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Tyrosine Kinase Inhibitor

Orelabrutinib for B-Cell Malignancies

Phase 1 & 2

Waitlist Available

Research Sponsored by Beijing InnoCare Pharma Tech Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

ECOG performance status of 0 ~1

Must not have

Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor

History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The first part will test different doses to see what is safe. The second part will test how well the drug works.

Who is the study for?

This trial is for adults over 18 with certain B-cell malignancies, like relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Participants need to have a life expectancy of at least 4 months, be in good physical condition, and not have active hepatitis or HIV. Pregnant women and those who've had recent major surgeries or other cancer treatments are excluded.

What is being tested?

The study tests Orelabrutinib's safety and effectiveness in two parts: dose escalation to find the right amount of drug that can be given safely, followed by dose expansion to further assess its effects on patients with specific types of B-cell malignancies.

What are the potential side effects?

While the exact side effects aren't listed here, similar drugs often cause issues like diarrhea, bleeding problems, high blood pressure, fatigue, muscle & bone pain. There may also be risks from lowered immune function leading to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I have a relapsed or hard-to-treat B-cell cancer such as follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking warfarin, vitamin K antagonists, or strong CYP3A inhibitors.

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I have had an organ or stem-cell transplant, or I have progressive PML.

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I finished IV treatment for an infection less than 14 days ago.

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I have or had a brain or spinal cord disease.

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I have no lasting side effects from previous cancer treatments.

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I have taken medications that suppress my immune system.

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I have lymphoma in my brain or spinal cord.

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I am not allergic to Orelabrutinib or its ingredients and do not have HIV.

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I do not have any ongoing, uncontrolled infections.

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I have not had another type of invasive cancer in the last 2 years.

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I have serious heart or lung disease.

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I have previously received treatment with drugs that boost the immune system.

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I haven't had external beam radiation therapy in the last 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 Dose Escalation：The maximum tolerated dose (MTD)

Part 2 Dose Expansion：ORR

Secondary study objectives

Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]

Part 1 Dose Escalation：ORR

Part 1 Dose Escalation：T1/2

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose ExpansionExperimental Treatment1 Intervention

Arm 1: Patients with r/r MCL Arm 2: Patients with other types of B-cell malignancies, including: * CLL/SLL with/without prior treatment * r/r FL * r/r MZL

Group II: Part 1 Dose EscalationExperimental Treatment1 Intervention

Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL

0 / 16Eligibility criteria met