Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Phase 1

• Conditions: Relapsed Non Hodgkin Lymphoma
• Interventions: Drug: Venetoclax

• Registration Number: NCT03505944
• Lead Sponsor: Nordic Lymphoma Group

Brief Summary

Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of rituximab-lenalidomide in patients with relapsed/refractory MCL.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-04-23
• Study Start: 2018-07-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-13
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Venetoclax	Venetoclax+lenalidomide+rituximab

Primary Outcome Measures

Name	Time	Method
Overall response rate	6 months	The primary objective is to assess the overall response rate (ORR) at 6 months with lenalidomide-venetoclax and rituximab, in patients with relapsed or refractory mantle cell lymphoma, by use of an MRD driven strategy. ORR includes complete (CR) and partial remissions (PR).

Trial Locations

Locations (17)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Oslo University Hospital; 🇳🇴 Oslo, Norway

Uppsla Academic Hospital; 🇸🇪 Uppsala, Sweden

Clinic of Hematology L-4241 Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Department of Hematology Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Hematology X Odense University Hospital; 🇩🇰 Odense, Denmark

Hæmatologisk Afdeling Zeeland University Hospital, Roskilde; 🇩🇰 Roskilde, Denmark

Department of Hematology Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Tampere University Hospital; 🇫🇮 Tampere, Finland

Department of Hematology Helsinki University Hospital Comprehensive Cancer Center; 🇫🇮 Helsinki, Finland

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

St. Olav Hospital; 🇳🇴 Trondheim, Norway

Department of Hematology Linköping University Hospital; 🇸🇪 Linköping, Sweden

Department of Medicine Sunderbyn Hospital; 🇸🇪 Luleå, Sweden

Skane University Hospital; 🇸🇪 Lund, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Department of Oncology Norrland University Hospital; 🇸🇪 Umeå, Sweden