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Trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to standard therapy versus standard therapy in patients newly diagnosed with lymphoma
EU CTIS ID: 2022-500237-92-00
What this study is testing
To compare the efficacy of tafasitamab plus lenalidomide in addition to R-CHOP versus tafasitamab placebo, lenalidomide placebo and R-CHOP (henceforth referred to as R-CHOP in the context of the control arm).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent form (ICF).
- Patient must have the following local laboratory criteria at screening: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) b. Platelet count ≥ 75 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert’s Syndrome or documented liver involvement by lymphoma. Patients with Gilbert’s Syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 × ULN d. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 3 × ULN, or ≤ 5 × ULN in cases of documented liver involvement e. Serum creatinine clearance must be ≥ 30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976)
- In the opinion of investigator, the patient must: a. Be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events, e.g. aspirin 75 to 325 mg per os, orally (PO) daily (81 to 325 mg PO daily in the US) or low molecular weight heparin (e.g. enoxaparin 40 mg (4,000 IU) once daily by subcutaneous (SC) injection). This is due to increased risk of thrombosis in patients treated with lenalidomide without prophylaxis. Patients unable or unwilling to take any prophylaxis are not eligible b. Be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations c. Not have a history of noncompliance in relation to medical regimens nor be considered potentially unreliable and/or uncooperative d. Be able to understand the reason for complying with the special conditions of the pregnancy prevention and in writing acknowledge to adhere to them
- Due to the teratogenic potential of lenalidomide, females of childbearing potential (FCBP) must: a. Not be pregnant as confirmed by a negative serum pregnancy test at screening and a medically supervised urine pregnancy test prior to starting study therapy b. Refrain from breast feeding and donating oocytes during the course of study and for three (3) months after the last dose of study drug or according to local guidelines for R-CHOP, whichever is longer c. Agree to ongoing pregnancy testing during the course of the study and after study therapy has ended. Additionally, agree to pregnancy testing and counseling if a patient misses her period or if there is any abnormality in her menstrual bleeding. This applies even if the patient applies complete sexual abstinence d. Commit to continued abstinence from heterosexual intercourse if it is in accordance with her lifestyle (which must be reviewed on a monthly basis) or agree to use and be able to comply with the use of highly effective contraception without interruption at least four (4) weeks prior to start of study drugs, during the study treatment and for three (3) months after the last dose of study drug, or, for R-CHOP, according to the local guidelines, whichever is longer.
- Male participants must: a. Use an effective barrier method of contraception without interruption if the patient is sexually active with a FCBP. Male participants should refrain from donating sperm during the study participation and for three (3) months after the last dose of study drug, or according to the local guidelines for R-CHOP, whichever is longer
- Adult subjects aged 18 (or legal age per local regulations) to 80 years of age inclusive.
You likely can't join if
- 1) 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.
- 4g) Patients with 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
- 4h) Patients with history or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- 4i) Patients with vaccination with live vaccine within 21 days prior to study randomization
- 4j) Patients with major surgery within up to 21 days prior to signing the informed consent form (ICF), unless the patient is recovered at the time of signing the ICF
- 4k) Patients with any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
See the full eligibility criteria
Who can join
- Signed written informed consent form (ICF).
- Patient must have the following local laboratory criteria at screening: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) b. Platelet count ≥ 75 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert’s Syndrome or documented liver involvement by lymphoma. Patients with Gilbert’s Syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 × ULN d. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 3 × ULN, or ≤ 5 × ULN in cases of documented liver involvement e. Serum creatinine clearance must be ≥ 30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976)
- In the opinion of investigator, the patient must: a. Be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events, e.g. aspirin 75 to 325 mg per os, orally (PO) daily (81 to 325 mg PO daily in the US) or low molecular weight heparin (e.g. enoxaparin 40 mg (4,000 IU) once daily by subcutaneous (SC) injection). This is due to increased risk of thrombosis in patients treated with lenalidomide without prophylaxis. Patients unable or unwilling to take any prophylaxis are not eligible b. Be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations c. Not have a history of noncompliance in relation to medical regimens nor be considered potentially unreliable and/or uncooperative d. Be able to understand the reason for complying with the special conditions of the pregnancy prevention and in writing acknowledge to adhere to them
- Due to the teratogenic potential of lenalidomide, females of childbearing potential (FCBP) must: a. Not be pregnant as confirmed by a negative serum pregnancy test at screening and a medically supervised urine pregnancy test prior to starting study therapy b. Refrain from breast feeding and donating oocytes during the course of study and for three (3) months after the last dose of study drug or according to local guidelines for R-CHOP, whichever is longer c. Agree to ongoing pregnancy testing during the course of the study and after study therapy has ended. Additionally, agree to pregnancy testing and counseling if a patient misses her period or if there is any abnormality in her menstrual bleeding. This applies even if the patient applies complete sexual abstinence d. Commit to continued abstinence from heterosexual intercourse if it is in accordance with her lifestyle (which must be reviewed on a monthly basis) or agree to use and be able to comply with the use of highly effective contraception without interruption at least four (4) weeks prior to start of study drugs, during the study treatment and for three (3) months after the last dose of study drug, or, for R-CHOP, according to the local guidelines, whichever is longer.
- Male participants must: a. Use an effective barrier method of contraception without interruption if the patient is sexually active with a FCBP. Male participants should refrain from donating sperm during the study participation and for three (3) months after the last dose of study drug, or according to the local guidelines for R-CHOP, whichever is longer
- Adult subjects aged 18 (or legal age per local regulations) to 80 years of age inclusive.
- 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: • DLBCL, NOS including GCB type, ABC type • T-cell rich large BCL • Epstein-Barr virus-positive DLBCL, NOS • Anaplastic lymphoma kinase (ALK)-positive large BCL • Human herpes virus-8 (HHV8)-positive DLBCL, NOS • 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 • HGBL-NOS • DLBCL coexistent with either FL of any grade, gastric mucosa-associated lymphoid tissue (MALT) lymphoma or non-gastric MALT lymphoma • FL Grade 3b
- Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review. Please note: Neither receipt of tumor samples nor central review of diagnosis is necessary prior to study enrollment.
- Up to six (6) of the largest target nodes, nodal masses, or other lymphomatous lesions that are measurable in two (2) diameters should be identified by local assessment from different body regions representative of the patient’s overall disease burden and include mediastinal and retroperitoneal disease, if involved. At baseline, a measurable node must be greater than 15 mm in longest diameter (LDi). Measurable extranodal disease may be included in the six (6) representative, measured lesions. At baseline, measurable extranodal lesions should be greater than 10 mm LDi. All other lesions (including nodal, extranodal, and assessable disease) should be followed as nonmeasured disease as non-target lesions (e.g. cutaneous, GI, spleen, liver, kidneys, pleural or pericardial effusions, ascites, bone, bone marrow). Patients with ONLY bone lesions should be excluded. At least one (1) measurable lesion must be confirmed to be PET-positive (Deauville score of 4 or 5) at the time of randomization by local assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- 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 (cycle 1 study day 1 (C1D1)) ≤ 28 days.
- Left ventricular ejection fraction ≥ 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan.
What rules you out
- 1) 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.
- 4g) Patients with 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
- 4h) Patients with history or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- 4i) Patients with vaccination with live vaccine within 21 days prior to study randomization
- 4j) Patients with major surgery within up to 21 days prior to signing the informed consent form (ICF), unless the patient is recovered at the time of signing the ICF
- 4k) Patients with any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
- 4l) Patients with contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
- 4m) Patients with pregnancy or lactation
- 4n) Patients with history of hypersensitivity to any component of R-CHOP, to lenalidomide, to compounds of similar biological or chemical composition to tafasitamab, IMiDs and/or the excipients contained in the study drug formulations
- 2) History of radiation therapy to ≥ 25% of the bone marrow for other diseases.
- 3) History of prior non-hematologic malignancy except for the following: a. Malignancy treated with curative intent and with no evidence of active disease present for more than two (2) years before screening b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer. c. Adequately treated carcinoma in situ without current evidence of disease.
- 4a) Patients with positive local test result during screening for hepatitis C (hepatitis C virus [HCV] antibody serology testing) and a positive test for HCV RNA. Patients with positive serology must have been tested locally for HCV RNA and are eligible, in case of negative HCV RNA test results
- 4b) Patients with positive local test result during screening for chronic hepatitis B virus (HBV) infection (defined by hepatitis B surface antigen [HBsAg] positivity). Patients with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody [HBcAb]) may be included if HBV DNA was undetectable (local test result), provided that they are willing to undergo ongoing DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible
- 4c) Patients with Seropositive (local test during screening) for, or history of active viral infection with human immunodeficiency virus (HIV)
- 4d) Patients with 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). Antiviral or antibacterial prophylaxis may be administered as per institutional guidelines
- 4e) Patients with positive results for the human T-lymphotropic 1 virus (HTLV-1). HTLV testing during screening is required for patients at sites in endemic countries (Japan and Melanesia and countries in the Caribbean basin, South America, Central America, and sub-Saharan Africa)
- 4f) Patients with known CNS lymphoma involvement
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Ukraine
- New Zealand
- Turkey
- Canada
- Argentina
- Israel
- United States
- Taiwan
- Hong Kong
- Thailand
- Serbia
- United Kingdom
- Malaysia
- Australia
- Russian Federation
- Korea, Republic of
- Philippines
- Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Ukraine; New Zealand; Turkey; Canada; Argentina and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.