Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2008-06-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
NCT00725231
The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
NCT00441025
Cyclophosphamide and Alemtuzumab In Lymphoma
NCT03132584
Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL
NCT00209222
The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL)
NCT00930605
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Medication: Patients are randomized to six cycles of two-weekly CHOP plus G-CSF with or without alemtuzumab given subcutaneously 30 mg day 1 in combination with chemotherapy cycles 1-4. Patients in CR, CRu and PR after the 6 cycles of CHOP14 combined or not with alemtuzumab will receive a consolidation with high-dose chemotherapy followed by autologous stem cell transplantation.
Patient Population: Patients \> 18 yrs with newly diagnosed non-cutaneous, non-leukemic PTCL, except alk-protein positive and negative anaplastic large cell lymphoma Planned Sample Size: 308 young patients (18-60 yrs) registered and randomized Total Number of Centers: This study will be proposed to main European and Australian Study Groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
6 cycles of CHOP every 2 weeks
Arm B
CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab
Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab
Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4
CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
6 cycles of CHOP every 2 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification:
* Peripheral T-cell lymphoma, unspecified (PTCL NOS)
* Angioimmunoblastic T-cell lymphoma
* Enteropathy-type T cell lymphoma
* Subcutaneous panniculitis-like T-NHL (gamma-delta T-cell lymphoma)
* Hepatosplenic T-cell lymphoma
* Extranodal NK/T cell lymphoma, nasal type
* Age 18-60 years at time of randomization
* Life expectancy of 3 months or longer
* ECOG performance status (PS) 0, 1 or 2 at the time of randomization. However, PS 3 will be acceptable if lymphoma-related.
* Measurable disease (defined as at least one lesion with two measurable perpendicular diameters of which at least one should be \>= 15 mm).
* Written informed consent
Exclusion Criteria
* Precursor T cell lymphoblastic lymphoma/leukemia
* All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL, HTLV1-pos ATL)
* Alk-positive and negative anaplastic large cell lymphoma
* Blastic NK cell lymphoma
* Cutaneous T-cell lymphoma, transformed or not
* Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.
* Known hypersensitivity to murine or chimeric antibodies or proteins
* Severe cardiac dysfunction (NYHA classification II-IV, Appendix H) or LVEF \< 45 %
* Significant renal dysfunction, i.e. serum creatinin \>2 times upper normal level (UNL), unless related to NHL
* Significant hepatic dysfunction (total bilirubin \>2 times UNL or transaminases \>= 2.5 times UNL), unless related to NHL
* Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmonary function test shows FEV1\<50% or a diffusion capacity \<50% of the reference values
* Suspected or documented Central Nervous System involvement by NHL
* Patients known to be HIV-positive
* Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg
* Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
* Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal or nasal type
* History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
* Unwillingness or inability to comply with the protocol
* Simultaneous participation in any other study protocol
* Pregnant and nursing women (Women of childbearing potential should use safe anticonceptives) Contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices and transdermal patches are considered as safe contraceptive methods).
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
OTHER
Aarhus University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco d'Amore, Prof
Role: PRINCIPAL_INVESTIGATOR
Dept. of Hematology, Århus University Hospital, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AKH Linz
Linz, , Austria
Krankenhaus der Elisabethinen
Linz, , Austria
Center for Clinical Cancer and Immunology Trials
Salzburg, , Austria
Hanusch Krankenhaus
Vienna, , Austria
ZNA Middelheim
Antwerp, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
AZ St Jan
Bruges, , Belgium
UZ VUB
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
Hôpital de Jolimont
Haine-St-Paul, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
CHR de la Citadelle
Liége, , Belgium
Clinique St Pierre
Ottignies, , Belgium
Heilig-Hartziekenhuis
Roeselare, , Belgium
Clinique de Mont-Godinne
Yvoir, , Belgium
University Hospital Brno
Brno, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
University Hospital Ostrava
Ostrava, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
Aalborg Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Vejle Hospital
Vejle, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Central Hospital
Turku, , Finland
Charite Universitätsmedizin Berlin
Berlin, , Germany
Krankenhaus Nordwest
Frankfurt, , Germany
University Hospital Regensburg
Regensburg, , Germany
Meander Medical Center
Amersfoort, , Netherlands
Vrije University Medical Center
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leids University Medical Center
Leiden, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
University Medical Center St. Radboud
Nijmegen, , Netherlands
Erasmus Medical Center - Centrum
Rotterdam, , Netherlands
Erasmus Medical Center Daniel
Rotterdam, , Netherlands
Haga Ziekenhuis, loc. Leyenburg
The Hague, , Netherlands
Isala Klinieken, Sophia
Zwolle, , Netherlands
Radium Hospital
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
University Hospital of Nothern Norway
Tromsø, , Norway
St. Olavs Hospital
Trondheim, , Norway
Marie Sklodowska-Curie Memorial Institute Cancer Center
Warsaw, , Poland
IPO Lisboa
Lisbon, , Portugal
IPO Porto
Porto, , Portugal
Sunderby Hospital
Luleå, , Sweden
Lund University Hospital
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Norrlands University Hospital
Umeå, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-006130-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.