Lymphoma, T-Cell, PeripheralPhase 2PTCL-06NCT01679860
Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma
A Phase 2 study testing Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT and Clin B (CHOP- CAMPATH) Chemo-immunotherapy in people with Lymphoma, T-Cell, Peripheral, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 17 sites in Italy.
Trial summary
Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT and Clin B (CHOP- CAMPATH) Chemo-immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 17 sitesItaly
- Study dates
- Nov 2006to Aug 2012
- 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
- Age ≥18 <60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
- Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
- Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Written informed consent
Who cannot join
- Histological PTCL subset other than PTCL-U, AILD-T ALCL-ALKneg, intestinal T - NHL
- Central nervous system localization
- Positive serologic markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection
- Serum bilirubin levels > 2 the upper normal limit
- Clearance of creatinine < 50 ml/min
- DLCO < 50%
Show all 13Show fewer
- Ejection fraction < 45% (or myocardial infarction in the last 12 months)
- Pregnancy or lactation
- Patient not agreeing to take adequate contraceptive measures during the study
- Psychiatric disease
- Any active, uncontrolled infection
- Type I hypersensitivity or anaphylactic reactions to proteins drugs
- Active secondary malignancy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites
Ospedale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, 15100
University of Ancona - Division of Hematology
Ancona, 62020
Ospedale Riuniti, Bergamo - Division of Hematology
Bergamo, 24128
Ospedale Generale Regionale Bolzano
Bolzano, 39100
Spedali Civili di Brescia
Brescia, Brescia, 25123
Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania
Catania, Catania, 94124
Ospedale S. Croce - Division of Hematology
Cuneo, 12100
Ospedale San Raffaele, Milano - Division of Hematology
Milan, 20100
Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori
Milan, 20133
IRCCS Ospedale Maggiore Policlinico di Milano
Milan, 20122
Azienda Ospedaliera S. Luigi
Orbassano, Torino, 10043
Ospedale Cervello - Bone Marrow Transplantation Unit
Palermo
Ospedale San Carlo
Potenza, Potenza, 85100
Azienda OspedalieraSan Giovanni Battista
Torino, Torino, 10126
Università di Torino- Azienda Ospedaliera S. Giovanni Battista
Torino, Torino, 10126
Policlinico Universitario Udine
Udine, Udine
Azienda Ospedaliera Policlinico di Verona
Verona, 37134
About this study
Official title: Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)
Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related toxicity and mortality. The investigators have recently proved feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients.
We want to investigate whether it is possible to improve the outcome of alk negative PTCL pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.
The intensification will be obtained by combining intensive chemotherapy, alemtuzumab (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between 61 and 70 years(Clinical Study B).
Read the detailed description
Inclusion criteria Clin A
- Age ≥18 < or =60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
- Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
- Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Written informed consent
Inclusion criteria Clin B
- Age >60 and ≤75 years (patients older than 75 years are excluded because of the intensive chemo-immunotherapy program)
- Histological proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma), intestinal T - NHL
- Advanced-stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Informed written consent
In clinical study A (Clin A) we are planning to evaluate the efficacy and the feasibility of an intensified chemo-immunotherapy program including auto-SCT or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and < or = 60 years.
In clinical study B (Clin B) we intend to verify the efficacy and the feasibility of a combined immuno-chemotherapy approach in a subset of elderly pts aged > 60 and < or = 75 years.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT, Clin B (CHOP- CAMPATH) Chemo-immunotherapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCTProcedure or surgery
Also called Mab - Campath (Alemtuzumab)
Clin A:
- CHOP-Campath (CHOP-C) for 2 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO on days +1 to +5; Campath-1H (alemtuzumab) dose escalation 3-10-20mg IV days - 2, - 1, 0 (first CHOP-C) or 30mg SC day 0 (second CHOP-C). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on days + 1 and 21 (first and second CHOP-C).
- HYPER-C-HiDAM for 2 cycles: Methotrexate 1.5gr/m2 day +1; Cyclophosphamide 300mg/m2 every 12 hours days +2-3-4; ARA-C 2gr/m2 every 12 hours days +2-3-4; G-CSF 5μcg/kg/day starting from day +5 until peripheral blood stem cell harvest
- Myeloablative regimen followed by autologous transplantation or Reduced intensity conditioning followed by allogeneic transplantation.
Clin B (CHOP- CAMPATH) Chemo-immunotherapyDrug
Also called Mab- Campath (Alemtuzumab)
Clin B:
- CHOP-Campath (CHOP-C) for 6 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO from day +1 to day +5¸ Campath-1H (alemtuzumab) 3-10mg IV on days - 1 and 0 ( first CHOP-C course) or 10mg SC on day 0 (for the following 5 C-CHOP courses). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on day +1 of each CHOP-C course.
| Study group | Role | What they receive |
|---|---|---|
| Clin A | Experimental | Clin A. CHOP-Campath (CHOP-C) for 2 cycles , Hyper-C-Hidam for 2 cycles and auto-SCT (stem cell transplantation) or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and ≤ 60 years Receives: Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT |
| Clin B | Experimental | Clin B: CHOP-Campath (CHOP-C) for 6 cycles . It is a combined immunochemotherapy approach in a subset of elderly pts aged > 60 ≤ 75 years Receives: Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
number of clinical responses
Measured: one year
Secondary outcomes (3)
evaluation of OS (overall survival)
OS time is calculated from patients enrollment to death for all causes; censored cases are pts alive at the date of last follow-up assessment.
Measured: 4 years
DFS (Disease Free Survival)
DFS time is the interval between CR achievement and the first disease relapse or death regardless of the cause.Definition of disease response/progression will be performed according to the criteria published by Juweid et al.(J Clin Oncol. 2005; 23: 4652-61)
Measured: 4 years
TRM (Treatment Related Mortality)
TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startNov 2006
- Primary completionDec 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- paolo corradini, Principal investigator, fondazione IRCCS istituto nazionale tumori Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679860
- Sponsor's protocol ID
- PTCL-062006-004234-33
- Acronym
- PTCL-06
- Status last verified
- Sep 2012
- First submitted
- 30 Aug 2012
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT01679860
- Acronym / sponsor ID
- PTCL-06 / PTCL-062006-004234-33
- Conditions
- Lymphoma, T-Cell, Peripheral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Sep 2012 (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.
Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related toxicity and mortality. The investigators have recently proved feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients.
We want to investigate whether it is possible to improve the outcome of alk negative PTCL pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.
The intensification will be obtained by combining intensive chemotherapy, alemtuzumab (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between 61 and 70 years(Clinical Study B).
Detailed description
Inclusion criteria Clin A
- Age ≥18 < or =60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
- Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
- Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Written informed consent
Inclusion criteria Clin B
- Age >60 and ≤75 years (patients older than 75 years are excluded because of the intensive chemo-immunotherapy program)
- Histological proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma), intestinal T - NHL
- Advanced-stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Informed written consent
In clinical study A (Clin A) we are planning to evaluate the efficacy and the feasibility of an intensified chemo-immunotherapy program including auto-SCT or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and < or = 60 years.
In clinical study B (Clin B) we intend to verify the efficacy and the feasibility of a combined immuno-chemotherapy approach in a subset of elderly pts aged > 60 and < or = 75 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clin A | Experimental | Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCTClin A. CHOP-Campath (CHOP-C) for 2 cycles , Hyper-C-Hidam for 2 cycles and auto-SCT (stem cell transplantation) or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and ≤ 60 years |
| Clin B | Experimental | Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapyClin B: CHOP-Campath (CHOP-C) for 6 cycles . It is a combined immunochemotherapy approach in a subset of elderly pts aged > 60 ≤ 75 years |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥18 <60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
- Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
- Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Written informed consent
Key exclusion criteria (13 listed)
- Histological PTCL subset other than PTCL-U, AILD-T ALCL-ALKneg, intestinal T - NHL
- Central nervous system localization
- Positive serologic markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection
- Serum bilirubin levels > 2 the upper normal limit
- Clearance of creatinine < 50 ml/min
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 |
|---|---|---|
| Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCTAlso: Mab - Campath (Alemtuzumab)Clin A: * CHOP-Campath (CHOP-C) for 2 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO on days +1 to +5; Campath-1H (alemtuzumab) dose escalation 3-10-20mg IV days - 2, - 1, 0 (first CHOP-C) or 30mg SC day 0 (second CHOP-C). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on days + 1 and 21 (first and second CHOP-C). * HYPER-C-HiDAM for 2 cycles: Methotrexate 1.5gr/m2 day +1; Cyclophosphamide 300mg/m2 every 12 hours days +2-3-4; ARA-C 2gr/m2 every 12 hours days +2-3-4; G-CSF 5μcg/kg/day starting from day +5 until peripheral blood stem cell harvest * Myeloablative regimen followed by autologous transplantation or Reduced intensity conditioning followed by allogeneic transplantation. | Procedure or surgery | Clin A |
| Clin B (CHOP- CAMPATH) Chemo-immunotherapyAlso: Mab- Campath (Alemtuzumab)Clin B: * CHOP-Campath (CHOP-C) for 6 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO from day +1 to day +5¸ Campath-1H (alemtuzumab) 3-10mg IV on days - 1 and 0 ( first CHOP-C course) or 10mg SC on day 0 (for the following 5 C-CHOP courses). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on day +1 of each CHOP-C course. | Drug | Clin B |
Primary outcome
Efficacy
Time frame: one year
number of clinical responses
3 secondary outcomes
evaluation of OS (overall survival)
Time frame: 4 years
DFS (Disease Free Survival)
Time frame: 4 years
TRM (Treatment Related Mortality)
Time frame: 4 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 6 Sep 2012.
Related trials for Lymphoma, T-Cell, Peripheral
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
Not yet recruitingPhase 2
Allogeneic Cell Therapy in Refractory T-Cell Lymphoma
Lymphoma, T Cell, Peripheral
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.
paolo corradini principal investigator
fondazione IRCCS istituto nazionale tumori Milano
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT and Clin B (CHOP- CAMPATH) Chemo-immunotherapy in people with Lymphoma, T-Cell, Peripheral, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 17 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 4 inclusion and 13 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 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Efficacy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2012.