drugset / Trial / NCT00499018
Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma
Phase 3
Unknown
399 enrolled
Fondazione Italiana Linfomi - ETS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to define an improvement in patients randomized in four different arms: Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.
Timeline
- Start
- 2006-01
- Primary completion
- 2011-06
- Completion
- 2013-09
Outcome
Met primary endpoint
paper 2-year failure-free survival was 71% (95% CI 64-77) in the transplantation group versus 62% (95% CI 55-68) in the no transplantation group (hazard ratio [HR] 0·65 [95% CI 0·47-0·91]; stratified log-rank test p=0·012). PMID 28668386 ↗
Publications
- Derenzini E, Mazzara S, Melle F, Motta G, Fabbri M, Bruna R, Agostinelli C, Cesano A, Corsini CA, Chen N, Righi S, Sabattini E, Chiappella A, Calleri A, Fiori S, Tabanelli V, Cabras A, Pruneri G, Vitolo U, Gianni AM, Rambaldi A, Corradini P, Zinzani PL, Tarella C, Pileri S. A three-gene signature based on MYC, BCL-2 and NFKBIA improves risk stratification in diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2405-2416. doi: 10.3324/haematol.2019.236455.
- Chiappella A, Martelli M, Angelucci E, Brusamolino E, Evangelista A, Carella AM, Stelitano C, Rossi G, Balzarotti M, Merli F, Gaidano G, Pavone V, Rigacci L, Zaja F, D'Arco A, Cascavilla N, Russo E, Castellino A, Gotti M, Congiu AG, Cabras MG, Tucci A, Agostinelli C, Ciccone G, Pileri SA, Vitolo U. Rituximab-dose-dense chemotherapy with or without high-dose chemotherapy plus autologous stem-cell transplantation in high-risk diffuse large B-cell lymphoma (DLCL04): final results of a multicentre, open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2017 Aug;18(8):1076-1088. doi: 10.1016/S1470-2045(17)30444-8. Epub 2017 Jun 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 1200 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 70 mg/m2 | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 8 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | — |
| Subject | carmustine | Small molecule | 300 mg/m2 | Intravenous |
| Background | Lenograstim | Protein / enzyme biologic | 5 ug/kg | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |