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NCT04884035 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
A Phase 1 study of Lymphoma, B-Cell, sponsored by Celgene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 174
- Enrollment target
- 20
- Study locations
NCT04884035: Recruiting Phase 1 study of Lymphoma, B-Cell, sponsored by Celgene.
NCT04884035 is a Phase 1 study of Lymphoma, B-Cell that is actively recruiting participants, run by Celgene. The registered enrollment target is 174 participants, below the 196-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04884035, a Phase 1 study of Lymphoma, B-Cell, is actively recruiting participants, sponsored by Celgene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 174 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined.
Primary Outcome
Frequency of dose-limiting toxicities (DLT) associated with addition of iberdomide (CC-220) to R-CHOP-21 therapy and the addition of CC-99282 to R-CHOP-21 therapy
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Vincristine
- DRUG CC-220
Study Locations (20)
Other
- Local Institution - 503 - Perth
- Local Institution - 502 - Waratah
- Evangelismos General Hospital of Athens - Athens
- General Hospital of Athens "Laiko" - Athens
- Attikon University General Hospital - Athens
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- Mayo Clinic Jacksonville - PPDS - Jacksonville
Kansas
- University Of Kansas Medical Center - Kansas City
- Cancer Center Of Kansas-Wichita - Wichita
Minnesota
- Mayo Clinic - Rochester - Rochester
- HealthPartners Cancer Research Center - Saint Louis Park
Utah
- Local Institution - 168 - Murray
- Local Institution - 171 - St. George
Arizona
- Mayo Clinic - Arizona - Scottsdale
California
- Local Institution - 169 - Duarte
Nebraska
- University of Nebraska - Fred and Pamela Buffet Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 1 |
What NCT04884035 shows while recruiting
NCT04884035 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 196-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Lymphoma, B-Cell appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04884035 names 20 study sites across 12 states, led by Other, Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT04884035 about?
NCT04884035 is a clinical study titled "Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma". This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincr...
What is the current status of trial NCT04884035?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2021-09-15. Estimated completion is 2028-12-01.
What conditions does trial NCT04884035 study?
This clinical trial studies the following conditions: Lymphoma, B-Cell.
What interventions are being tested in trial NCT04884035?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG), CC-220 (DRUG).
Who is sponsoring clinical trial NCT04884035?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04884035 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma, B-Cell
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04884035's enrollment target sits among peer trials
174 8th of 31 higher than 24 of 31 other Lymphoma, B-Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, B-Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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