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Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.

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ClinicalTrials.gov Identifier: NCT00355199
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Terapie Innovative nei Linfomi

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: Rituximab-HDS Drug: Rituximab-CHOP Phase 3

Detailed Description:

Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic survival curve with patients in complete remission (which can be considered cured) and patients that relapse. This last group of subjects have only 25%-33% chance of long free disease survival if treated with a second line therapy with high dose chemotherapy plus autologous transplant of PBPC.

Therefore in order to achieve an improvement of the overall survival in patient with DLBCL, it is necessary to increase the number of complete remission after first line therapy.

The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2005
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: R-HDS
R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.
Drug: Rituximab-HDS
Rituximab-HDS
Other Name: Rituximab supplemented high-dose sequential chemotherapy.

Active Comparator: R-CHOP
Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).
Drug: Rituximab-CHOP
Rituximab-CHOP
Other Name: Rituximab/Cyclophosph/doxorubic/vincrist/prednis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Complete Remission [ Time Frame: Through therapy completion an average of 8 months ]
    Clinical response was assessed by complete restaging according to Cheson criteria. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-86, 2007

  2. Disease Free Survival [ Time Frame: 36 months from end of therapy ]
    DFS was defined from the time of documentation of CR to time to relapse or death as a result of lymphoma or acute toxicity of treatment or date of the last follow-up visit

  3. Overall Survival [ Time Frame: 36 months from end of therapy ]
    OS was defined from the time of the study entry to death as a result of any cause or date of the last follow-up visit

  4. Toxicity [ Time Frame: Through therapy completion an average of 8 months ]
    Percentage of participants with at least one reported episode of CTC grade III or IV toxic events

  5. Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14 [ Time Frame: Through completion of salvage therapy ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355199


Locations
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Italy
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
Milano, Italy
Oncologia Medica - Istituto Nazionale dei Tumori
Milano, Italy
U.O. Ematologia - Istituto Nazionale dei Tumori
Milano, Italy
Divisione di Ematologia - Azienda Ospedaliera
Padova, 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
Sponsors and Collaborators
Gruppo Italiano Terapie Innovative nei Linfomi
Investigators
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Study Chair: Sergio Cortelazzo, MD Divisione di Ematologia - Ospedale Centrale di Bolzano - 39100 Bolzano Italy
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Responsible Party: Gruppo Italiano Terapie Innovative nei Linfomi
ClinicalTrials.gov Identifier: NCT00355199    
Other Study ID Numbers: EUDRACT: 2005-00700-14
First Posted: July 21, 2006    Key Record Dates
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017
Last Verified: August 2017
Keywords provided by Gruppo Italiano Terapie Innovative nei Linfomi:
DLBCL
R-HDS
R-CHOP14
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents