Study on the Safety and Effects of a New Dosing Schedule for Tafasitamab with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Incyte Corporation
ClinicalTrials ID:NCT05222555
This clinical trial is testing a new way of giving the drug Tafasitamab, combined with Lenalidomide, to see if it is safe and how it behaves in the body for patients with Diffuse Large B-Cell Lymphoma that has returned or not responded to treatment.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and how the body processes a new dosing schedule of the drug Tafasitamab when combined with Lenalidomide in patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has either come back or not responded to previous treatments. Participants should have had at least one, but no more than three, previous treatments and should not be eligible for high-dose chemotherapy with stem-cell transplantation.
Eligibility Criteria
Inclusion Criteria
- Able to provide signed consent to participate.
- Age 18 years or older.
- Confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
- Must provide a tumor sample for review.
- Have relapsed or refractory disease with at least one measurable tumor site.
- Have received 1 to 3 previous treatments, including one with a CD20-targeted therapy.
- Not eligible for intensive salvage therapy or stem-cell transplantation.
- Meet specific blood and organ function criteria.
- If previously treated with CD19-targeted therapy, must confirm CD19 positive lymphoma on a recent biopsy.
- Primary refractory disease with 1 to 3 previous treatments, including a CD20-targeted therapy.
Exclusion Criteria
- Currently in another clinical study or legally institutionalized.
- Have a different type of lymphoma or specific genetic markers.
- Have not stopped certain treatments or undergone major surgery recently.
- Have not recovered from previous treatment side effects.
- Previously treated with certain drugs or have allergies to study drugs.
- Recent stem cell transplantation or history of certain blood clots.
- History of other cancers that could interfere with the study.
- Positive for hepatitis B or C, or HIV.
- Have CNS lymphoma or significant health issues.
- Have certain genetic or digestive issues.
- Severe liver problems or allergies to study drugs.
- Any other condition that makes participation unsuitable.
- Women must agree to use birth control and not breastfeed or donate eggs. Men must agree to use condoms and not donate sperm.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Morristown Memorial Hospital | 07960-6459 | Morristown | New Jersey |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR | 75246-2092 | Dallas | Texas |
| Vista Oncology | 98506 | Olympia | Washington |
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