Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma (PTCL-06)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01679860 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : September 6, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 (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 |

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:
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:
Other Name: Mab- Campath (Alemtuzumab) |
- Efficacy [ Time Frame: one year ]number of clinical responses
- 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.
- 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)
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | paolo corradini | fondazione IRCCS istituto nazionale tumori Milano |
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 |
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 |