Brentuximab Vedotin plus Lenalidomide and Rituximab for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Descrizione riassuntiva dello studio
The purpose of this study is to compare the (positive or negative) effects of Brentuximab vedotin in combination with Lenalidomide (L) and Rituximab (R), compared to placebo (P) in combination with Lenalidomide and Rituximab for the treatment of DLBCL. There are two treatment groups in this study: One group receives Lenalidomide and Rituximab with Brentuximab vedotin (BV/L-R) The other group receives Lenalidomide and Rituximab with placebo (P/R-L). A placebo contains no active ingredient. The first six patients in this study will receive Lenalidomide and Rituximab with Brentuximab vedotin (BV/L-R). After that, assignment to the two treatments will be done randomly, i.e., like a lottery. This is a blinded study, the assignment to the two groups will only be disclosed at the end of the study for study participants, the principal investigator, and the study team. All individuals with diffuse large B-cell lymphoma who have relapsed (relapsed) or have not improved (refractory) despite treatment can participate.
(BASEC)
Intervento studiato
This study consists of a so-called screening phase, a treatment phase, and a follow-up phase after treatment completion.
If the screening assessments show that you can participate in the study, you will be randomly assigned to one of the two following treatment groups:
1) BV/R-L or 2) P/R-L.
The assignment to the two treatments will be done randomly, i.e., like a lottery;
Each of the two treatment arms consists of a treatment cycle every 3 weeks until disease stabilization is achieved.
You will spend the first day of each cycle in the hospital, where the study drug and Rituximab will be administered through an arm vein;
Lenalidomide will be given orally and the remaining doses for this cycle will be handed out for home intake.
If no reaction is achieved during the first cycle, Rituximab will be administered subcutaneously starting from the second cycle.
At each study visit, approximately 45-60 ml (3 to 4 tablespoons) of blood will be drawn. On day 15 of the first cycle and thereafter every 6 weeks, a computed tomography (CT) and a PET scan will be performed.
Treatment will continue until disease stabilization without progression or toxicity is achieved.
About 30 days after the start of the last cycle, you will be asked to attend a post-treatment follow-up appointment. This appointment will include a physical examination, a blood test, imaging, and a pregnancy test if indicated. Thereafter, quarterly telephone interviews will be conducted in the first year and then semi-annually to assess your health status and disease progression.
(BASEC)
Malattie studiate
This study is being conducted to determine whether the addition of Brentuximab Vedotin helps two medications better treat patients with diffuse large B-cell lymphoma (DLBCL). The participants in this study have DLBCL that has returned despite treatment or has not improved.
(BASEC)
- Histologically confirmed B-cell non-Hodgkin lymphoma. - Men and women aged at least 18 years. - Patients who have not adequately responded to at least two prior systemic therapies or have experienced a relapse. (BASEC)
Criteri di esclusione
- History of another malignant disease within the last two years or residual signs of a prior malignant disease. - History of progressive multifocal leukoencephalopathy (PML). - Pregnant and/or breastfeeding women cannot participate in this study. (BASEC)
Luogo dello studio
Basilea, Winterthur, Zurigo
(BASEC)
Sponsor
Pfizer AG, Alessandra Fedato Schärenmoosstrasse 99, 8052 Zürich, Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Alessandra Fedato
+41 763885296
alessandra.fedato@clutterpfizer.comPfizer AG, Alessandra Fedato Schärenmoosstrasse 99, 8052 Zürich, Switzerland
(BASEC)
Informazioni generali
Pfizer
(ICTRP)
Informazioni scientifiche
Seagen Inc.
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
05.03.2021
(BASEC)
ID di studio ICTRP
NCT04404283 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (BASEC)
Titolo accademico
A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (ICTRP)
Titolo pubblico
Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL (ICTRP)
Malattie studiate
Diffuse Large B-cell Lymphoma (ICTRP)
Intervento studiato
Drug: Brentuximab vedotinDrug: RituximabDrug: LenalidomideOther: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Participants with relapsed or refractory diffuse and transformed large B-cell
lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be
histologically determined by local pathology assessment for the purposes of study
eligibility and stratification.
- Participants must have R/R disease following 2 or more lines of prior systemic
therapy.
- For participants with transformed DLBCL, at least the last systemic therapy
used must have been for DLBCL
- Participants must be HSCT or CAR-T ineligible according to the investigator and must
meet at least one of the following criteria:
1. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic
dysfunction that in the opinion of the Investigator make the participant
medically unfit to received HSCT or CAR-T therapy
2. Active disease following induction and salvage chemotherapy
3. Inadequate stem cell mobilization (for HSCT)
4. Relapse following prior HSCT or CAR-T
5. Unable to receive CAR-T therapy due to financial, geographic, insurance, or
manufacturing issues
- Participants must have tumor tissue submitted to the central pathology lab. The
tumor tissue submitted should be from the most recent biopsy that contains DLBCL.
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission
tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed
tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
Exclusion Criteria:
- History of another malignancy within 2 years before the first dose of study drug or
any evidence of residual disease from a previously diagnosed malignancy
- History of progressive multifocal leukoencephalopathy (PML)
- Active cerebral/meningeal disease related to the underlying malignancy. Participants
with a history of cerebral/meningeal disease related to the underlying malignancy
are allowed if prior CNS disease has been effectively treated and without
progression for at least 3 months.
- Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or
fungal infection within 2 weeks prior to the first dose of study drug. Routine
antimicrobial prophylaxis is permitted
- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with
immunotherapy that is not completed 3 weeks prior to first dose of study drug,
unless underlying disease has progressed on treatment
- Previous treatment with brentuximab vedotin or lenalidomide.
- Previous treatment with other vedotin-based ADCs is permitted if the last dose
is at least 6 months prior to Day 1.
- Current therapy with immunosuppressive medications (including steroids), other
systemic anti-neoplastic, or investigational agents
a) Prednisone (or equivalent) =10 mg/day may be used for non-lymphomatous purposes
- Documented history of a cerebral vascular event (stroke or transient ischemic
attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with
New York Heart Association (NYHA) Class III-IV within 6 months prior to the first
dose of study drugs
- Congestive heart failure, Class III or IV, by the NYHA criteria
- Grade 2 or higher peripheral sensory or motor neuropathy at baseline (ICTRP)
non disponibile
Endpoint primari e secondari
Overall survival (OS) (ICTRP)
Progression-free survival (PFS);Objective response rate (ORR);Complete response (CR) rate;Duration of response (DOR);Incidence of adverse events;OS in CD30+ participants (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Pfizer CT.gov Call Center, Pfizer (ICTRP)
ID secondari
C5691003, 2023-503384-41-00, SGN35-031 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT04404283 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile