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ACTIVE NOT RECRUITING

NCT04824092

PHASE3

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

899

Start Date

2021-05-11

Completion Date

2027-11-01

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Diffuse Large B-cell Lymphoma

Interventions

DRUG

Tafasitamab

Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Tafasitamab placebo

0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide placebo

Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.

Major Inclusion Criteria: * Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible: 1. DLBCL, NOS including GCB type, ABC type 2. T-cell rich large BCL 3. Epstein-Barr virus-positive DLBCL, NOS 4. Anaplastic lymphoma kinase (ALK)-positive large BCL 5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS 6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab \[DA-EPOCH-R\] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine \[Hyper CVAD\]), this patient would not be considered eligible for this study 7. HGBL-NOS 8. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma 9. FL grade 3b * Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review * IPI status of 3 to 5 (for patients \> 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age) * Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing B Cell lymphoma according to the local pathology report) and the start of treatment (C1D1) ≤ 28 days * ECOG performance status of 0, 1, or 2 * Left ventricular ejection fraction equal to or greater 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan * Adequate hematologic function * Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended * Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm Major Exclusion Criteria: * Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma * History of prior non-hematologic malignancy except for the following: 1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening 2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer 3. Adequately treated carcinoma in situ without current evidence of disease * Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment * Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines * Known CNS lymphoma involvement * Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay) * History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent

Locations (307)

MorphoSys Research Site

Daphne, Alabama, United States

MorphoSys Research Site

Anaheim, California, United States

MorphoSys Research Site

Clovis, California, United States

MorphoSys Research Site

Fullerton, California, United States

MorphoSys Research Site

Harbor City, California, United States

MorphoSys Research Site

Los Angeles, California, United States

MorphoSys Research Site

San Diego, California, United States

MorphoSys Research Site

Whittier, California, United States

MorphoSys Research Site

Aurora, Colorado, United States

MorphoSys Research Site

Jacksonville, Florida, United States

MorphoSys Research Site

Honolulu, Hawaii, United States

MorphoSys Research Site

Wichita, Kansas, United States

MorphoSys Research Site

Lexington, Kentucky, United States

MorphoSys Research Site

Louisville, Kentucky, United States

MorphoSys Research Site

Baltimore, Maryland, United States

MorphoSys Research Site

Bethesda, Maryland, United States

MorphoSys Research Site

Columbia, Maryland, United States

MorphoSys Research Site

Detroit, Michigan, United States

MorphoSys Research Site

Minneapolis, Minnesota, United States

MorphoSys Research Site

Rochester, Minnesota, United States

MorphoSys Research Site

Kansas City, Missouri, United States

MorphoSys Research Site

Lebanon, New Hampshire, United States

MorphoSys Research Site

Florham Park, New Jersey, United States

MorphoSys Research Site

Buffalo, New York, United States

MorphoSys Research Site

Rochester, New York, United States

MorphoSys Research Site

Canton, Ohio, United States

MorphoSys Research Site

Cincinnati, Ohio, United States

MorphoSys Research Site

Eugene, Oregon, United States

MorphoSys Research Site

Danville, Pennsylvania, United States

MorphoSys Research Site

Chattanooga, Tennessee, United States

MorphoSys Research Site

Germantown, Tennessee, United States

MorphoSys Research Site

Nashville, Tennessee, United States

MorphoSys Research Site

Austin, Texas, United States

MorphoSys Research Site

Bedford, Texas, United States

MorphoSys Research Site

Denison, Texas, United States

MorphoSys Research Site

Fort Worth, Texas, United States

MorphoSys Research Site

Houston, Texas, United States

MorphoSys Research Site

McAllen, Texas, United States

MorphoSys Research Site

Tyler, Texas, United States

MorphoSys Research Site

Ogden, Utah, United States

MorphoSys Research Site

Salt Lake City, Utah, United States

MorphoSys Research Site

Gainesville, Virginia, United States

MorphoSys Research Site

Roanoke, Virginia, United States

MorphoSys Research Site

Virginia Beach, Virginia, United States

MorphoSys Research Site

Olympia, Washington, United States

MorphoSys Research Site

Tacoma, Washington, United States

MorphoSys Research Site

Marshfield, Wisconsin, United States

MorphoSys Research Site

Buenos Aires, Argentina

MorphoSys Research Site

Buenos Aires, Argentina

MorphoSys Research Site

Cipolletti, Argentina

MorphoSys Research Site

Rosario, Argentina

MorphoSys Research Site

San Miguel de Tucumán, Argentina

MorphoSys Research Site

Adelaide, Australia

MorphoSys Research Site

Ballarat, Australia

MorphoSys Research Site

Birtinya, Australia

MorphoSys Research Site

Brisbane, Australia

MorphoSys Research Site

Canberra, Australia

MorphoSys Research Site

Clayton, Australia

MorphoSys Research Site

Frankston, Australia

MorphoSys Research Site

Geelong, Australia

MorphoSys Research Site

Gold Coast, Australia

MorphoSys Research Site

Gosford, Australia

MorphoSys Research Site

Greenslopes, Australia

MorphoSys Research Site

Hobart, Australia

MorphoSys Research Site

Kingswood, Australia

MorphoSys Research Site

Kogarah, Australia

MorphoSys Research Site

Launceston, Australia

MorphoSys Research Site

Malvern, Australia

MorphoSys Research Site

Melbourne, Australia

MorphoSys Research Site

Melbourne, Australia

MorphoSys Research Site

Nedlands, Australia

MorphoSys Research Site

Perth, Australia

MorphoSys Research Site

Perth, Australia

MorphoSys Research Site

Richmond, Australia

MorphoSys Research Site

St Albans, Australia

MorphoSys Research Site

Sydney, Australia

MorphoSys Research Site

Sydney, Australia

MorphoSys Research Site

Townsville, Australia

MorphoSys Research Site

Wahroonga, Australia

MorphoSys Research Site

Waratah, Australia

MorphoSys Research Site

Wollongong, Australia

MorphoSys Research Site

Innsbruck, Austria

MorphoSys Research Site

Linz, Austria

MorphoSys Research Site

Linz, Austria

MorphoSys Research Site

Rankweil, Austria

MorphoSys Research Site

Sankt Pölten, Austria

MorphoSys Research Site

Vienna, Austria

MorphoSys Research Site

Vienna, Austria

MorphoSys Research Site

Halifax, Canada

MorphoSys Research Site

London, Canada

MorphoSys Research Site

Montreal, Canada

MorphoSys Research Site

Saskatoon, Canada

MorphoSys Research Site

Sherbrooke, Canada

MorphoSys Research Site

Medellín, Colombia

MorphoSys Research Site

Valledupar, Colombia

MorphoSys Research Site

Brno, Czechia

MorphoSys Research Site

Hradec Králové, Czechia

MorphoSys Research Site

Olomouc, Czechia

MorphoSys Research Site

Ostrava, Czechia

MorphoSys Research Site

Prague, Czechia

And 207 more locations on ClinicalTrials.gov

Clinical Research Directory

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (307)