Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma (PTCL-06)

September 3, 2012 updated by: Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15100
        • Ospedale SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy, 62020
        • University of Ancona - Division of Hematology
      • Bergamo, Italy, 24128
        • Ospedale Riuniti, Bergamo - Division of Hematology
      • Bolzano, Italy, 39100
        • Ospedale Generale Regionale Bolzano
      • Brescia, Italy, 25123
        • Spedali Civili di Brescia
      • Catania, Italy, 94124
        • Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania
      • Cuneo, Italy, 12100
        • Ospedale S. Croce - Division of Hematology
      • Milan, Italy, 20100
        • Ospedale San Raffaele, Milano - Division of Hematology
      • Milan, Italy, 20133
        • Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori
      • Milano, Italy, 20122
        • IRCCS Ospedale Maggiore Policlinico di Milano
      • Palermo, Italy
        • Ospedale Cervello - Bone Marrow Transplantation Unit
      • Potenza, Italy, 85100
        • Ospedale San Carlo
      • Torino, Italy, 10126
        • Azienda OspedalieraSan Giovanni Battista
      • Torino, Italy, 10126
        • Università di Torino- Azienda Ospedaliera S. Giovanni Battista
      • Udine, Italy
        • Policlinico Universitario Udine
      • Verona, Italy, 37134
        • Azienda Ospedaliera Policlinico di Verona
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Azienda Ospedaliera S. Luigi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clin A
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
Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT

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.
Other Names:
  • Mab - Campath (Alemtuzumab)
Experimental: Clin B
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
Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy

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.
Other Names:
  • Mab- Campath (Alemtuzumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: one year
number of clinical responses
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of OS (overall survival)
Time Frame: 4 years
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.
4 years
DFS (Disease Free Survival)
Time Frame: 4 years
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)
4 years
TRM (Treatment Related Mortality)
Time Frame: 4 years
TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: paolo corradini, Fondazione IRCCS Istituto Nazionale Tumori Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTCL-062006-004234-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma, T-Cell, Peripheral

Clinical Trials on Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe