Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.
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
1 other identifier
interventional
246
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2005
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 20, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
August 10, 2017
CompletedAugust 10, 2017
August 1, 2017
7.8 years
July 20, 2006
March 16, 2017
August 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival
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
36 months from end of therapy
Secondary Outcomes (5)
Complete Remission
Through therapy completion an average of 8 months
Disease Free Survival
36 months from end of therapy
Overall Survival
36 months from end of therapy
Toxicity
Through therapy completion an average of 8 months
Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14
Through completion of salvage therapy
Study Arms (2)
R-HDS
EXPERIMENTALR-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.
R-CHOP
ACTIVE COMPARATORRituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).
Interventions
Rituximab-HDS
Rituximab-CHOP
Eligibility Criteria
You may qualify if:
- Diagnosis of DLBCL CD20+.
- Patients with Ann Arbor classification B-bulk \>= II
- Patients of age between 18-65 with age-adjusted IPI 2-3 and ECOG performance status 0-3 or patients of age 61-65 with IPI 3, 4, 5 and ECOG performance status 0-2. The disease stage criteria must be documented with instrumental examinations and bone marrow biopsy.
- Hematology parameters one week before starting study as follows: Hb \>= 9 g/dl, WBC \>= 3 x 10exp9/l, neutrophils \>= 1.5 x 10exp9/l, PLT \>= 100 x 10exp9/l.
- Patients with pulmonary DLCO \>= 50% and cardiac EF \>= 40%.
- Voluntary written informed consent must be signed before recruitment, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Patients must to be informed on the risk of sterility and they must agree to use contraception for the duration of the study. Male subject have to the opportunity of freezing seminal fluid.
You may not qualify if:
- Diagnosis different from that describe above.
- Patients with concomitant, serious and uncontrolled illnesses such as cardiopathies (i.e. congestive cardiopathy, ischemic hearth disease, cardiac arrhythmia not controlled by therapy, IMA in the last six months, hearth disease NYHA class III or IV), hepatopathy not related to the lymphoma (bilirubin \>= 2 mg/dl, ALT \>= 2.5 times the normal value, alkaline phosphatase \>=2.5 times the upper limit), kidneys insufficiency not related to the lymphoma (creatinine \>=2 mg/dl).
- Patients affected by opportunistic infections or with positive serology for HIV, HCV, HbsAg (cases with normal levels of hepatic enzymes and not showing active viral replication documented with HBV-DNA are not excluded from randomization; patients with HBV+ can be enrolled after receiving prophylaxis with lamivudina one week before starting chemotherapy. These patients should be monitored twice a month for HbsAg, HBCab, HBV-DNA).
- Patients which have or have had another type of cancer exception made for skin cancers (melanoma and "in situ" cervical cancer not included).
- Patient with a history of anaphylaxes or more generally patients which have had any serious allergic reaction after serum infusion.
- Patient with uncontrolled epilepsy, CNS disorders or psychiatric problems which, according to the investigator, is likely to interfere with participation in this clinical study (i.e. the signing of the informed consent, therapy compliance).
- Inability to attend follow-up visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Clinica di Ematologia - Nuovo Ospedale Torrette
Ancona, Italy
U.O. Ematologia - Ospedali Riuniti di Bergamo
Bergamo, Italy
Divisione di Ematologia - Ospedale Centrale di Bolzano
Bolzano, Italy
CTMO - Ematologia - Ospedale "R. Binaghi"
Cagliari, Italy
Divisione di Ematologia - Ospedale Ferrarotto
Catania, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Divisione Ematologia - Istituto S. Raffaele
Milan, Italy
Oncologia Medica - Istituto Nazionale dei Tumori
Milan, Italy
U.O. Ematologia - Istituto Nazionale dei Tumori
Milan, Italy
Divisione di Ematologia - Azienda Ospedaliera
Padua, Italy
Ematologia - Azienda Ospedaliera V. Cervello
Palermo, Italy
Ematologia Clinica - Ospedale Civile di Pescara
Pescara, Italy
Ematologia e TMO - Ospedale S. Camillo
Roma, Italy
Divisione Universitaria di Ematologia - Azienda Ospedaliera S. Giovanni Battista (Molinette)
Torino, Italy
Dipartimento di Medicina Clinica e Sperimentale - Università di Verona
Verona, Italy
Divisione di Ematologia - Presidio Ospedaliero S. Bortolo
Vicenza, Italy
Related Publications (1)
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.
PMID: 32817282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alessandro Rambaldi
- Organization
- Ospedale Papa Giovanni XXIII, Bergamo
Study Officials
- STUDY CHAIR
Sergio Cortelazzo, MD
Divisione di Ematologia - Ospedale Centrale di Bolzano - 39100 Bolzano Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2006
First Posted
July 21, 2006
Study Start
May 1, 2005
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 10, 2017
Results First Posted
August 10, 2017
Record last verified: 2017-08