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

NCT01679860 | Completed Phase 2 DMC

• 1 other identifier: PTCL-062006-004234-33
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 17

Brief 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. 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).

Conditions

Lymphoma, T-Cell, Peripheral

Outcome Measures

Primary Outcomes (1)

• Efficacy

  number of clinical responses

  one year

Secondary Outcomes (3)

• evaluation of OS (overall survival)

  4 years

• DFS (Disease Free Survival)

  4 years

• TRM (Treatment Related Mortality)

  4 years

Study Arms (2)

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

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

Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy

Interventions

Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT PROCEDURE

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.

Also known as: Mab - Campath (Alemtuzumab)

Clin A

Clin B (CHOP- CAMPATH) Chemo-immunotherapy DRUG

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.

Also known as: Mab- Campath (Alemtuzumab)

Clin B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (17)

Spedali Civili di Brescia

Brescia, Brescia, 25123, Italy

Location

Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania

Catania, Catania, 94124, Italy

Location

Ospedale San Carlo

Potenza, Potenza, 85100, Italy

Location

Azienda Ospedaliera S. Luigi

Orbassano, Torino, 10043, Italy

Location

Azienda OspedalieraSan Giovanni Battista

Torino, Torino, 10126, Italy

Location

Università di Torino- Azienda Ospedaliera S. Giovanni Battista

Torino, Torino, 10126, Italy

Location

Policlinico Universitario Udine

Udine, Udine, Italy

Location

Ospedale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, 15100, Italy

Location

University of Ancona - Division of Hematology

Ancona, 62020, Italy

Location

Ospedale Riuniti, Bergamo - Division of Hematology

Bergamo, 24128, Italy

Location

Ospedale Generale Regionale Bolzano

Bolzano, 39100, Italy

Location

Ospedale S. Croce - Division of Hematology

Cuneo, 12100, Italy

Location

Ospedale San Raffaele, Milano - Division of Hematology

Milan, 20100, Italy

Location

Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

IRCCS Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Ospedale Cervello - Bone Marrow Transplantation Unit

Palermo, Italy

Location

Azienda Ospedaliera Policlinico di Verona

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• paolo corradini

  fondazione IRCCS istituto nazionale tumori Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Hematology and BMT Unit

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 6, 2012
• Study Start: November 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

IT (17)