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Alkylating agents

Rituxan + Bendamustine + PCI-32765 for Lymphoma

Q: What is the enrollment limit for this research endeavor?

At this time, recruitment for this experiment has been closed. Initially posted on December 7th 2011 and last modified June 27th 2022, the study is no longer actively seeking participants. If you are still looking for studies to join, there are currently 2,720 trials related to Waldenstrom macroglobulinemia and 599 involving BTK inhibitor PCI-32765 that require involvement.

Q: Has the Food and Drug Administration accepted PCI-32765 as a BTK inhibitor?

The safety of BTK inhibitor PCI-32765 was assessed to be a 1 as this is an early stage trial, so there are only scant datasets confirming both its efficacy and safety.

Q: Is the registration process still ongoing for this experiment?

This trial is not currently accepting recruits. It was initially published on December 7th 2011 and last modified June 27 2022. However, there are over 2500 studies for waldenstrom macroglobulinemia and nearly 600 trials testing BTK inhibitor PCI-32765 that presently need participants.

Q: What is the usual purpose of taking BTK inhibitor PCI-32765?

PCI-32765, a BTK inhibitor commonly used to treat dlbcl, can also be prescribed for other malignancies such as b-cell lymphomas and polyangium. Additionally, this medication has been found to have some benefit in terms of amino acid supplementation.

Q: Are there any historical accounts of BTK inhibitor PCI-32765 in scientific research?

At present, there are 599 active clinical trials researching BTK inhibitor PCI-32765. Out of those studies, 111 have progressed to Phase 3 testing. Ascoli Piceno in Provincia is the base for multiple studies however this treatment is being tested at 25413 different locations worldwide.

Phase 1

Waitlist Available

Research Sponsored by Kami Maddocks, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post treatment

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a new drug, PCI-32765, when given with two other drugs to treat patients with NHL that has come back.

Who is the study for?

This trial is for adults with certain types of B-cell non-Hodgkin lymphoma that have come back after treatment. They must weigh at least 40 kg, be fairly active (ECOG <=2), and agree to use birth control if they can have children. People who've had other cancers recently, serious illnesses, or major surgery aren't eligible. Also excluded are those with HIV/HBV/HCV infections, severe heart disease, or poor kidney/liver/blood function.Check my eligibility

What is being tested?

The trial tests a combination of treatments: the BTK inhibitor PCI-32765 with rituximab and bendamustine hydrochloride in patients whose lymphoma has returned. It aims to find the safest dose that works best by blocking cancer cell growth enzymes and attacking cancer cells directly.See study design

What are the potential side effects?

Possible side effects include reactions related to infusion such as fever or chills; low blood counts leading to increased infection risk; liver problems; fatigue; digestive issues like nausea or constipation; muscle and bone pain; and potential heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose (MTD) as determined by the incidence of dose limiting toxicities (DLT) of BTK inhibitor PCI-32765 when given in combination with rituximab and bendamustine hydrochloride

Secondary outcome measures

Correlation of PGx with response and toxicity

Duration of response

Frequency, severity, and relatedness of adverse events

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (enzyme inhibitor, chemo, monoclonal antibody)Experimental Treatment6 Interventions

Patients receive BTK inhibitor PCI-32765 PO QD on days 1-28. Patients also receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue receiving BTK inhibitor PCI-32765 PO in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bendamustine hydrochloride

2010

Completed Phase 2

~370

rituximab

2000

Completed Phase 3

~2760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kami Maddocks, MDLead Sponsor

2 Previous Clinical Trials

172 Total Patients Enrolled

1 Trials studying Waldenstrom Macroglobulinemia

18 Patients Enrolled for Waldenstrom Macroglobulinemia

Pharmacyclics LLC.Industry Sponsor

113 Previous Clinical Trials

13,772 Total Patients Enrolled

5 Trials studying Waldenstrom Macroglobulinemia

1,161 Patients Enrolled for Waldenstrom Macroglobulinemia

Kami MaddocksLead Sponsor

3 Previous Clinical Trials

174 Total Patients Enrolled

2 Trials studying Waldenstrom Macroglobulinemia

20 Patients Enrolled for Waldenstrom Macroglobulinemia

Frequently Asked Questions

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

What is the enrollment limit for this research endeavor?

"At this time, recruitment for this experiment has been closed. Initially posted on December 7th 2011 and last modified June 27th 2022, the study is no longer actively seeking participants. If you are still looking for studies to join, there are currently 2,720 trials related to Waldenstrom macroglobulinemia and 599 involving BTK inhibitor PCI-32765 that require involvement."

Answered by AI

Has the Food and Drug Administration accepted PCI-32765 as a BTK inhibitor?

"The safety of BTK inhibitor PCI-32765 was assessed to be a 1 as this is an early stage trial, so there are only scant datasets confirming both its efficacy and safety."

Answered by AI

Is the registration process still ongoing for this experiment?

"This trial is not currently accepting recruits. It was initially published on December 7th 2011 and last modified June 27 2022. However, there are over 2500 studies for waldenstrom macroglobulinemia and nearly 600 trials testing BTK inhibitor PCI-32765 that presently need participants."

Answered by AI

What is the usual purpose of taking BTK inhibitor PCI-32765?

"PCI-32765, a BTK inhibitor commonly used to treat dlbcl, can also be prescribed for other malignancies such as b-cell lymphomas and polyangium. Additionally, this medication has been found to have some benefit in terms of amino acid supplementation."

Answered by AI

Are there any historical accounts of BTK inhibitor PCI-32765 in scientific research?

"At present, there are 599 active clinical trials researching BTK inhibitor PCI-32765. Out of those studies, 111 have progressed to Phase 3 testing. Ascoli Piceno in Provincia is the base for multiple studies however this treatment is being tested at 25413 different locations worldwide."

Answered by AI

Recent research and studies

BloodJournal

A Phase 1/1b Study of Rituximab, Bendamustine, and Ibrutinib in Patients with Untreated and Relapsed/refractory Non-hodgkin Lymphoma

Maddocks, Kami, Beth Christian, Samantha Jaglowski, Joseph Flynn, Jeffery A. Jones, Pierluigi Porcu, Lai Wei, et al.. 2015. “A Phase 1/1b Study of Rituximab, Bendamustine, and Ibrutinib in Patients with Untreated and Relapsed/refractory Non-hodgkin Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood-2014-08-597914.

clinicaltrials.govStudy

Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma

Kami Maddocks, MD 2011. "Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01479842.

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