JRCT ID: jRCT2071220021
Registered date:24/06/2022
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)
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Diffuse Large B-cell Lymphoma |
Date of first enrollment | 14/07/2022 |
Target sample size | 880 |
Countries of recruitment | U.S.A,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Canada,Japan,Colombia,Japan,Czechia,Japan,France,Japan,Germany,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Malaysia,Japan,New Zealand,Japan,Philippines,Japan,Poland,Japan,Romania,Japan,Russian Federation,Japan,Serbia,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,Ukraine,Japan,United Kingdom,Japan,Hong Kong,Japan |
Study type | Interventional |
Intervention(s) | 1. Experimental: Tafasitamab plus lenalidomide in addition to R-CHOP - Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles: - Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15. - Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle - R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle 2. Placebo Comparator: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP - Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles: - Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle - Lenalidomide placebo: Days 1-10 of each 21-day cycle - R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle |
Outcome(s)
Primary Outcome | PFS-INV |
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Secondary Outcome | 1. EFS-INV 2. Overall Survival(OS) 3. Metabolic PET-negative CR-rate at EOT by BIRC 4. Metabolic PET-negative CR-rate at EOT by INV 5. ORR as per INV at EOT 6. Time to next anti-lymphoma treatment (TTNT) 7. Duration of Complete Response (CR) as assessed by the investigator 8. EFS at 3 years 9. PFS at 3 years 10. OS at 3 years |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | 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 |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Ueda Eiji |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04824092 |
Contact
Public contact | |
Name | Medical Information Center |
Address | Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006 |
Telephone | +81-120-094-139 |
jpmedinfo@incyte.com | |
Affiliation | Incyte Biosciences Japan G.K. |
Scientific contact | |
Name | Eiji Ueda |
Address | Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006 |
Telephone | +81-120-094-139 |
jpmedinfo@incyte.com | |
Affiliation | Incyte Biosciences Japan G.K. |