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| Sponsor: | Aarhus University Hospital |
|---|---|
| Collaborator: |
GCP-unit at Aarhus University Hospital, Aarhus, Denmark |
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00646854 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, T-Cell, Peripheral |
Drug: CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab Drug: CHOP14 chemotherapy (see specification under Arm B) plus G-CSF |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Young Patients With Previously Untreated Systemic Peripheral T-cell Lymphomas |
| Estimated Enrollment: | 308 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm A: Active Comparator |
Drug: CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
6 cycles of CHOP every 2 weeks
|
| Arm B: Experimental |
Drug: 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
|
First International phase III T-cell lymphoma study Indication:Newly diagnosed non-cutaneous peripheral T-cell lymphoma Study objectives:Determination of the efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with two-weekly CHOP supported by G-CSF Primary Endpoint: Event-Free-Survival (EFS) Study Design: International open-label, multicentre, randomized Phase III Study
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Francesco d'Amore, Associate Professor, Dr.med | + 45 8949 7567 | frandamo@rm.dk |
Show 38 Study Locations| Principal Investigator: | Francesco d'Amore, Associate Professor, Dr.med | Dept. of Hematology, Århus University Hospital, Denmark |
More Information
| Responsible Party: | Aarhus University Hospital ( Associate professor Francesco d'Amore ) |
| Study ID Numbers: | 2006-006130-17 |
| Study First Received: | February 14, 2008 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00646854 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency |
|
Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral MabCampath |
Campath CHOP-14 CD52 expression |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Lymphoma, T-Cell, Peripheral Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases |
Neoplasms Therapeutic Uses Lymphoma, T-Cell Alemtuzumab Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma |