A clinical study of the investigational drug Tafasitamab in combination with Lenalidomide and Rituximab compared to treatment with a placebo (a substance without active ingredient) in combination with Lenalidomide and Rituximab in patients with follicular lymphoma (FL) or marginal zone lymphoma (MZL), which has returned (relapsed) or has not responded to previous treatment (refractory).
Descrizione riassuntiva dello studio
This study aims to investigate how safe the investigational drug Tafasitamab in combination with Rituximab and Lenalidomide is, and how patients with follicular lymphoma (FL) or marginal zone lymphoma (MZL), which has returned (relapsed) or has not responded to treatment (is refractory), respond compared to placebo plus Rituximab and Lenalidomide. A placebo is a preparation made in a form usual for drugs, but contains no medicinal active ingredients. The investigational drug Tafasitamab or placebo and Rituximab are administered as an infusion, and Lenalidomide in tablet form. The administration occurs at various times in 28-day cycles. The probability that you will receive the investigational drug together with Rituximab and Lenalidomide is 50% (1 in 2). The probability that you will receive placebo together with Rituximab and Lenalidomide is also 50% (1 in 2). Tafasitamab (MOR00208) is an investigational drug. "Investigational drug" means that Tafasitamab is not yet approved as a medication for the treatment of patients with FL or MZL. The combination of Rituximab and Lenalidomide has been approved in the USA for the treatment of adult patients with pre-treated FL or MZL and in the European Union (EU) and Switzerland for the treatment of adult patients with pre-treated FL. This study is double-blind, meaning that neither the participant nor the investigator will know during the study whether the participant receives the investigational drug or placebo (in addition to Rituximab and Lenalidomide). This study is also randomized, meaning that the participant will be assigned randomly (like flipping a coin) to receive either the investigational drug or the placebo. Participants will receive the investigational combination for 1 year (in 28-day cycles), after which they will be monitored for 5 years.
(BASEC)
Intervento studiato
Assessment of the efficacy of Tafasitamab in combination with Lenalidomide and Rituximab based on the time to disease progression, the rate of patients who have fully responded to treatment at treatment end (determined by positron emission tomography (PET) scans), and the survival rate in the patient group with FL.
(BASEC)
Malattie studiate
returned/not previously responding follicular lymphoma (FL) of grade 1 to 3a or marginal zone lymphoma (MZL), which has recurred (relapsed) or has not responded to previous treatment (refractory).
(BASEC)
Main inclusion criteria Male and female participants aged at least 18 years who have FL grade 1, 2, or 3a or lymph node MZL, splenic MZL or a marginal zone lymphoma (MALT lymphoma) localized outside of lymph nodes, confirmed by a tissue examination. • The participant must have previously been treated with at least one antibody immunotherapy or with a combination of chemotherapy and immunotherapy. • Documented return, no response, or progression of disease after treatment with a prior therapy • the willingness to avoid pregnancy or conception of children (BASEC)
Criteri di esclusione
Main exclusion criteria Women who are pregnant or breastfeeding. Any other form of lymphoma than FL and MZL or evidence of lymphoma that in the opinion of the study physician has progressed to a more aggressive grade. History of radiation therapy to 25% or more of the bone marrow due to other conditions. Other cancers in the history (with certain exceptions) Heart failure (reduction of heart pump function by at least 50%) Current infection (including SARS-CoV-2), hepatitis B and/or C virus infection, HIV infection. Patients in a severely immunocompromised state. Known lymphoma involvement of the central nervous system. (BASEC)
Luogo dello studio
Basilea, Bellinzona, Berna, San Gallo, Winterthur, Zurigo, Altro
(BASEC)
Thun
(BASEC)
Sponsor
Incyte Biosciences International Sàrl
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Incyte Corporation, Clinical Trial Information
+1 302 498 6700
RA@clutterincyte.comSponsor
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
06.12.2021
(BASEC)
ID di studio ICTRP
EUCTR2020-004407-13 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma (BASEC)
Titolo accademico
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma (ICTRP)
Titolo pubblico
A Phase 3 study of Tafasitamab plus Lenalidomide in addition to Rituximab, versus Lenalidomide plus Rituximab in patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma (ICTRP)
Malattie studiate
follicular lymphoma (FL) and marginal zone lymphoma (MZL)
MedDRA version: 20.1Level: LLTClassification code 10080213Term: In situ follicular lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04] (ICTRP)
Intervento studiato
Product Name: Tafasitamab
Product Code: MOR208
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TAFASITAMAB
Current Sponsor code: MOR208
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Revlimid 20 mg hard capsule
Product Name: lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: Zelvina 20 mg hard capsule
Product Name: Lenalidomide ADALVO
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: Zelvina 15 mg hard capsule
Product Name: Lenalidomide ADALVO
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: Zelvina 10 mg hard capsule
Product Name: Lenalidomide ADALVO
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Revlimid 15 mg hard capsule
Product Name: lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: Revlimid 10 mg hard capsule
Product Name: lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 19173 (ICTRP)
Tipo di studio
Interventional clinical trial of medicinal product (ICTRP)
Disegno dello studio
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2 (ICTRP)
Criteri di inclusione/esclusione
Gender:
Female: yes
Male: yes
Inclusion criteria:
* Male and female participants at least 18 years of age who have a histologically confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL of the MALT.
* Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance.
* Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy:
- Relapsed lymphoma: relapsed after initial response of complete response (CR) to prior therapy.
- Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or partial response (PR) that lasted less than 6 months before lymphoma progression.
- Progressive lymphoma: PD after initial response of PR or stable disease (SD) to prior therapy.
* Willingness to avoid pregnancy or fathering children
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 352
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 266
(ICTRP)
Exclusion criteria:
* Women who are pregnant or breastfeeding.
* Any histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment.
* History of radiation therapy to = 25% of the BM for other diseases.
* Active systemic infection.
* Participants in a severely immunocompromised state.
* Known CNS lymphoma involvement.
Endpoint primari e secondari
Main Objective: To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab to the efficacy of placebo and lenalidomide in addition to rituximab in participants with relapsed/ refractor (R/R) FL.;Secondary Objective: * To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab versus placebo and lenalidomide in addition to rituximab in the overall population (FL and MZL)
* To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab versus
placebo and lenalidomide in addition to rituximab in the FL population.;Primary end point(s): PFS by investigator (INV) assessment in the FL population, using Lugano 2014 criteria (Cheson et al 2014).
PFS is defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.;Timepoint(s) of evaluation of this end point: The primary analysis will be performed after approximately 174 PFS events based on INV are
observed in the FL population in the full analysis set (ICTRP)
Secondary end point(s): * PFS by INV assessment in the overall population (FL and MZL populations).
* PET-CR rate at EOT (90 days after last treatment) by INV in the FL population.
*OS in the FL population.;Timepoint(s) of evaluation of this end point: EOT (90 days after last treatment) (ICTRP)
Data di registrazione
23.04.2021 (ICTRP)
Inclusione del primo partecipante
24.06.2021 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Clinical Trial Information, RA@incyte.com, +1 302 498 6700, Incyte Corporation (ICTRP)
ID secondari
INCMOR0208-301, 2020-004407-13-BE (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004407-13 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile