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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518829-15-00 | EU Trial (CTIS) Number |
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The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLL | Experimental | Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol. The total treatment duration is of 15 cycles of 28 days (including the phase of sonrotoclax dose ramp-up) |
|
| Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCL | Experimental | Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol, for a total of 27 cycles of 28 days (including the phase of sonrotoclax ramp-up), then will continue on zanubrutinib alone until progression of their disease or other treatment discontinuation criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonrotoclax | Drug | Administered orally |
|
| 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 | Up to approximately 4 months |
| 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 | Up to approximately 4 months |
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Inclusion Criteria:
Stable Eastern Cooperative Oncology Group (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 ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.
Only for participants with Chronic Lymphocytic Leukemia (CLL):
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.
Only for participants with Mantle cell lymphoma (MCL):
Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).
Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.
Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter.
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 1.877.828.5568 | clinicaltrials@beonemed.com | |
| Study Director | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Active, not recruiting | Tampa | Florida | 33612-9496 | United States | |
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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|
| Zanubrutinib | Drug | Administered orally |
|
|
| Number of Participants with Dose Modifications During the SLT Evaluation Window | Up to approximately 4 months |
| Fort Wayne Medical Oncology and Hematology |
| Active, not recruiting |
| Fort Wayne |
| Indiana |
| 46804 |
| United States |
| The University of Kansas Cancer Center | Active, not recruiting | Westwood | Kansas | 66205-2003 | United States |
| Dana Farber Cancer Institute | Active, not recruiting | Boston | Massachusetts | 02215-5418 | United States |
| Washington University School of Medicine | Active, not recruiting | St Louis | Missouri | 63110-1010 | United States |
| Fred Hutchinson Cancer Research Center | Active, not recruiting | Seattle | Washington | 98109-4433 | United States |
| Blacktown Cancer and Haematology Centre | Recruiting | Blacktown | New South Wales | NSW 2148 | Australia |
| Genesiscare St Andrews | Recruiting | Adelaide | South Australia | SA 5000 | Australia |
| Cabrini Hospital Malvern | Recruiting | Malvern | Victoria | VIC 3144 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | VIC 3004 | Australia |
| Rockingham Hospital | Recruiting | Cooloongup | Western Australia | WA 6168 | Australia |
| Linear Clinical Research | Recruiting | Nedlands | Western Australia | WA 6009 | Australia |
| Chu Dijon | Active, not recruiting | Dijon | 21000 | France |
| Chu Montpellier Hopital Saint Eloi | Active, not recruiting | Montpellier | 34090 | France |
| Iuct Oncopole | Active, not recruiting | Toulouse | 31100 | France |
| Queen Elizabeth Hospital | Active, not recruiting | Birmingham | B15 2TH | United Kingdom |
| St Jamess University Hospital | Active, not recruiting | Leeds | LS9 7TF | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
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