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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 91 T-NHL (ACT-2)


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO91 news

The HO91 T-NHL ACT 2 study has re-opened for inclusion of patients as of 29-SEP-2010.

 

The HO91 T-NHL study has been 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 DSHNHL (Prof Dr L Truemper)

 

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.


1. Overview



Summary

A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, oxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma


Status

closed


Members

Leading group: DSHNHL (German High-Grade Non-Hodgkin's Lymphoma Study Group), Prof Dr L Truemper



Study details



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Study specific


Target number of patients

274


Approved by

METC UMC Groningen: 25-NOV-2008
AM1: 12-APR-2010
AM2: 29-SEP-2010


Study objectives

Primary objective:
Improvement of the efficacy of chemotherapy with CHOP-14 by the additional use of the CD52 monoclonal antibody alemtuzumab measured on the basis of Event-free Survival.


2. Patient eligibility criteria



Inclusion criteria

1. Age: 61 - 80 years
2. Risk group: All risk groups, including stage I with bulk (≥ 7.5 cm) and stages II to IV, except stage I N without bulk and with no IPI risk factor besides the age over 60
3. Histology: Diagnosis of aggressive non-Hodgkin's lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat all peripheral T-lineage lymphomas with the exception of ALKpositive anaplastic large cell lymphoma and primary cutaneous T-cell lymphomas (Mycosis fungoides, Sezary syndrome and primary cutaneous CD30-positive lymphoproliferations, and transformed primary cutaneous T-cell lymphomas). These
lymphomas comprise:
T cell -NHL:
peripheral T-cell lymphoma PTCL-NOS
Lennert's lymphoma
T-zone lymphoma
T-immunoblastic variant
Perifollicular/follicular variant
T-cell lymphoma of the AIL type
extranodal NK/T-cell lymphoma, nasal type
intestinal T/NK-cell lymphoma (± enteropathy)
hepatosplenic gamma-delta lymphoma
subcutaneous panniculitis-like PTCL
4. Performance status: Performance status ECOG 0 - 2 (Karnofsky index: 60 -100%). The general status of each patient is to be assessed at
time of randomisation and can thus take place after initiation of prephase treatment. A performance status of ECOG 3 will
allow inclusion, if it is lymphoma related. The pretreatment status is to be documented in the staging CRF; the performance after the prephase treatment is also to be documented in the relevant CRF for the prephase treatment (see Appendix). A definition of the performance status is provided in the Appendix.
5. Declaration of center participation
6. written consent of the patient
7. measurable disease defined as at least one lesion with two measurable perpendicular
diameters of which at least one should be >=15 mm


Exclusion criteria

1. Stage I N with IPI 0 except age > 60 and without bulk
2. Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
3. Serious accompanying disorder or impaired organ function, in particular:
Cardiac: angina pectoris CCS >2, cardiac failure NYHA >2 and/or EF <45% or FS<25% in echocardiography/nuclear medicine examination
Pulmonary: abnormal blood gases; 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
Renal: creatinine >2 times the upper reference limit, unless related to NHL
Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
4. Platelets <100 000/mm3, leukocytes <2500/mm3
5. Bone marrow involvement >25%
6. Primary leukemic manifestation of the lymphoma
7. Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
8. Known HIV-positivity
9. Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
10. Suspicion that patient compliance will be poor
11. Simultaneous participation in any other study protocol
12. Prior chemo- or radiotherapy for malignancy
13. Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)


3. Registration (& randomization) of patients



Registration

Central registration at the Trial Office Gottingen:
Elke Stitz
Fax number.....: +49-551/39-22180


Registration criteria

The following information will be requested:



Please note that registration should be performed by the Trial Office in Gottingen

The following information is required for randomisation:
name of institution and treating physician
name of pathologist
name of the radiologist, if radiotherapy is planned
identification of the patient
age
sex
histopathologic subtype (WHO classification) from primary pathologist and confirmation
from referral pathologist
confirmation that patient conforms to eligibility criteria
confirmation that no exclusion criteria apply
IPI criteria: * LDH and upper normal limit of LDH in the respective laboratory
* performance status ECOG score (Karnofsky index)
* Ann Arbor stage
* presence of extranodal involvement (number, site)
presence of bulky disease (site)
sites of lymphoma involvement
haematological status.


4. Participating parties



Principal investigator

Prof Dr L Truemper (University Hospital of the Georg-August University, Gottingen, Germany)

Prof Dr F d'Amore (Aarhus University Hospital, Aarhus, Denmark), European Intergroup Principal Investigator


Coordinating investigator(s)

For the Netherlands: Prof Dr JC Kluin-Nelemans


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

S.Cunha (s.cunha@erasmusmc.nl)


Central data management

IMISE, University of Leipzig, Germany
(CRFs and query answers should be sent to the Trial Offices in Gottingen. They will forward the CRFs and query answers to IMISE)


Other functions

Central review pathologist:
Dr. Arjan Diepstra
UMCG
Department of Pathology
P.O. Box 30001
NL – 9700 RB Groningen

e-mail: a.diepstra@path.umcg.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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