NCT00355199

Multicentric Randomized Phase III Study Comparing High Doses of Chemotherapy With Rituximab Followed by Auto-transplant HPC Versus CHOP Plus Rituximab as First Line Therapy in High Risk Patients With DLBCL Non-Hodgkin's Lymphomas

Completed Phase 3 Results posted Last updated 8 August 2017

What this trial tests

Phase 3 trial testing Rituximab-HDS in Diffuse Large B-Cell Lymphoma in 246 participants. Completed in 1 March 2013.

Timeline

1 May 2005

Primary endpoint
1 March 2013

1 March 2013

Quick facts

Lead sponsor	Gruppo Italiano Terapie Innovative nei Linfomi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	246
Start date	1 May 2005
Primary completion	1 March 2013
Estimated completion	1 March 2013
Sites	16 locations across Italy

Drugs / interventions tested

• Rituximab-HDS — full drug profile →
• Rituximab-CHOP

Conditions studied

• Diffuse Large B-Cell Lymphoma — all drugs for Diffuse Large B-Cell Lymphoma →

Sponsor

Gruppo Italiano Terapie Innovative nei Linfomi — full company profile →

Who can join

Adults 18 to 65, any sex, with Diffuse Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Event Free Survival
  Time frame: 36 months from end of therapy
  EFS was defined from the time of the study entry to any treatment failure including disease progression or discontinuation of treatment for any reason or date of the last follow-up visit

Sponsor's own description

Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk patients with DLBCL Non-Hodgkin's lymphomas.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of progression-free or event-free survival with overall survival in diffuse large B-cell lymphoma after immunochemotherapy: a systematic review.
   Zhu J, Yang Y, Tao J, Wang SL, et al · · 2020 · cited 22× · PMID 32651542 · DOI 10.1038/s41375-020-0963-1
2. The identification of TCF1+ progenitor exhausted T cells in THRLBCL may predict a better response to PD-1/PD-L1 blockade.
   Tabanelli V, Melle F, Motta G, Mazzara S, et al · · 2022 · cited 14× · PMID 35767735 · DOI 10.1182/bloodadvances.2022007046
3. Predictive and Prognostic Molecular Factors in Diffuse Large B-Cell Lymphomas.
   Pileri SA, Tripodo C, Melle F, Motta G, et al · · 2021 · cited 13× · PMID 33803671 · DOI 10.3390/cells10030675
4. A three-gene signature based on <i>MYC</i>, <i>BCL-2</i> and <i>NFKBIA</i> improves risk stratification in diffuse large B-cell lymphoma.
   Derenzini E, Mazzara S, Melle F, Motta G, et al · · 2021 · cited 9× · PMID 32817282 · DOI 10.3324/haematol.2019.236455
5. The significance of upfront autologous stem cell transplantation for high-intermediate/high-risk stage IV diffuse large B-cell lymphoma.
   Koviazin AK, Filatova LV, Zyuzgin IS, Artemyeva AS, et al · · 2023 · cited 3× · PMID 36855295 · DOI 10.1002/cnr2.1786
6. Prediction of 5-year overall survival of diffuse large B-cell lymphoma on the pola-R-CHP regimen based on 2-year event-free survival and progression-free survival.
   Zhang WR, Liu X, Zhong QZ, Wu T, et al · · 2024 · cited 2× · PMID 38180169 · DOI 10.1002/cam4.6899
7. Physicians Abstracts.
   · 2016 · cited 1× · PMID 26999536 · DOI 10.1038/bmt.2016.46
8. Physicians Poster Sessions
   · 2014