HOVON 133 (TRIANGLE) (FL)
Autologous Transplantation after a Rituximab/Ibrutinib/Ara-c Containing Induction in Generalized Mantle Cell Lymphoma - a randomized European MCL Network trial (TRIANGLE)
|Arm A: standard of care
||Alternating 3 cycles R-CHOP / 3 cycles R-DHAP induction followed by ASCT. Rituximab maintenance may be added.
||Alternating 3 cycles R-CHOP + ibrutinib / 3 cycles R-DHAP induction followed by ASCT and 2 years ibrutinib maintenance. Rituximab maintenance may be added.
||Alternating 3 cycles of R-CHOP + ibrutinib / 3 cycles R-DHAP induction, followed by 2 years ibrutinib maintenance. Rituximab maintenance may be added.
- Histologically confirmed diagnosis of mantle cell lymphoma according to WHO classification
- Suitable for high-dose treatment including high-dose Ara-C
- Stage II-IV Ann Arbor
- Age ≥ 18 years and ≤ 65 years
- Previously untreated mantle cell lymphoma
- At least 1 measurable lesion
- ECOG score of 0-2
- Major surgery within 4 weeks prior to randomization
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy outlined in this trial protocol
- AZ Delta Roeselare
- Universitair Ziekenhuis Antwerpen
- UZ Brussel
- Centre Hospitalier de Jolimont
- University Hospital Leuven Gasthuisberg
- Ziekenhuis Netwerk Antwerpen (ZNA) - Stuivenberg