Alemtuzumab and CHOP in T-cell Lymphoma

NCT00646854 | Completed Phase 3 DMC

• 1 other identifier: 2006-006130-17
• Study Type: interventional
• Target: 136
• Locations: 11 countries
• Sites: 59

Brief Summary

The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; MabCampath; Campath; CHOP-14; CD52 expression

Outcome Measures

Primary Outcomes (1)

• Event-free Survival

  The EFS is defined by the time between day of randomization until an event occurs, up to 96 months

Secondary Outcomes (6)

• Overall survival

  From the time of randomisation to date of last follow-up or death, up to 96 months

• Overall response rate

  from date of randomization to date of primary response assessment, up to 96 months

• Overall response rate related to the CD52 expression

  From date of randomization to date of primary response assessment, up to 96 months

• Tumor control or time-to-progression

  time of randomization to last follow-up or time of disease progression, up to 96 months

• Safety measured as number of adverse events (AEs) and serious adverse events (SAEs)

  from randomization to closure of study, up to 96 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Drug: CHOP14 chemotherapy (see specification under Arm B) plus G-CSF

Arm B

EXPERIMENTAL

Drug: CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab

Interventions

CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab DRUG

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

Arm B

CHOP14 chemotherapy (see specification under Arm B) plus G-CSF DRUG

6 cycles of CHOP every 2 weeks

Arm A

Eligibility Criteria

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

You may qualify if:

• Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (≥ 7.5 cm) and stages II to IV.
• 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

You may not qualify if:

• Patients with NK/T-NHL of the following type:
• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• GCP-unit at Aarhus University Hospital, Aarhus, Denmark: collaborator

Study Sites (59)

AKH Linz

Linz, 4020, Austria

Location

Krankenhaus der Elisabethinen

Linz, 4020, Austria

Location

Center for Clinical Cancer and Immunology Trials

Salzburg, 5020, Austria

Location

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

ZNA Stuivenberg

Antwerp, 2020, Belgium

Location

AZ St Jan

Bruges, 8000, Belgium

Location

UZ VUB

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

Hôpital de Jolimont

Haine-St-Paul, 7100, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

CHR de la Citadelle

Liége, 4000, Belgium

Location

Clinique St Pierre

Ottignies, 1340, Belgium

Location

Heilig-Hartziekenhuis

Roeselare, 8800, Belgium

Location

Clinique de Mont-Godinne

Yvoir, 5530, Belgium

Location

University Hospital Brno

Brno, 625 00, Czechia

Location

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, 100 34, Czechia

Location

University Hospital Motol

Prague, 150 00, Czechia

Location

Aalborg Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Herlev Hospital

Herlev, DK-2730, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Vejle Hospital

Vejle, DK-7100, Denmark

Location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Oulu University Hospital

Oulu, 90029, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University Central Hospital

Turku, 20521, Finland

Location

Charite Universitätsmedizin Berlin

Berlin, D-13353, Germany

Location

Krankenhaus Nordwest

Frankfurt, D-60488, Germany

Location

University Hospital Regensburg

Regensburg, D-93042, Germany

Location

Meander Medical Center

Amersfoort, NL-3800 BM, Netherlands

Location

Vrije University Medical Center

Amsterdam, NL-1007 MB, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, NL-1100 DD, Netherlands

Location

Medisch Spectrum Twente

Enschede, NL-7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, NL-9700 RB, Netherlands

Location

Leids University Medical Center

Leiden, NL-2300 RC, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, NL-6202 AZ, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, NL-3430 EM, Netherlands

Location

University Medical Center St. Radboud

Nijmegen, NL-6500 HB, Netherlands

Location

Erasmus Medical Center - Centrum

Rotterdam, NL-3075 EA, Netherlands

Location

Erasmus Medical Center Daniel

Rotterdam, NL-3075 EA, Netherlands

Location

Haga Ziekenhuis, loc. Leyenburg

The Hague, NL-2504 LN, Netherlands

Location

Isala Klinieken, Sophia

Zwolle, NL-8000 GK, Netherlands

Location

Radium Hospital

Oslo, N-0310, Norway

Location

Stavanger University Hospital

Stavanger, N-4068, Norway

Location

University Hospital of Nothern Norway

Tromsø, N-9038, Norway

Location

St. Olavs Hospital

Trondheim, N-7030, Norway

Location

Marie Sklodowska-Curie Memorial Institute Cancer Center

Warsaw, 02-781, Poland

Location

IPO Lisboa

Lisbon, 1099-023, Portugal

Location

IPO Porto

Porto, 4200-072, Portugal

Location

Sunderby Hospital

Luleå, S-971 80, Sweden

Location

Lund University Hospital

Lund, S-221 85, Sweden

Location

Karolinska University Hospital

Stockholm, S-141 86, Sweden

Location

Norrlands University Hospital

Umeå, S-901 85, Sweden

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Alemtuzumab

Condition Hierarchy (Ancestors)

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Francesco d'Amore, Prof

  Dept. of Hematology, Århus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: March 31, 2008
• Study Start: June 1, 2008
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

SE (4); NO (4); PT (2); AU (4); BE (12); CZ (5); DK (6); FI (5); NL (13); PL (1); DE (3)