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Alkylating agents

Ibrutinib for Diffuse Large B-Cell Lymphoma

Phase 2

Waitlist Available

Led By Jason Westin

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether giving rituximab, ibrutinib, and lenalidomide with chemotherapy is more effective at treating high-risk diffuse large B-cell lymphoma than just giving chemotherapy.

Eligible Conditions

Diffuse Large B-Cell Lymphoma Unclassifiable

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Secondary outcome measures

Overall Survival for 2 Years

Progression Free Survival at 2 Years

Trial Design

2Treatment groups

Experimental Treatment

Group I: RLI WITH R-CHOPExperimental Treatment7 Interventions

SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: RLI WITH EPOCHExperimental Treatment8 Interventions

SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive etoposide IV over 24 hours on days 1-4, prednisone PO QD on days 1-5, vincristine sulfate IV over 24 hours on days 1-4, doxorubicin hydrochloride IV over 24 hours on days 1-4, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 3

~1880

Cyclophosphamide

1995

Completed Phase 3

~3770

Etoposide

2010

Completed Phase 3

~2440

Lenalidomide

2005

Completed Phase 3

~1480

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Rituximab

1999

Completed Phase 4

~1880

Prednisone

2014

Completed Phase 4

~2370

Vincristine Sulfate

2005

Completed Phase 3

~10110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,261 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,926,013 Total Patients Enrolled

Jason WestinPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

113 Total Patients Enrolled

Frequently Asked Questions

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

Have any other scholarly investigations been conducted on Ibrutinib?

"Currently, the scientific community is exploring Ibrutinib through 1940 active trials. Of these investigations, 422 are in Phase 3 and most of them originate from Ascoli Piceno, Provincia; however there are 75275 locations worldwide carrying out such research."

Answered by AI

What is the current recruitment rate for this experiment?

"Unfortunately, this research project is no longer recruiting participants. It was first published on March 29th 2016 and last modified February 23rd 2022. For those looking for other studies to participate in, there are 1765 studies actively admitting patients with lymphoma B-cell related issues and another 1940 trials that accept volunteers using Ibrutinib as a treatment option."

Answered by AI

What medical conditions is Ibrutinib commonly administered to address?

"Ibrutinib is commonly prescribed to patients with prostate cancer, but also has potential efficacy in treating other medical issues such as pheochromocytomas, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

What safety considerations should be taken into account when administering Ibrutinib?

"Our team at Power gauged the safety of Ibrutinib as a 2, given that this is only Phase 2 and while there has been some data collection on its efficacy none yet supports it."

Answered by AI

Is there presently any recruitment for this experiment?

"Although the original posting of this medical trial was on March 29th 2016, a recent review of clinicaltrials.gov shows that it is not presently seeking volunteers for its research. Fortunately, there are other trials actively recruiting patients at the present time- 3705 in total."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Smart Start: Rituximab, Lenalidomide, and Ibrutinib in Patients with Newly Diagnosed Large B-cell Lymphoma

Westin, Jason, R. Eric Davis, Lei Feng, Fredrick Hagemeister, Raphael Steiner, Hun Ju Lee, Luis Fayad, et al.. 2022. “Smart Start: Rituximab, Lenalidomide, and Ibrutinib in Patients with Newly Diagnosed Large B-cell Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.22.00597.

clinicaltrials.govStudy

Smart Start: A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib

2016. "Smart Start: A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02636322.