Pre-Modulation Treatment for Non-Hodgkin's Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Moffitt Cancer Center, Tampa, FLNon-Hodgkin's LymphomaItacitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the safety and effectiveness of a new medicine to treat DLBCL before receiving CAR-T cell therapy.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Treatment (siltuximab, biospecimen)
1
LMY-920 dose escalation
1
Radiation Therapy Before CAR T Cell Therapy

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: up to 27months

Up to 3 months
Incidence of Severe Cytokine Release Syndrome (CRS)
Incidence of Severe Immune efflector cell Associated Neurotoxicity Syndrome (ICANS)
at 6 months
Overall Response Rate
up to 27 months
Progression Free Survival (PFS)
up to 27months
Overall Survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Treatment (siltuximab, biospecimen)
1
LMY-920 dose escalation
1
Radiation Therapy Before CAR T Cell Therapy

Trial Design

1 Treatment Group

Pre-Modulation Treatment
1 of 1

Experimental Treatment

27 Total Participants · 1 Treatment Group

Primary Treatment: Pre-Modulation Treatment · No Placebo Group · Phase 2

Pre-Modulation TreatmentExperimental Group · 2 Interventions: Itacitinib, Chimeric antigen receptor (CAR) T-cell therapy · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2018
Completed Phase 3
~790

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 27months

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
510 Previous Clinical Trials
126,925 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
323 Previous Clinical Trials
46,994 Total Patients Enrolled
Michael Jain, MD, PhDPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Has Pre-Modulation Treatment obtained regulatory approval from the FDA?

"Pre-Modulation Treatment received a score of 2 on Power's safety scale, as Phase 2 trials provide some evidence for its safety but no concrete proof yet that it is efficacious." - Anonymous Online Contributor

Unverified Answer

Are there any available vacancies to join this research project?

"Indeed, clinicaltrials.gov confirms that this medical experiment is still seeking participants. The trial was initially uploaded on February 23rd 2023 and most recently revised on the following day. 27 volunteers are needed from a single enrolment location." - Anonymous Online Contributor

Unverified Answer

How many individuals have participated in this clinical experiment?

"Affirmative, data hosted on clinicaltrials.gov shows that this medical trial is still identifying potential participants. It was first published on February 23rd 2023 and last updated a day later. The research team are currently looking for 27 individuals from 1 site." - 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.

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