Diffuse Large B-Cell LymphomaPhase 2DLBCLNCT00556127

Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

A Phase 2 study testing Rituximab, Epirubicin and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma and POOR PROGNOSIS, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 14 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

The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS
What is being tested?: Rituximab, Epirubicin and Cyclophosphamide
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 14 sitesItaly
Study dates: Jun 2002to Sep 2006
Phase: Phase 2
Are there results?: None posted in the registry

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,
Primary Mediastinal,
Follicular grade III b Lymphoma);
age 18 to 60;
III-IV Ann Arbor stage;
0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS);
intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI).
Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease.

Who cannot join

HIV,
hepatitis B or C virus seropositivity;
CNS involvement at diagnosis;
abnormal renal, pulmonary and hepatic function;
left ventricular ejection fraction less than 45%;
pregnancy.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Italy14 sites

Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Ospedale Regionale, Divisione di Oncologia,
Aosta
Azienda Ospedaliera Ospedale Policlinico Consorziale
Bari
Osp. degli Infermi
Biella
Spedali Civili
Brescia
Centro Trapianti Midollo Osseo, P.O. Businco
Cagliari
Ospedale S. Gerardo
Monza
Osp. maggiore della Carità
Novara
Università degli Studi Policlinico Monteluce
Perugia
Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo
Torino
Istituto per la Ricerca e la Cura del Cancro, Candiolo
Torino
Osp. S. Giovanni Battista "Molinette"
Torino
Ospedale di Chivasso e Ivrea
Torino
Stabilimento Ospedaliero Ciriè -
Torino

Other trials in Italy

About this study

Official title: Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

Conditions: Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS
Being tested: Rituximab, Epirubicin, Cyclophosphamide, Vincristine, Prednisone
Keywords: Large B-cell Lymphoma, Rituximab, ASCT
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.

RituximabDrug
375 mg/m2 on day 1
EpirubicinDrug
110 mg/m2 on day 3
CyclophosphamideDrug
1200 mg/m2 on day 3
VincristineDrug
1.4 mg/m2 (maximum 2 mg) on day 3
PrednisoneDrug
40 mg/m2 from day 1 to 5
Granulocyte-colony-stimulating factorDrug
(G-CSF 5 μg/Kg/day) from day 5 to day 11
MitoxantroneDrug
8 mg/m2 for 3-day
Cytarabine ARA-CDrug
2 g/m2/12 hours for six doses in 3-hour infusion
DexamethasoneDrug
4 mg/m2/12 hours before ARA-C administration
Carmustine BCNUDrug
300 mg/m2 on day -7
EtoposideDrug
100 mg/m2/12 hours
MelphalanDrug
140 mg/m2 on day -2
RadiotherapyRadiation
Involved Field Radiotherapy (IF-RT)
PBSC reinfusionProcedure or surgery
ASCT

Study groups in NCT00556127
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Rituximab; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Granulocyte-colony-stimulating factor; Drug: Mitoxantrone; Drug: Cytarabine ARA-C; Drug: Dexamethasone; Drug: Carmustine BCNU; Drug: Etoposide; Drug: Melphalan; Radiation: Radiotherapy; Procedure: PBSC reinfusion

What is being measured

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

Failure-free survival
Measured: Three years

Timeline

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

Jun 2002Sep 2006

First posted9 Nov 2007 (estimated)
Study startJun 2002
Study completionSep 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00556127
Sponsor's protocol ID: GIMURELL-DLBCL
Other IDs: Eudract Number 2004-000543-19
Acronym: DLBCL
Status last verified: Nov 2007
First submitted: 8 Nov 2007
Last updated: 9 Nov 2007
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of Oral MRT-2359 in Selected Cancer Patients
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Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma

All Diffuse Large B-Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive
ClinicalTrials.gov ID: NCT00556127
Acronym / sponsor ID: DLBCL / GIMURELL-DLBCL
Conditions: Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS
Keywords: Large B-cell Lymphoma, Rituximab, ASCT
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle LeucemieUniversity, hospital or other
Study start: Jun 2002
Study completion: Sep 2006 (actual)
First posted: 9 Nov 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Rituximab, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Prednisone, Drug: Granulocyte-colony-stimulating factor, Drug: Mitoxantrone, Drug: Cytarabine ARA-C, Drug: Dexamethasone, Drug: Carmustine BCNU, Drug: Etoposide, Drug: Melphalan, Radiation: Radiotherapy, Procedure: PBSC reinfusion

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,
Primary Mediastinal,
Follicular grade III b Lymphoma);
age 18 to 60;
III-IV Ann Arbor stage;

Key exclusion criteria (6 listed)

HIV,
hepatitis B or C virus seropositivity;
CNS involvement at diagnosis;
abnormal renal, pulmonary and hepatic function;
left ventricular ejection fraction less than 45%;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rituximab375 mg/m2 on day 1	Drug	1
Epirubicin110 mg/m2 on day 3	Drug	1
Cyclophosphamide1200 mg/m2 on day 3	Drug	1
Vincristine1.4 mg/m2 (maximum 2 mg) on day 3	Drug	1
Prednisone40 mg/m2 from day 1 to 5	Drug	1
Granulocyte-colony-stimulating factor(G-CSF 5 μg/Kg/day) from day 5 to day 11	Drug	1
Mitoxantrone8 mg/m2 for 3-day	Drug	1
Cytarabine ARA-C2 g/m2/12 hours for six doses in 3-hour infusion	Drug	1
Dexamethasone4 mg/m2/12 hours before ARA-C administration	Drug	1
Carmustine BCNU300 mg/m2 on day -7	Drug	1
Etoposide100 mg/m2/12 hours	Drug	1
Melphalan140 mg/m2 on day -2	Drug	1
RadiotherapyInvolved Field Radiotherapy (IF-RT)	Radiation	1
PBSC reinfusionASCT	Procedure or surgery	1

Primary outcome

Failure-free survival
Time frame: Three years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2007.

Related trials for Diffuse Large B-Cell Lymphoma

Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Umberto Vitolo, MD principal investigator

S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 6 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 9 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Failure-free survival (time frame: Three years). 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 NCT00556127.

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 9 Nov 2007.