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Trial Details
Trial status:
Archived
Recruitment start date:
01/11/2018
Funder:
Klinikum der Universität München, Germany
Sponsor:
Klinikum der Universität München, Germany
Chief Investigator:
Simon Rule
Recruitment target:
100
EudraCT number:
2014-001363-12
Contact details:
ctc.triangle@ucl.ac.uk
Lay summary:
Triangle
Autologous transplantation after a rituximab/ ibrutinib/ Ara-C containing induction in generalized mantle cell lymphoma – a randomized European MCL network trial.
Description
Design: Triangle is a randomized, three-arm, parallel-group, open label international phase III trial. 
Treatment:
This study is for patients who have advanced-stage Mantle Cell Lymphoma (MCL). Treatment for MCL with chemotherapy often results in a reduction in tumour size, but many patients experience a relapse later (recurrence of the disease). Because of this, current treatment usually involves two stages. The initial treatment (induction treatment) aims to shrink the tumour as much as possible. This is followed by a second phase of treatment (consolidation treatment) to consolidate this reduction in tumour size.  

There are several different treatment options for MCL. The best option for a patient depends on their age, fitness and whether their doctor thinks they are a good candidate for a stem cell transplant. 

The aim of this study is to improve the treatment outcome for patients with MCL. In this study, three different treatment options are being compared. Patients will be randomly assigned to one of the three treatment arms; treatment Arm A, Arm A+I or Arm I. Arms A+I and I include the IMP Ibrutinib, which might improve outcomes in MCL patients. 

Patients randomised to Arm A will receive the standard treatment for MCL, which is what they would be likely to receive if they were not in the trial.  This involves 3 cycles of R-CHOP chemotherapy alternating with 3 cycles of R-DHAP chemotherapy, followed by an autologous stem cell transplant (ASCT). Patients randomised to arm A+I will receive the same treatment, but Ibrutinib will be given alongside the R-CHOP chemotherapy. These patients will also receive 2 years of ibrutinib maintenance treatment after the ASCT. Patients randomised to Arm I will also receive R-CHOP+I alternating with R-DHAP, but will not be given ASCT and will instead proceed directly to ibrutinib maintenance. All patients will be followed-up for a period of time after completing treatment. 

Key inclusion/exclusion criteria: Patients must have a histologically confirmed diagnosis of MCL and be suitable for high-dose treatment including high-dose Ara-C. Patients are excluded if they have had any prior treatment for their MCL, if they have undergone major surgery within 4 weeks of randomization, or if they require treatment with anticoagulants or CYP3A4/5 inhibitors. 
Duration of recruitment: 5 years
Aim
According to current European guidelines the current standard of care in younger patients with MCL is a dose-intensified approach with a cytarabine-containing immunochemotherapy induction followed by ASCT. Ibrutinib has recently shown impressive efficacy and favourable tolerability data in relapsed MCL. Therefore, this study aims to investigate in an international, multi-centre setting whether the addition of ibrutinib to current standard treatment could improve outcomes. Additionally, this study will investigate whether ASCT still leads to favourable outcomes when compared to standard immunochemotherapy plus ibrutinib. Currently, there is only data to support the combination of ibrutinib and R-CHOP chemotherapy.

The overall aim of this study is to establish one of the three study arms as future standard of care based on investigator-assessed failure-free survival. This study also aims to determine the safety and tolerability of ibrutinib during induction and maintenance therapy.  
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
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