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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06363994
Other study ID # ICP-CL-00128
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 25, 2024
Est. completion date December 25, 2035

Study information

Verified date April 2024
Source InnoCare Pharma Inc.
Contact Alexia Lu
Phone 010-66609745
Email CO_HGRAC@innocarepharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 490
Est. completion date December 25, 2035
Est. primary completion date December 25, 2034
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Subjects who are = 60 years old and are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior therapies (including surgery for therapeutic purposes, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) for MCL. 2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator. 3. Histopathological confirmed MCL. 4. At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm). 5. ECOG PS score of 0 to 2. Exclusion Criteria: 1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening. 2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy. 3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant. 4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study. 5. Known central nervous system lymphoma.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol,until disease progression or other reasons for treatment discontinuation,whichever comes first.
Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Orelabrutinib Placebo
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
InnoCare Pharma Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity (DLT) 28 days
Primary Progression-free Survival (PFS) for Arm A vs. Arm C Approximately 10 years
See also
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Recruiting NCT05471843 - Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma Phase 1/Phase 2
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Active, not recruiting NCT03891355 - Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL Phase 2
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Terminated NCT03585725 - A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma Early Phase 1
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Completed NCT01665768 - Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Phase 2
Completed NCT01437709 - Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant Phase 2
Completed NCT00963534 - Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. Phase 1/Phase 2
Completed NCT00921414 - Mantel Cell Lymphoma Efficacy of Rituximab Maintenance Phase 3
Withdrawn NCT00541424 - Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma N/A
Completed NCT01456351 - Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab Phase 3
Completed NCT01851551 - Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL Phase 1/Phase 2
Completed NCT03295240 - The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma Early Phase 1