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

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ClinicalTrials.gov Identifier: NCT01679860
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Description
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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).


Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Peripheral Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)
Study Start Date : November 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Alemtuzumab

Arms and Interventions
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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 Name: 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 Name: Mab- Campath (Alemtuzumab)


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy [ Time Frame: one year ]
    number of clinical responses


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679860


Locations
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Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: paolo corradini fondazione IRCCS istituto nazionale tumori Milano
More Information
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Responsible Party: Paolo Corradini, Director Hematology and BMT Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01679860    
Other Study ID Numbers: PTCL-062006-004234-33
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Alemtuzumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents