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

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ClinicalTrials.gov Identifier: NCT00646854
Recruitment Status : Unknown
Verified November 2012 by University of Aarhus ( Aarhus University Hospital ).
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2008
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2008
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Alemtuzumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm A Drug: CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
6 cycles of CHOP every 2 weeks
Experimental: Arm B 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

Outcome Measures

Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: The EFS is defined by the time between day of randomization until an event occurs, up to 96 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the time of randomisation to date of last follow-up or death, up to 96 months ]
  2. Overall response rate [ Time Frame: from date of randomization to date of primary response assessment, up to 96 months ]
  3. Overall response rate related to the CD52 expression [ Time Frame: From date of randomization to date of primary response assessment, up to 96 months ]
  4. Tumor control or time-to-progression [ Time Frame: time of randomization to last follow-up or time of disease progression, up to 96 months ]
  5. 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 ]
  6. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646854

  Show 59 Study Locations
Sponsors and Collaborators
Aarhus University Hospital
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Principal Investigator: Francesco d'Amore, Prof Dept. of Hematology, Århus University Hospital, Denmark
More Information

Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00646854     History of Changes
Other Study ID Numbers: 2006-006130-17
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: November 2012

Keywords provided by University of Aarhus ( Aarhus University Hospital ):
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
CD52 expression

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors