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Orelabrutinib for B-Cell Malignancies
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently taking warfarin, vitamin K antagonists, or strong CYP3A inhibitors.I am 18 years old or older.I finished IV treatment for an infection less than 14 days ago.I haven't taken any chemotherapy or experimental drugs in the last 4 weeks.I have no lasting side effects from previous cancer treatments.I have taken medications that suppress my immune system.I have lymphoma in my brain or spinal cord.I am not allergic to Orelabrutinib or its ingredients and do not have HIV.I do not have any ongoing, uncontrolled infections.I am fully active or can carry out light work.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.I have a confirmed B-cell cancer, such as follicular lymphoma, marginal zone lymphoma, or CLL/SLL, with or without prior treatment.I have had an organ or stem-cell transplant, or I have progressive PML.I have or had a brain or spinal cord disease.I have not had major surgery or a significant injury in the last 28 days.I have not had another type of invasive cancer in the last 2 years.I have serious heart or lung disease.My organs are functioning well.I have previously received treatment with drugs that boost the immune system.I haven't had external beam radiation therapy in the last 6 weeks.
- Group 1: Part 2 Dose Expansion
- Group 2: Part 1 Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current capacity for accepting participants in this research?
"This medical trial necessitates the recruitment of 81 participants that meet certain admission criteria. Individuals have the opportunity to participate in this study at Clinical Research Alliance situated in New Hyde Park, NY and Goshen Center for Cancer Care positioned in Goshen, Indiana."
How many medical centers are currently conducting this research project in the urban area?
"30 recruitment sites are currently involved in this clinical trial, such as Clinical Research Alliance located in New Hyde Park, Goshen Center for Cancer Care found in Goshen and Summit Medical Group stationed at Florham Park. Additionally, there are an additional 30 participating institutions."
Has this investigative research ever been undertaken before?
"In 59 cities and 4 countries, 14 distinct clinical trials are still active for Orelabrutinib (ICP-022). Beginning in 2019, Beijing InnoCare Pharma Tech Co., Ltd. sponsored a Phase 1 & 2 study of 81 participants which has since been concluded; however, 13 other studies remain underway."
What additional research has been done with Orelabrutinib (ICP-022)?
"Presently, there are 14 ongoing investigations into Orelabrutinib (ICP-022), two of which have advanced to the third stage. Of these 114 participating clinical trial centres, a few are placed in Guangzhou, Guangdong."
Is it still possible to enroll in this clinical investigation?
"Affirmative. It is evident from clinicaltrials.gov that this trial, which was launched on November 18th 2019 and last updated on September 21st 2022, is actively seeking participants. The medical study requires 81 patients to be recruited across 30 sites."
What aims is this trial attempting to achieve?
"This clinical trial is designed to assess the efficacy of ICP-022 in terms of incidence and severity of dose limiting toxicities (DLTs) up to 28 days, objective response rate (ORR) for part 1 Dose Escalation and Part 2 Dose Expansion, as well as duration of response (DOR). Secondary objectives include safety assessment based on treatment emergent adverse events."
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