Elderly Patients (>65 Years)Phase 3ANZINTER3NCT01148446
R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
A Phase 3 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Elderly Patients (>65 Years) and Diffuse Large B Cell Lymphoma (DLBCL), run by Fondazione Italiana Linfomi - ETS at 11 sites in Italy.
Trial summary
The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65 years) with Diffuse Large B Cell Lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 66 to 80 years
- Conditions the study is for
- Elderly Patients (>65 Years), Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Cyclophosphamide, Doxorubicin and Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 11 sitesItaly
- Study dates
- Jan 2003to Jan 2006
- Phase
- Phase 3
- 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 66 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".
- Patients were classified as "non frail" (fit) if they had
- ADL (Activity of Daily Living) score of 6
- less than three grade 3 Cumulative Illness Rating Score for Geriatrics (CIRS-G) co-morbidities and no grade 4 co-morbidities
- absence of geriatric syndrome
- Patients HIV negativity;
- Concurrent malignancy;
- Written Informed Consent.
Who cannot join
- All other patients were classified as "unfit", and were excluded from randomization
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
S.C. di Ematologia, Spedali Civili
Brescia, Brescia, 25123
Ospedale Garibaldi-Nesima
Catania
Ospedale civile Divisione di Ematologia
Civitanova Marche (MC)
Ospedale San Sebastiano
Correggio (RE)
Presidio Ospedaliero Annunziata
Cosenza
Istituto Vito Fazzi
Lecce
Azienda Ospedaliera Policlinico
Modena
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia
Ospedale civile DH oncologico
Sassuolo (MO)
Ospedale San Giovanni Battista - Molinette
Torino
Ospedale di Vigevano
Vigevano, Pavia
About this study
Official title: A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)
The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Epirubicin
- Keywords
- DLBCL, R-CHOP, R-CEOP, Elderly patients
- 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.
CyclophosphamideDrug
750 mg/mq IV, day 1
CyclophosphamideDrug
50 mg/mq IV, day 1
DoxorubicinDrug
50 mg/mq IV, day1
VincristineDrug
1,4 mg/mq (max 2 mg)IV, day 1
PrednisoneDrug
75 mg/mq IV, days 1-5
PrednisoneDrug
60 mg/mq IV/PO, days 1-5
EpirubicinDrug
50 mg/mq IV, day 1
VinblastineDrug
5 mg/mq IV, day 1
RituximabDrug
375 mg/mq IV, day 1
G-CSFDrug
300 µg tot., SC; days 7-11
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP | Experimental | R-CHOP (every 21 days) for six courses Cyclophosphamide: 750 mg/m2, IV, day 1 Doxorubicin: 50 mg/m2, IV, day 1 Vincristine: 1.4 (max 2) mg/m2, IV, day 1 Prednisone: 75 mg/m2, IV, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11 Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: G-CSF |
| R-mini-CEOP | Experimental | R-miniCEOP (every 21 days)for six courses Cyclophosphamide: 50 mg/m2, IV, day 1 Epirubicin: 50 mg/m2, IV, day 1 Vinblastine: 5 mg/m2, IV, day 1 Prednisone: 60 mg/m2, IV/PO, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11 Receives: Drug: Cyclophosphamide; Drug: Prednisone; Drug: Epirubicin; Drug: Vinblastine; Drug: Rituximab; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS)
Measured: 2 years
Secondary outcomes (3)
Complete Remission (CR) rate
Measured: 2 years
Disease Free Survival (DFS)
Measured: 2 years
Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2003
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elderly Patients (>65 Years)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Merli, MD, Study chair, U.O.A. di Ematologia Azienda Ospedale S. Maria NuovaMarilena Bertini, MD, Study chair, U.O.A. di Ematologia Ospedale Molinette
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148446
- Sponsor's protocol ID
- IIL ANZINTER3
- Acronym
- ANZINTER3
- Status last verified
- Jun 2010
- First submitted
- 21 Jun 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Shi Q, Schmitz N, Ou FS, Dixon JG, Cunningham D, Pfreundschuh M, Seymour JF, Jaeger U, Habermann TM, Haioun C, Tilly H, Ghesquieres H, Merli F, Ziepert M, Herbrecht R, Flament J, Fu T, Coiffier B, Flowers CR. Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Diffuse Large B-Cell Lymphoma: An Individual Patient-Level Analysis of Multiple Randomized Trials (SEAL). J Clin Oncol. 2018 Sep 1;36(25):2593-2602. doi: 10.1200/JCO.2018.77.9124. Epub 2018 Jul 5.
PubMed 29975624Merli F, Luminari S, Rossi G, Mammi C, Marcheselli L, Tucci A, Ilariucci F, Chiappella A, Musso M, Di Rocco A, Stelitano C, Alvarez I, Baldini L, Mazza P, Salvi F, Arcari A, Fragasso A, Gobbi PG, Liberati AM, Federico M. Cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab versus epirubicin, cyclophosphamide, vinblastine, prednisone and rituximab for the initial treatment of elderly "fit" patients with diffuse large B-cell lymphoma: results from the ANZINTER3 trial of the Intergruppo Italiano Linfomi. Leuk Lymphoma. 2012 Apr;53(4):581-8. doi: 10.3109/10428194.2011.621565. Epub 2011 Nov 15.
PubMed 21895543
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT01148446
- Acronym / sponsor ID
- ANZINTER3 / IIL ANZINTER3
- Keywords
- DLBCL, R-CHOP, R-CEOP, Elderly patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2006 (actual)
- First posted
- 22 Jun 2010 (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.
The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-CHOP | Experimental | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Rituximab, Drug: G-CSFR-CHOP (every 21 days) for six courses Cyclophosphamide: 750 mg/m2, IV, day 1 Doxorubicin: 50 mg/m2, IV, day 1 Vincristine: 1.4 (max 2) mg/m2, IV, day 1 Prednisone: 75 mg/m2, IV, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11 |
| R-mini-CEOP | Experimental | Drug: Cyclophosphamide, Drug: Prednisone, Drug: Epirubicin, Drug: Vinblastine, Drug: Rituximab, Drug: G-CSFR-miniCEOP (every 21 days)for six courses Cyclophosphamide: 50 mg/m2, IV, day 1 Epirubicin: 50 mg/m2, IV, day 1 Vinblastine: 5 mg/m2, IV, day 1 Prednisone: 60 mg/m2, IV/PO, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11 |
Who may qualify
- Ages
- 66 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".
- Patients were classified as "non frail" (fit) if they had
- Patients HIV negativity;
- Concurrent malignancy;
- Written Informed Consent.
Key exclusion criteria (1 listed)
- All other patients were classified as "unfit", and were excluded from randomization
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 |
|---|---|---|
| Cyclophosphamide750 mg/mq IV, day 1 | Drug | R-CHOP |
| Cyclophosphamide50 mg/mq IV, day 1 | Drug | R-mini-CEOP |
| Doxorubicin50 mg/mq IV, day1 | Drug | R-CHOP |
| Vincristine1,4 mg/mq (max 2 mg)IV, day 1 | Drug | R-CHOP |
| Prednisone75 mg/mq IV, days 1-5 | Drug | R-CHOP |
| Prednisone60 mg/mq IV/PO, days 1-5 | Drug | R-mini-CEOP |
| Epirubicin50 mg/mq IV, day 1 | Drug | R-mini-CEOP |
| Vinblastine5 mg/mq IV, day 1 | Drug | R-mini-CEOP |
| Rituximab375 mg/mq IV, day 1 | Drug | R-CHOP, R-mini-CEOP |
| G-CSF300 µg tot., SC; days 7-11 | Drug | R-CHOP, R-mini-CEOP |
Primary outcome
Event Free Survival (EFS)
Time frame: 2 years
3 secondary outcomes
Complete Remission (CR) rate
Time frame: 2 years
Disease Free Survival (DFS)
Time frame: 2 years
Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
Time frame: 2 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 22 Jun 2010.
- Derived from this study: PubMed 29975624Shi Q, Schmitz N, Ou FS, Dixon JG, Cunningham D, Pfreundschuh M, Seymour JF, Jaeger U, Habermann TM, Haioun C, Tilly H, Ghesquieres H, Merli F, Ziepert M, Herbrecht R, Flament J, Fu T, Coiffier B, Flowers CR. Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Diffuse Large B-Cell Lymphoma: An Individual Patient-Level Analysis of Multiple Randomized Trials (SEAL). J Clin Oncol. 2018 Sep 1;36(25):2593-2602. doi: 10.1200/JCO.2018.77.9124. Epub 2018 Jul 5.
- Derived from this study: PubMed 21895543Merli F, Luminari S, Rossi G, Mammi C, Marcheselli L, Tucci A, Ilariucci F, Chiappella A, Musso M, Di Rocco A, Stelitano C, Alvarez I, Baldini L, Mazza P, Salvi F, Arcari A, Fragasso A, Gobbi PG, Liberati AM, Federico M. Cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab versus epirubicin, cyclophosphamide, vinblastine, prednisone and rituximab for the initial treatment of elderly "fit" patients with diffuse large B-cell lymphoma: results from the ANZINTER3 trial of the Intergruppo Italiano Linfomi. Leuk Lymphoma. 2012 Apr;53(4):581-8. doi: 10.3109/10428194.2011.621565. Epub 2011 Nov 15.
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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.
Francesco Merli, MD study chair
U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
Marilena Bertini, MD study chair
U.O.A. di Ematologia Ospedale Molinette
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Elderly Patients (>65 Years) and Diffuse Large B Cell Lymphoma (DLBCL), run by Fondazione Italiana Linfomi - ETS at 11 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 8 inclusion and 1 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 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Event Free Survival (EFS) (time frame: 2 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 NCT01148446, which also lists 2 linked publications.
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 22 Jun 2010.