Skip to main content
OpenTrials
Completed

NCT Number: NCT01679860

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spedali Civili di Brescia, Brescia, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mab - Campath (Alemtuzumab)

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.

Other names: Mab- Campath (Alemtuzumab)

Primary outcomes

  1. Efficacy

    Time frame: one year

    number of clinical responses

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)

Acronym: PTCL-06

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Sep 6, 2012
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.