Rituximab for B-Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hospital Universitari Germans Trias i Pujol ICO Badalona, Barcelona, SpainB-Cell LymphomaRituximab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing two new drugs, CC-220 and CC-99282, to see if they are effective in treating a-BCL (a type of cancer). The trial has two parts: first, a dose escalation to find the best dose of the new drugs to use, and second, a randomized expansion to test the new drugs at the recommended dose.

Eligible Conditions
  • B-Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 27 Secondary · Reporting Duration: Up to 4 years

Day 21
Pharmacokinetics - AUC for CC-220
Pharmacokinetics - AUC for CC-99282
Pharmacokinetics - CL/F for CC-220
Pharmacokinetics - CL/F for CC-99282
Pharmacokinetics - V/F for CC-220
Pharmacokinetics - V/F for CC-99282
Pharmacokinetics - tmax for CC-220
Pharmacokinetics - tmax for CC-99282
Pharmacokinetics - t½ for CC-220
Pharmacokinetics - t½ for CC-99282
Day 21
Pharmacokinetics - AUC (TAU) for CC-220
Pharmacokinetics - AUC (TAU) for CC-99282
Pharmacokinetics - CLT/F for CC-220
Pharmacokinetics - CLT/F for CC-99282
Pharmacokinetics - Cmax for CC-99282
Pharmacokinetics - Ctrough for CC-220
Pharmacokinetics - Ctrough for CC-99282
Pharmacokinetics - Tmax for CC-220
Pharmacokinetics - Tmax for CC-99282
Day 21
Pharmacokinetics - Cmax for CC-220
Day 21
Maximum Tolerated Dose (MTD) - Part 1
Maximum Tolerated Dose (MTD) - Part 2A
Recommended Phase 2 Dose (RP2D) - Part 1
Recommended Phase 2 Dose (RP2D) - Part 2A
Day 28
Incidence of Adverse Events (AEs)
Day 28
Safety and tolerability of CC-220 and CC-99282 at RP2D - Part 2
Up to 4 years
Best overall response rate (ORR)
Complete Metabolic Response Rate (CMRR)
Duration of Response (DOR)
Overall Survival (OS)
Progression-free Survival (PFS)
Time to Response (TTR)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Administration of CC-220 with R-CHOP-21
1 of 4
Administration of CC-99282 with polatuzumab-R-CHP
1 of 4
Administration of CC-220 with polatuzumab-R-CHP
1 of 4
Administration of CC-99282 with R-CHOP-21
1 of 4

Experimental Treatment

174 Total Participants · 4 Treatment Groups

Primary Treatment: Rituximab · No Placebo Group · Phase 1

Administration of CC-220 with R-CHOP-21Experimental Group · 6 Interventions: CC-220, Doxorubicin, Cyclophosphamide, Rituximab, Vincristine, Prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Administration of CC-99282 with polatuzumab-R-CHPExperimental Group · 6 Interventions: Polatuzumab vedotin, Doxorubicin, Cyclophosphamide, Rituximab, Prednisone, CC-99282 · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Administration of CC-220 with polatuzumab-R-CHPExperimental Group · 6 Interventions: Polatuzumab vedotin, CC-220, Doxorubicin, Cyclophosphamide, Rituximab, Prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Administration of CC-99282 with R-CHOP-21Experimental Group · 6 Interventions: Doxorubicin, Cyclophosphamide, Rituximab, Vincristine, Prednisone, CC-99282 · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-220
Not yet FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Rituximab
FDA approved
Vincristine
FDA approved
Prednisolone
FDA approved
CC-99282
2017
Completed Phase 2
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

CelgeneLead Sponsor
625 Previous Clinical Trials
122,945 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,416 Previous Clinical Trials
3,311,137 Total Patients Enrolled
Vijaya Kesanakurthy, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
47 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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Frequently Asked Questions

Are there various facilities in the United States that are facilitating this clinical study?

"This medical trial has been approved to operate out of the Mayo Clinic Jacksonville - PPDS in Jacksonville, Florida, Mayo Clinic Rochester in Minnesota and Vanderbilt University Medical Center in Tennessee. Additionally, there are 10 more sites across America authorized for recruitment." - Anonymous Online Contributor

Unverified Answer

Are there any recruitment opportunities for this medical experiment?

"Clinicaltrials.gov provides evidence that this clinical trial is still in search of participants, having been initially published on September 15th 2021 and last updated October 11th 2022." - Anonymous Online Contributor

Unverified Answer

Is there a documented history of research with Rituximab?

"Since 1993, there have been 2583 studies conducted on the efficacy of rituximab from National Institutes of Health Clinical Center in Rockville Pike. Presently, 1478 trials are still ongoing with many based out of Jacksonville, Florida." - Anonymous Online Contributor

Unverified Answer

What goals is the trial attempting to attain?

"According to Celgene, the primary objective of this clinical trial will be measured in a 21-day time period and is focused on safety and tolerance for CC-220 and CC-99282. Aside from the main aim, researchers are assessing other pharmacokinetic parameters such as Area under the plasma concentration-time curve (AUC), Time to maximum plasma concentration (Tmax) and Apparent volume of distribution (V/F)." - Anonymous Online Contributor

Unverified Answer

What impact does Rituximab have on a person's overall health?

"As it is a Phase 1 clinical trial, our team at Power rates Rituximab's safety as low (1), due to limited evidence of its effectiveness and safety." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment size for this investigation?

"Celgene, the sponsor of this trial, needs 116 qualified participants to proceed. The study will be conducted in both Mayo Clinic Jacksonville - PPDS situated in Jacksonville, Florida and Mayo Clinic Rochester located in Minnesota's largest city." - Anonymous Online Contributor

Unverified Answer

How is Rituximab usually deployed to treat patients?

"Rituximab is widely used to treat ulcerative colitis and has also been shown to be effective in the management of conditions like acute retinal necrosis due to varicella-zoster virus, multiple myeloma, and tuberculous meningitis." - 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.