HOVON HO90 NHL

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Main info

Identificatie:
HO90 NHL
Sponsor:
HOVON
Working group party:
Lymphoma
Age:
18-60
Stadium:
1st lijn
Active sites:
29
(of 29)
Title:

ACT-1 (younger patients) 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 Tcell lymphomas

Timeline

Scheduled
Actual
2009
22 apr.
EC Approval
2009
22 apr.
First Site
2019
11 jan.
Opportunity
2020
14 mei
Closeout in Progress
2021
01 apr.
Archived

News

  • Both amendment 1 & 2 have been approved for the HO90 T-NHL (ACT1) study.
  • After receipt of the protocol signature pages, adjusted ICF and signed checklist at the HOVON Data Center, patients can be included again.
  • The HO90 T-NHL study has been initial approved by the METC of the UMC Groningen on 25-NOV-2008.
  • This study is a so-called intergroup study in which HOVON participates. Leading group is the Nordic Lymphoma Group (Prof F. d'Amore). If you wish to participate in this study please contact the HOVON Data Center (M. Luten), before taking any action.
  • Please notice that a FAQ document is available for this study. If you have any other question regarding this study, do not hesitate to contact the HOVON Data Center.

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Not any more
Objectives:

Primary objective:
To assess the effect of the addition of alemtuzumab s.c. to 6 courses of 2-weekly CHOP14 in terms of Event-Free Survival (EFS) as defined in paragraph 16.1.

Secondary Objectives:

  • To assess the effect of the addition of alemtuzumab s.c. to 6 courses of 2-weekly CHOP14 in term of overall survival (OS), progression-free survival (PFS) and overall response rates (ORR, i.e. CR/CRu/PR), tumor control or time to progression (TTP).

Assessment of ORR means evaluating eligibility to autologous stem cell transplantation.

  • To assess the overall response rates (ORR) related to the CD52 expression.
  • To evaluate the safety of the addition of alemtuzumab s.c. combined with 2-weekly CHOP with respect to the incidence of severe opportunistic infections and infections due to neutropenia as well as the adherence to protocol as defined in paragraph 16.2.

Eligibility

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 (Appendix C):
    • Peripheral T-cell lymphoma, unspecified (PTCL NOS)
    • Angioimmunoblastic T-cell lymphoma
    • Enteropathy associated T cell lymphoma
    • Subcutaneous panniculitis-like T-NHL (gd 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 (see appendix D). 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 anticonception (contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices and transdermal patches are

considered as safe contraceptive methods).

Registration Details

The patient should be registered and randomized immediately after satisfactory completion of screening tests and obtaining informed consent, and before the start of chemotherapy. Patients need to be registered at the Clinical Trial Office.
The following information will be requested at randomization:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Patient’s initials or code
  • Patient’s hospital record number
  • Sex
  • Date of birth
  • Date of diagnosis of NHL
  • WHO classification
  • Pathology result from referral/reference pathologist
  • Eligibility criteria (i.e. all inclusion and exclusion criteria)

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
29 results
Order by
Accrual rate
Activation date
BE-Brugge-AZBRUGGE
01 nov. 2012
NL-Enschede-MST
11 jan. 2010
NL-Amsterdam-OLVG
NL-Nijmegen-RADBOUDUMC
22 sep. 2009
NL-Nieuwegein-ANTONIUS
07 mei 2009
NL-Groningen-UMCG
05 mei 2009
NL-Amsterdam-VUMC
22 sep. 2009
NL-Dordrecht-ASZ
28 mei 2009
BE-Yvoir-MONTGODINNE
22 dec. 2010
BE-Haine-Saint-Paul-JOLIMONT
01 nov. 2012
BE-Brussel-UZBRUSSEL
01 nov. 2012
BE-Brussel-ERASME
BE-Charleroi-GHDC
01 nov. 2012
NL-Amersfoort-MEANDERMC
13 jan. 2010
NL-Maastricht-MUMC
26 jan. 2010
NL-Leiden-LUMC
14 mei 2009
BE-Roeselare-AZDELTA
01 nov. 2012
BE-Bruxelles-STLUC
22 dec. 2010
BE-Liege-CHRCITADELLE
BE-Leuven-UZLEUVEN
01 nov. 2012
BE-Gent-UZGENT
BE-Antwerpen-ZNAMIDDELHEIM
01 nov. 2012
BE-Antwerpen-ZNASTUIVENBERG
01 nov. 2012
NL-Amsterdam-AMC
21 apr. 2009
NL-Rotterdam-EMCDANIEL
22 sep. 2009
NL-Rotterdam-ERASMUSMC
19 aug. 2009
NL-Den Haag-HAGA
22 sep. 2009
NL-Zwolle-ISALA
21 apr. 2009
BE-Ottignies-CSPO
22 dec. 2010
= Active hospitals
= Inactive hospitals

Participating Parties

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