BMS-986403 for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Local Institution - 0034, Bergamo, ItalyLymphoma+1 MoreBMS-986403 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for people with leukemia or lymphoma who have not responded to other treatments.

Eligible Conditions
  • Lymphoma
  • Chronic B-Cell Leukemia

Treatment Effectiveness

Study Objectives

6 Primary · 11 Secondary · Reporting Duration: Up to 2 years after BMS-986403 infusion

Year 2
Complete remission rate (CRR)
Duration of complete remission (DOCR)
Duration of response (DOR)
Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period
Number of participants with adverse events (AEs)
Number of participants with clinical laboratory abnormalities
Number of participants with dose-limiting toxicity (DLT)
Number of participants with serious adverse events (SAEs)
Overall response rate (ORR)
Overall survival (OS)
Pharmacokinetics by PCR: Area under the curve (AUC)
Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)
Inverse PCR
Progression free survival (PFS)
Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Time to CR (TTCR)
Time to response (TTR)

Trial Safety

Trial Design

1 Treatment Group

BMS-986403 + Fludarabine + Cyclophosphamide
1 of 1

Experimental Treatment

65 Total Participants · 1 Treatment Group

Primary Treatment: BMS-986403 · No Placebo Group · Phase 1

BMS-986403 + Fludarabine + CyclophosphamideExperimental Group · 3 Interventions: BMS-986403, Fludarabine, Cyclophosphamide · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3920

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after bms-986403 infusion

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,510 Previous Clinical Trials
3,944,278 Total Patients Enrolled
54 Trials studying Lymphoma
6,126 Patients Enrolled for Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

What is the upper-limit of participants in this experiment?

"Affirmative. Information from clinicaltrials.gov denotes that this research is currently enrolling patients, with the trial having been first uploaded on September 14th 2022 and last modified on September 29th 2022. The medical study requires 65 volunteers across 18 sites to meet its recruitment goals." - Anonymous Online Contributor

Unverified Answer

Are there still positions available for volunteers in this experiment?

"Clinicaltrials.gov reveals that this experiment is presently recruiting participants, with the study first posted on September 14th and most recently amended on September 29th." - Anonymous Online Contributor

Unverified Answer

What are the potential risks associated with administering BMS-986403 to patients?

"Since BMS-986403 is currently in its first phase of clinical trials, there are limited data regarding the drug's efficacy and safety. Subsequently, our team graded this medication a 1 on our scale from 1 to 3." - Anonymous Online Contributor

Unverified Answer

Are there any Canadian research centers which are currently conducting this clinical trial?

"18 different medical centres are currently involved in the clinical trial, including The Ohio State University Wexner Medical Centre James Cancer Hospital in Columbus, Massachusetts General Hospital-Medical Oncology in Boston and a Local Institution based out of Seattle. Additionally, there is an assortment of other locations participating as well." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.