Completed PHASE3 INTERVENTIONAL 2-arm NCT00646854

Alemtuzumab and CHOP in T-cell Lymphoma (ACT-1)

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

Sponsor: Aarhus University Hospital

Conditions Lymphoma, T-Cell, Peripheral

Interventions CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab CHOP14 chemotherapy (see specification under Arm B) plus G-CSF

Updated 8 times since 2017 Last updated: Feb 27, 2019 Started: Jun 30, 2008 Primary completion: Dec 31, 2016 Completion: Dec 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Lymphoma, T-Cell, Peripheral and is currently completed. Aarhus University Hospital leads this study, which shows 8 recorded versions since 2008 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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.

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.

Status Flow

Change History

8 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE3
Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Apr 2019 — Jan 2021 [monthly]

Completed PHASE3

Status: Unknown Status → Completed
Jun 2018 — Apr 2019 [monthly]

Unknown Status PHASE3
Jan 2017 — Jun 2018 [monthly]

Unknown Status PHASE3

First recorded

Jun 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Aarhus University Hospital
GCP-unit at Aarhus University Hospital, Aarhus, Denmark

Data source: University of Aarhus

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalborg, Denmark , Aarhus, Denmark , Amersfoort, Netherlands , Amsterdam, Netherlands , Antwerp, Belgium , Berlin, Germany , Brno, Czechia , Bruges, Belgium , Brussels, Belgium , Charleroi, Belgium and 43 more locations