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ACTIVE NOT RECRUITING Phase 1

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

NCT05222555 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 53 participants
Start Date 2022-07-19
Est. Completion 2027-11-30
Phase Phase 1

Sponsor

Incyte Corporation

163 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05222555

The ClinicalTrials.gov registry entry for NCT05222555 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05222555 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, New Jersey, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05222555?

The interventions under investigation include: Lenalidomide (DRUG), Tafasitamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05222555?

This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial