A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Study details:
This study will test the safety of novel sonrotoclax dosing with gradual increases of sonrotoclax dose over specified periods until the intended target daily dose is reached. The focus will be on tumor lysis syndrome (TLS) and related toxicity signals. Sonrotoclax is a drug that works by blocking a protein called B-cell lymphoma-2 (BCL-2).
When sonrotoclax blocks BCL-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with certain malignant diseases including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The start of treatment with BCL-2 inhibitor requires a gradual ramp-up over the first weeks to avoid potential consequences of initial tumor cell breakage and the release of cell content in the bloodstream.
Several ramp-up schedules have already been explored, and this study aims to optimize the dosing ramp-up schedule that may be beneficial to patients and caregivers. Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B-cell malignancies, including CLL and MCL.
This study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 17 months for treatment-naïve (TN) CLL participants or approximately 32 months for relapsed/refractory (R/R) MCL participants.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Stable ECOG Performance Status ≤ 2.
- Adequate organ function and no very recent transfusion or blood growth factor
- Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the last dose of zanubrutinib, whichever is later.
- Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
- At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
Exclusion criteria
- Participants unable to comply with the requirements of the protocol
- Serologic status reflecting active viral HBV or HCV infection
- Positive HIV serology (HIVAb) status unless certain conditions are met.
- Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
- Prior systemic treatment for the CLL
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT06697184
Intervention or treatment
DRUG: Sonrotoclax
DRUG: Zanubrutinib
Conditions
- Chronic Lymphocytic Leukemia
- CLL
- Mantle Cell Lymphoma
- MCL
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Blacktown Cancer and Haematology Centre
Select from list below to view details:
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Rockingham Hospital
Cooloongup, Western Australia, Australia
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Who is running the clinical trial?
BeiGene
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLL
| Drug: Sonrotoclax, Drug: Zanubrutinib |
EXPERIMENTAL: Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCL
| Drug: Sonrotoclax, Drug: Zanubrutinib |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience Tumor Lysis Syndrome (TLS) | TLS will be defined by Howard criteria during the schedule-limiting toxicity (SLT) evaluation window | Approximately 4 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 and tolerability as determined by protocol-defined Cs during the SLT evaluation window | Approximately 4 months |
| Number of Participants with Dose Modifications During the SLT Evaluation Window | Not Specified | Approximately 4 months |
References
Clinical Trials Gov: A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.Other trials to consider
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