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AzTrials

Diffuse Large B-Cell LymphomaPhase 3NCT00355199

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

A Phase 3 study testing Rituximab-HDS and Rituximab-CHOP in people with Diffuse Large B-Cell Lymphoma, run by Gruppo Italiano Terapie Innovative nei Linfomi at 16 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Rituximab-HDS and Rituximab-CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
16 sitesItaly
Study dates
May 2005to Mar 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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  • Voluntary written informed consent must be signed before recruitment, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • Clinica di Ematologia - Nuovo Ospedale Torrette

    Ancona

  • U.O. Ematologia - Ospedali Riuniti di Bergamo

    Bergamo

  • Divisione di Ematologia - Ospedale Centrale di Bolzano

    Bolzano

  • CTMO - Ematologia - Ospedale "R. Binaghi"

    Cagliari

  • Divisione di Ematologia - Ospedale Ferrarotto

    Catania

  • S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

    Cuneo

  • Divisione Ematologia - Istituto S. Raffaele

    Milan

  • Oncologia Medica - Istituto Nazionale dei Tumori

    Milan

  • U.O. Ematologia - Istituto Nazionale dei Tumori

    Milan

  • Divisione di Ematologia - Azienda Ospedaliera

    Padova

  • Ematologia - Azienda Ospedaliera V. Cervello

    Palermo

  • Ematologia Clinica - Ospedale Civile di Pescara

    Pescara

  • Ematologia e TMO - Ospedale S. Camillo

    Roma

  • Divisione Universitaria di Ematologia - Azienda Ospedaliera S. Giovanni Battista (Molinette)

    Torino

  • Dipartimento di Medicina Clinica e Sperimentale - Università di Verona

    Verona

  • Divisione di Ematologia - Presidio Ospedaliero S. Bortolo

    Vicenza

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Rituximab-HDS, Rituximab-CHOP
Keywords
DLBCL, R-HDS, R-CHOP14
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab-HDSDrug

    Also called Rituximab supplemented high-dose sequential chemotherapy.

    Rituximab-HDS

  • Rituximab-CHOPDrug

    Also called Rituximab/Cyclophosph/doxorubic/vincrist/prednis

    Rituximab-CHOP

Study groups in NCT00355199
Study groupRoleWhat they receive
R-HDSExperimentalR-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.
Receives: Drug: Rituximab-HDS
R-CHOPActive comparatorRituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).
Receives: Drug: Rituximab-CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 36 months from end of therapy

Secondary outcomes (5)

  1. Complete Remission

    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

    Measured: Through therapy completion an average of 8 months

  2. Disease Free Survival

    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

    Measured: 36 months from end of therapy

  3. Overall Survival

    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

    Measured: 36 months from end of therapy

  4. Toxicity

    Percentage of participants with at least one reported episode of CTC grade III or IV toxic events

    Measured: Through therapy completion an average of 8 months

  5. Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14

    Measured: Through completion of salvage therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355199
Sponsor's protocol ID
EUDRACT: 2005-00700-14
Status last verified
Aug 2017
First submitted
20 Jul 2006
Last updated
10 Aug 2017
Data monitoring committee
No

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.

    PubMed 32817282

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab-HDS and Rituximab-CHOP in people with Diffuse Large B-Cell Lymphoma, run by Gruppo Italiano Terapie Innovative nei Linfomi at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: 36 months from end of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355199, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.

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