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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Rituximab + Chemotherapy for Mantle Cell Lymphoma

Q: Are individuals aged 55 and above eligible for the current research protocol?

To be part of this clinical trial, potential participants must between 18 and 65 years old. There are 767 trials for minors, and 3246 studies for seniors.

Q: Has the FDA sanctioned Rituximab for therapeutic use?

The safety of Rituximab was determined to be a 2 due to its Phase 2 trial status, which implies that while there is evidence of its security profile, no data exists attesting to the drug's efficacy.

Q: To what medical ailments is Rituximab most often prescribed?

Rituximab is regularly used to manage <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, but can also be prescribed for synovitis, ophthalmia, sympathetic nerve problems and lung cancers.

Q: Could I theoretically take part in this investigation?

This medical trial is looking to enrol 131 subjects suffering from pleomorphic variant <a href="https://www.withpower.com/clinical-trials/mantle-cell-lymphoma">mantle cell lymphoma</a> and aged between 18-65. The key criteria for application are: documented evidence of CD20 positvity in tissue biopsy, a Mantle Cell International Prognostic Score (MIPI) higher than 3, Ki-67 levels above 30%, risk of organ dysfunction due to the disease, raised LDH concentrations, PB WBC count over 50K and bulky tumours measuring 7 cm or more if there are two or more with diameters exceeding 5cm each.

Q: How many participants can this research effort accommodate?

At the moment, this trial is not currently seeking enrolment. It was first posted on June 3rd 2015 and last edited August 30th 2022. For those searching for other medical studies, there are 1720 trials with pleomorphic variant <a href="https://www.withpower.com/clinical-trials/mantle-cell-lymphoma">mantle cell lymphoma</a> actively recruiting participants and 2033 research programs utilizing Rituximab that require patients.

Q: Is this research initiative still accepting participants?

The findings on clinicaltrials.gov demonstrate that this research trial is no longer recruiting participants as it was previously posted in June 2015 and last updated in August 2022. Despite the conclusion of recruitment for this particular experiment, there are still 3753 other investigations actively seeking patients at present.

Q: Are there any documented accounts of Rituximab being utilized in prior research?

Currently, there are 2033 research projects related to Rituximab in progress. Of these initiatives, 436 have reached Phase 3, with the majority located near Ascoli Piceno, Provincia. Globally speaking however, 66825 study sites exist for this particular drug.

Phase 2

Waitlist Available

Led By Luhua (Michael) Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age =< 65 years at the time of signing the informed consent

Patients should have bi-dimensional measurable disease using the Cheson criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study Summary

This trial is testing ibrutinib, rituximab, and consolidation chemotherapy as a treatment for mantle cell lymphoma in young patients.

Who is the study for?

This trial is for young patients under 65 with newly diagnosed mantle cell lymphoma, who need immediate treatment and have measurable disease. They should be in good physical condition (ECOG <=2), have proper organ function, no serious medical conditions or active infections, and not be pregnant. High-risk factors like blastoid/pleomorphic variant or certain genetic mutations qualify them.Check my eligibility

What is being tested?

The study tests a combination of the drug Ibrutinib with Rituximab and other chemotherapy drugs to see if they work better together for treating mantle cell lymphoma. It aims to block cancer growth enzymes, help the immune system attack cancer cells, and kill or stop cancer cells from dividing.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to therapy, blood disorders due to bone marrow impact, liver issues reflected by bilirubin levels, heart problems shown by ejection fraction rates, fatigue from overall treatment burden.

Eligibility Criteria

Inclusion Criteria

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

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I am 65 years old or younger.

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My cancer can be measured in two dimensions.

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I can take care of myself but cannot do heavy physical work.

Select...

My kidneys are functioning well enough to clear at least 30 mL/min.

Select...

My biopsy shows I have mantle cell lymphoma with CD20 positive.

Select...

I have aggressive MCL with symptoms needing immediate treatment.

Select...

I have a newly diagnosed condition and have not received any treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (complete response + partial response)

Secondary outcome measures

Incidence of adverse events

Overall survival

Progression free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib, rituximab, consolidation chemotherapy)Experimental Treatment11 Interventions

PART I (IBRUTINIB PLUS RITUXIMAB): Patients receive ibrutinib PO QD on days 1-28 and rituximab IV over 6-8 hours on days 1, 8, 15, and 22 of cycle 1 and then over 4 hours on day 1 of cycles 3-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or until patients achieve complete response. PART II (CONSOLIDATION THERAPY): Patients receive rituximab IV over 6 hours on day 1; dexamethasone PO or IV on days 1-4; cyclophosphamide IV over 3 hours BID on days 2-4; doxorubicin hydrochloride IV over 15-30 minutes on day 5; and vincristine sulfate IV over 15-30 minutes on day 5 of cycles 1, 3, 5, and 7. Patients also receive rituximab IV over 6 hours on day 1; methotrexate IV over 24 hours on day 2; and cytarabine IV over 2 hours BID on days 3 and 4 of cycles 2, 4, 6, and 8. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Dexamethasone

2007

Completed Phase 4

~2590

Methotrexate

2013

Completed Phase 4

~3800

Rituximab

1999

Completed Phase 4

~1880

Ibrutinib

2014

Completed Phase 3

~1880

Vincristine

2003

Completed Phase 4

~2910

Vincristine Sulfate

2005

Completed Phase 3

~10110

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Doxorubicin

2012

Completed Phase 3

~7940

Cyclophosphamide

1995

Completed Phase 3

~3780

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,650 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,022 Total Patients Enrolled

Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center

14 Previous Clinical Trials

499 Total Patients Enrolled

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02427620 — Phase 2

Mantle Cell Lymphoma Research Study Groups: Treatment (ibrutinib, rituximab, consolidation chemotherapy)

Mantle Cell Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02427620 — Phase 2

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02427620 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 55 and above eligible for the current research protocol?

"To be part of this clinical trial, potential participants must between 18 and 65 years old. There are 767 trials for minors, and 3246 studies for seniors."

Answered by AI

Has the FDA sanctioned Rituximab for therapeutic use?

"The safety of Rituximab was determined to be a 2 due to its Phase 2 trial status, which implies that while there is evidence of its security profile, no data exists attesting to the drug's efficacy."

Answered by AI

To what medical ailments is Rituximab most often prescribed?

"Rituximab is regularly used to manage leukemia, but can also be prescribed for synovitis, ophthalmia, sympathetic nerve problems and lung cancers."

Answered by AI

Could I theoretically take part in this investigation?

"This medical trial is looking to enrol 131 subjects suffering from pleomorphic variant mantle cell lymphoma and aged between 18-65. The key criteria for application are: documented evidence of CD20 positvity in tissue biopsy, a Mantle Cell International Prognostic Score (MIPI) higher than 3, Ki-67 levels above 30%, risk of organ dysfunction due to the disease, raised LDH concentrations, PB WBC count over 50K and bulky tumours measuring 7 cm or more if there are two or more with diameters exceeding 5cm each."

Answered by AI

How many participants can this research effort accommodate?

"At the moment, this trial is not currently seeking enrolment. It was first posted on June 3rd 2015 and last edited August 30th 2022. For those searching for other medical studies, there are 1720 trials with pleomorphic variant mantle cell lymphoma actively recruiting participants and 2033 research programs utilizing Rituximab that require patients."

Answered by AI

Is this research initiative still accepting participants?

"The findings on clinicaltrials.gov demonstrate that this research trial is no longer recruiting participants as it was previously posted in June 2015 and last updated in August 2022. Despite the conclusion of recruitment for this particular experiment, there are still 3753 other investigations actively seeking patients at present."

Answered by AI

Are there any documented accounts of Rituximab being utilized in prior research?

"Currently, there are 2033 research projects related to Rituximab in progress. Of these initiatives, 436 have reached Phase 3, with the majority located near Ascoli Piceno, Provincia. Globally speaking however, 66825 study sites exist for this particular drug."

Answered by AI

Recent research and studies

British Journal of HaematologyJournal

Four-year Follow-up of a Single Arm, Phase II Clinical Trial of Ibrutinib with Rituximab (IR) in Patients with Relapsed/refractory Mantle Cell Lymphoma (MCL)

Jain, Preetesh, Jorge Romaguera, Samer A. Srour, Hun J. Lee, Frederick Hagemeister, Jason Westin, Luis Fayad, et al.. 2018. “Four-year Follow-up of a Single Arm, Phase II Clinical Trial of Ibrutinib with Rituximab (IR) in Patients with Relapsed/refractory Mantle Cell Lymphoma (MCL)”. British Journal of Haematology. Wiley. doi:10.1111/bjh.15411.

Journal of Clinical OncologyJournal

Ibrutinib with Rituximab in First-line Treatment of Older Patients with Mantle Cell Lymphoma

Jain, Preetesh, Shuangtao Zhao, Hun Ju Lee, Holly A. Hill, Chi Young Ok, Rashmi Kanagal-Shamanna, Fredrick B. Hagemeister, et al.. 2022. “Ibrutinib with Rituximab in First-line Treatment of Older Patients with Mantle Cell Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01797.

The Lancet OncologyJournal

Ibrutinib–rituximab Followed by R-HCVAD as Frontline Treatment for Young Patients (≤65 Years) with Mantle Cell Lymphoma (WINDOW-1): A Single-arm, Phase 2 Trial

Wang, Michael L, Preetesh Jain, Shuangtao Zhao, Hun Ju Lee, Loretta Nastoupil, Luis Fayad, Chi Young Ok, et al.. 2022. “Ibrutinib–rituximab Followed by R-HCVAD as Frontline Treatment for Young Patients (≤65 Years) with Mantle Cell Lymphoma (WINDOW-1): A Single-arm, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00638-0.

clinicaltrials.govStudy