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NCT05222555 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
A Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Incyte Corporation.
- Active
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 20
- Study locations
NCT05222555: Active Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Incyte Corporation.
NCT05222555 is a Phase 1 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by Incyte Corporation. The registered enrollment target is 53 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05222555, a Phase 1 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by Incyte Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG Tafasitamab
Study Locations (20)
Other
- Universitatsklinikum Salzburg - Salzburg
- Fakultni nemocnice Brno - Brno
- Fakultni nemocnice Ostrava - Ostrava
- Fakultni nemocnice Kralovske Vinohrady - Prague
- Vseobecna Fakultni Nemocnice V Praze - Prague
- Fakultni nemocnice v Motole - Prague
- Shamir Medical Center Assaf Harofeh - Be’er Ya‘aqov
- Lady Davis Carmel Medical Center - Haifa
- Hadassah Medical Center - Hadassah Ein Kerem - Jerusalem
- ZIV Medical Center - Safed
New Jersey
- Morristown Memorial Hospital - Morristown
Texas
- Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR - Dallas
Washington
- Vista Oncology - Olympia
Lower Austria
- UK St. Pölten - Sankt Pölten
Upper Austria
- Klinikum Wels Grieskirchen - Wels
Isère
- Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon - Grenoble
Loire-Atlantique
- CHU Nantes - Nantes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2022-07-19 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
What the registry record for NCT05222555 still lists
NCT05222555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT05222555 names 20 study sites across 11 states, led by Other, New Jersey, Texas.
Frequently Asked Questions
What is clinical trial NCT05222555 about?
NCT05222555 is a clinical study titled "Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients". This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior...
What is the current status of trial NCT05222555?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2022-07-19. Estimated completion is 2027-11-30.
What conditions does trial NCT05222555 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT05222555?
The interventions under investigation include: Lenalidomide (DRUG), Tafasitamab (DRUG).
Who is sponsoring clinical trial NCT05222555?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05222555 being conducted?
This trial has 20 study locations across New Jersey, Texas, Washington, Lower Austria, Upper Austria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05222555's enrollment target sits among peer trials
53 57th of 114 higher than 58 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma 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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