1000 mg BID; Participants receive lonitoclax 100 mg twice daily on Day 1, 250 mg twice daily on Day 2, and 1000 mg twice daily on Day 3 and thereafter. Treatment is administered orally in a fed state in 28-day cycles.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 2: Selected Dose A - BED/MTD; Participants with relapsed or refractory CLL/SLL who are venetoclax naive are randomized to a selected lonitoclax dose corresponding to the biologically effective dose or maximum tolerated dose identified in Part 1. The selected regimen may be once daily or twice daily. Approximately 15 participants are planned.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
Experimental: Part 2: Selected Dose B - One Dose Level Lower; Participants with relapsed or refractory CLL/SLL who are venetoclax naive are randomized to one lonitoclax dose level below the biologically effective dose or maximum tolerated dose selected in Part 1, provided activity is observed. The selected regimen may be once daily or twice daily. Approximately 15 participants are planned.	Drug: Lonitoclax (ZE50-0134); Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of treatment-emergent adverse events and serious adverse events	Number and percentage of participants with treatment-emergent adverse events, serious adverse events, clinically significant laboratory abnormalities, adverse events related to lonitoclax, and adverse events leading to treatment discontinuation. Adverse events are graded using NCI CTCAE Version 5.0.	From first dose through 30 days after the last dose; treatment may continue for up to 24 cycles (28 days per cycle).
Incidence of dose-limiting toxicities in Part 1	Number and percentage of Part 1 participants experiencing a protocol-defined dose-limiting toxicity during the dose-limiting toxicity assessment period.	Cycle 1 (Days 1-28).
Determination of the biologically effective dose and/or maximum tolerated dose	The selected dose is determined from the totality of safety, dose-limiting toxicity, pharmacokinetic, pharmacodynamic, and early response data across Part 1 dose cohorts according to the protocol-defined dose-escalation rules.	After completion of Cycle 1 for evaluable participants in each Part 1 dose cohort.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Proportion of participants whose best overall response is partial response or better, as assessed by the investigator using iwCLL criteria for CLL, Lugano criteria for SLL and other applicable low-grade lymphomas, or Waldenstrom response criteria, as applicable.	From first dose through end of treatment, up to 24 cycles (28 days per cycle).
Duration of response (DOR)	For participants with partial response or better, time from the first documented response until disease progression or death from any cause.	From first documented response until progression, death, withdrawal, loss to follow-up, or sponsor termination; assessed during treatment and long-term follow-up.
Progression-free survival (PFS)	Time from first dose until disease progression by the applicable disease-specific response criteria or death from any cause.	From first dose until progression, death, withdrawal, loss to follow-up, or sponsor termination; assessed during treatment and long-term follow-up.
Time to next treatment (TTNT)	Time from first dose of lonitoclax to initiation of a non-protocol anticancer treatment for CLL/SLL or death.	From first dose until initiation of new anticancer treatment, death, withdrawal, loss to follow-up, or sponsor termination.
Maximum observed plasma concentration (Cmax) of lonitoclax	Maximum observed plasma concentration derived from serial plasma concentration measurements after lonitoclax administration.	Cycle 1 Days 1-4, 8, 15, and 22; Cycle 2 Days 1-2; and end-of-treatment/early-termination sampling as applicable.
Area under the plasma concentration-time curve (AUC) of lonitoclax	AUC derived from serial plasma concentration measurements. For QD dosing, planned calculations include AUC0-8h or AUC0-6h and AUC0-24h. For BID dosing, planned calculations include AUC0-8h or AUC0-6h after the morning dose.	Cycle 1 Days 1-3 and Cycle 2 Day 1, based on protocol-specified serial PK sampling.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of undetectable measurable residual disease in blood and bone marrow	Proportion of evaluable participants with undetectable measurable residual disease by flow cytometry and/or next-generation sequencing, including bone marrow assessment after 12 cycles.	Peripheral blood at the ends of Cycles 3, 6, 9, and 12; bone marrow at the end of Cycle 12.
Change from baseline in caspase 3 activation	Change in caspase 3 activation in CLL or lymphoma cells and exploratory relationship with lonitoclax pharmacokinetics and clinical response.	Screening/baseline through Cycle 1 Day 4.
Change from baseline in immune-cell populations	Change in absolute numbers of CD8 T cells, natural killer cells, and normal B cells during lonitoclax treatment.	Baseline; Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1; Cycle 7 Day 1; and safety follow-up/end of treatment/early termination, as applicable.
Molecular and protein markers associated with resistance or response	Exploratory evaluation of serial samples for BCL2, BAX, and other escape mutations; expression of alternative BCL2-family proteins; alternative biomarkers; and clonal evolution in relation to response, progression, and resistance.	Baseline and serially during treatment, with additional sampling at relapse/progression and end of treatment, as available.
Overall survival	Time from first dose until death from any cause.	From first dose until death, withdrawal of consent, loss to follow-up, or sponsor termination; survival follow-up approximately every 3 months.

Collaborators and Investigators

• Sponsor: Lomond Therapeutics Holdings, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: venetoclax; relapsed or refractory; dose escalation; BTK inhibitor; dose expansion; dose optimization; tumor lysis syndrome; BCL2 inhibitor; Lonitoclax; ZE50-0134
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Leukemia, Lymphocytic, Chronic, B-Cell; Waldenstrom Macroglobulinemia; Lymphoma, B-Cell, Marginal Zone; Leukemia, B-Cell; Tumor Lysis Syndrome
• Other Study ID Numbers: ZE50-0134-0002

Drug and device information, study documents

• 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