Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
NCT07387471 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2026-05-19
Summary
Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)/LPL receiving venetoclax.
Venetoclax is being investigated in the treatment of WM/LPL. Participants will receive oral venetoclax at doses ramping up to the target dose, as part of treatment. Approximately 14 adult participants with WM/LPL will be enrolled in the study at approximately 20 sites in Japan.
Participants will receive oral venetoclax at doses ramping up to the target dose. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Conditions
Interventions
- DRUG
-
Oral
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-17
- Primary Completion
- 2028-07-31
- Completion
- 2028-07-31
- FDA Drug
- Yes
Countries
- Japan
Study Locations
More Related Trials
-
A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
NCT03797261 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT02966756 ·Status: RECRUITING ·Phase: PHASE2
-
Venetoclax in Addition to Blinatumomab in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)
NCT05182385 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT05105841 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
NCT05952037 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia
NCT05807347 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT06177067 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia
NCT04813263 ·Status: COMPLETED
-
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
NCT03629171 ·Status: RECRUITING ·Phase: PHASE2
-
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
NCT01471782 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT06007911 ·Status: WITHDRAWN ·Phase: PHASE1
-
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT05211570 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Clinical Study of Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia
NCT05918198 ·Status: RECRUITING ·Phase: PHASE2
-
Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
NCT04872790 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
NCT04797767 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT01349049 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
NCT07039877 ·Status: RECRUITING ·Phase: PHASE2
-
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
NCT06045819 ·Status: RECRUITING
-
Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)
NCT04758975 ·Status: RECRUITING ·Phase: PHASE2
-
Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia
NCT03455517 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan
NCT06362044 ·Status: COMPLETED
-
Venetoclax to Augment Epigenetic Modification and Chemotherapy
NCT05317403 ·Status: RECRUITING ·Phase: PHASE1
-
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
NCT03319901 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Venetoclax After TKI to Target Persisting Stem Cells in CML
NCT05701215 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
NCT01466179 ·Status: COMPLETED ·Phase: PHASE2