Lymphoma, T-Cell, PeripheralPhase 3ACT-1NCT00646854
Alemtuzumab and CHOP in T-cell Lymphoma
A Phase 3 study testing CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab and CHOP14 chemotherapy (see specification under Arm B) plus G-CSF in people with Lymphoma, T-Cell, Peripheral, run by Aarhus University Hospital at 59 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab and CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 59 sitesin 11 countries
- Study dates
- Jun 2008to 31 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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).
Trial locations and contacts
59 sites in 11 countries.
59 sites in 11 countries
Netherlands13 sites
Meander Medical Center
Amersfoort, NL-3800 BM
Vrije University Medical Center
Amsterdam, NL-1007 MB
Academisch Medisch Centrum
Amsterdam, NL-1100 DD
Medisch Spectrum Twente
Enschede, NL-7500 KA
University Medical Center Groningen
Groningen, NL-9700 RB
Leids University Medical Center
Leiden, NL-2300 RC
Academisch Ziekenhuis Maastricht
Maastricht, NL-6202 AZ
Sint Antonius Ziekenhuis
Nieuwegein, NL-3430 EM
University Medical Center St. Radboud
Nijmegen, NL-6500 HB
Erasmus Medical Center - Centrum
Rotterdam, NL-3075 EA
Erasmus Medical Center Daniel
Rotterdam, NL-3075 EA
Haga Ziekenhuis, loc. Leyenburg
The Hague, NL-2504 LN
Isala Klinieken, Sophia
Zwolle, NL-8000 GK
Belgium12 sites
ZNA Middelheim
Antwerp, 2020
ZNA Stuivenberg
Antwerp, 2020
AZ St Jan
Bruges, 8000
UZ VUB
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
Grand Hôpital de Charleroi
Charleroi, 6000
Hôpital de Jolimont
Haine-St-Paul, 7100
UZ Gasthuisberg
Leuven, 3000
CHR de la Citadelle
Liége, 4000
Clinique St Pierre
Ottignies, 1340
Heilig-Hartziekenhuis
Roeselare, 8800
Clinique de Mont-Godinne
Yvoir, 5530
Denmark6 sites
Aalborg Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8000
Rigshospitalet
Copenhagen, DK-2100
Herlev Hospital
Herlev, DK-2730
Odense University Hospital
Odense, DK-5000
Vejle Hospital
Vejle, DK-7100
Czechia5 sites
University Hospital Brno
Brno, 625 00
University Hospital Olomouc
Olomouc, 775 20
University Hospital Ostrava
Ostrava, 70852
University Hospital Kralovske Vinohrady
Prague, 100 34
University Hospital Motol
Prague, 150 00
Finland5 sites
Helsinki University Central Hospital
Helsinki, 00029
Kuopio University Hospital
Kuopio, 70211
Oulu University Hospital
Oulu, 90029
Tampere University Hospital
Tampere, 33521
Turku University Central Hospital
Turku, 20521
Austria4 sites
AKH Linz
Linz, 4020
Krankenhaus der Elisabethinen
Linz, 4020
Center for Clinical Cancer and Immunology Trials
Salzburg, 5020
Hanusch Krankenhaus
Vienna, 1140
Norway4 sites
Radium Hospital
Oslo, N-0310
Stavanger University Hospital
Stavanger, N-4068
University Hospital of Nothern Norway
Tromsø, N-9038
St. Olavs Hospital
Trondheim, N-7030
Sweden4 sites
Sunderby Hospital
Luleå, S-971 80
Lund University Hospital
Lund, S-221 85
Karolinska University Hospital
Stockholm, S-141 86
Norrlands University Hospital
Umeå, S-901 85
Germany3 sites
Charite Universitätsmedizin Berlin
Berlin, D-13353
Krankenhaus Nordwest
Frankfurt, D-60488
University Hospital Regensburg
Regensburg, D-93042
Poland1 site
Marie Sklodowska-Curie Memorial Institute Cancer Center
Warsaw, 02-781
About this 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
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.
Read the detailed description
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.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab, CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
- Keywords
- Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral, MabCampath, Campath, CHOP-14, CD52 expression
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumabDrug
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-CSFDrug
6 cycles of CHOP every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Not described Receives: Drug: CHOP14 chemotherapy (see specification under Arm B) plus G-CSF |
| Arm B | Experimental | Not described Receives: Drug: CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival
Measured: The EFS is defined by the time between day of randomization until an event occurs, up to 96 months
Secondary outcomes (6)
Overall survival
Measured: From the time of randomisation to date of last follow-up or death, up to 96 months
Overall response rate
Measured: from date of randomization to date of primary response assessment, up to 96 months
Overall response rate related to the CD52 expression
Measured: From date of randomization to date of primary response assessment, up to 96 months
Tumor control or time-to-progression
Measured: 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)
Measured: from randomization to closure of study, up to 96 months
Feasibility of successful stem cell harvest i.e. >/=2E6 CD34 positive cells
Measured: from start of priming regimen to time of assessment of stem cell harvest, up to 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startJun 2008
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark
- Responsible party
- Sponsor
- Investigators
- Francesco d'Amore, Prof, Principal investigator, Dept. of Hematology, Århus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646854
- Sponsor's protocol ID
- 2006-006130-17
- Acronym
- ACT-1
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2008
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00646854
- Acronym / sponsor ID
- ACT-1 / 2006-006130-17
- Conditions
- Lymphoma, T-Cell, Peripheral
- Keywords
- Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral, MabCampath, Campath, CHOP-14, CD52 expression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark
- Study start
- Jun 2008 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumabCyclophosphamide 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 | Drug | Arm B |
| CHOP14 chemotherapy (see specification under Arm B) plus G-CSF6 cycles of CHOP every 2 weeks | Drug | Arm A |
Primary outcome
Event-free Survival
Time frame: The EFS is defined by the time between day of randomization until an event occurs, up to 96 months
6 secondary outcomes
Overall survival
Time frame: From the time of randomisation to date of last follow-up or death, up to 96 months
Overall response rate
Time frame: from date of randomization to date of primary response assessment, up to 96 months
Overall response rate related to the CD52 expression
Time frame: From date of randomization to date of primary response assessment, up to 96 months
Tumor control or time-to-progression
Time frame: 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)
Time frame: from randomization to closure of study, up to 96 months
Feasibility of successful stem cell harvest i.e. >/=2E6 CD34 positive cells
Time frame: from start of priming regimen to time of assessment of stem cell harvest, up to 96 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco d'Amore, Prof principal investigator
Dept. of Hematology, Århus University Hospital, Denmark
59 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab and CHOP14 chemotherapy (see specification under Arm B) plus G-CSF in people with Lymphoma, T-Cell, Peripheral, run by Aarhus University Hospital at 59 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Netherlands, Belgium, Denmark, Czechia, Finland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (time frame: The EFS is defined by the time between day of randomization until an event occurs, up to 96 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.