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A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL

I

InnoCare Pharma

Status and phase

Not yet enrolling
Phase 3

Conditions

Mantle Cell Lymphoma

Treatments

Drug: Rituximab
Drug: Bendamustine Injection
Drug: Orelabrutinib Placebo
Drug: Orelabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06363994
ICP-CL-00128

Details and patient eligibility

About

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

Enrollment

490 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

490 participants in 3 patient groups, including a placebo group

Arm A
Active Comparator group
Treatment:
Drug: Rituximab
Drug: Bendamustine Injection
Drug: Orelabrutinib
Arm B
Active Comparator group
Treatment:
Drug: Orelabrutinib Placebo
Drug: Rituximab
Drug: Bendamustine Injection
Drug: Orelabrutinib
Arm C
Placebo Comparator group
Treatment:
Drug: Orelabrutinib Placebo
Drug: Rituximab
Drug: Bendamustine Injection

Trial contacts and locations

0

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Central trial contact

Alexia Lu

Data sourced from clinicaltrials.gov

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