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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 39 NHL / EORTC 20981


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


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1. Overview



Summary

Chimeric Anti-CD20 Monoclonal Antibody (Mabthera®) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin’s Lymphoma: A Phase III Randomised Clinical Trial – Intergroup Collaborative Study (EORTC 20981).


Status

closed


Members

Hovon 39 is an Intergroup Study, with the following groups participating:
EORTC;
Protocol Chairman: MHJ van Oers, A Hagenbeek
Biostatistician: M van Glabbeke
Medical Supervisor: I Theodorovic
Australian New Zealand Lymphoma Group;
M. Wolf
BNLI(UK);
RE Marcus
GELA(France,Belgium);
B Coiffier
GOTEL(Spain);
EJ Gomez Codina
HOVON;
MHJ van Oers, A Hagenbeek, WLJ van Putten
Italian Group;
AM Gianni
NCIC CTG Hematology Group(Canada);
R Klasa
Nordic Lymphoma Group;
E Kimby
SAKK(Switzerland);
T Cerny



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

600


Date of activation

19-Jan-1999


Approved by

EORTC-PRC Approval 17.08.1998


2. Patient eligibility criteria



Inclusion criteria

Follicular NHL according to the REAL classification.
Patients with Ann Arbor stages III or IV follicular NHL who have relapsed after a maximum of two adequate non-anthracycline containing systemic chemotherapy regimens.
Patients with either remission (CR, PR), no change or progression on one of a maximum of 2 prior regiments.
To qualify for remission or NC, duration of response c.q. NC upon one of the prior regimens should have been at least 4 weeks.
Previous treatment should have been at least 2 months of single agent therapy and / or at least 2 consecutive cycles of polychemotherapy or purine analogues.
The lymphoma must be CD20 positive.
At least one mass should be present measurable by 2 perpendicular diameters by either physical or radiological examination.
Age : 18 years or older.
WHO Performance Status 0, 1 or 2.
Patient information and written informed consent according to the rules of the respective country c.q institute.

Eligibility criteria for second randomisation:
Patients in complete or partial remission at least 4 weeks after the last of 6 cycles of CHOP ± Mabthera.
Patients in complete or partial remission at least 4 weeks after the last of at least 3 cycles of CHOP ± Mabthera, if this treatment had to be stopped because of CHOP-related adverse event.
For patients treated with CHOP + Mabthera® during remission induction: no Mabthera-related adverse event necessitating stopping of Mabthera® administration.
Time interval since last cycle of CHOP ± Mabthera® between 4 and 8 weeks.
IgG levels >= 3 gr/l.
No active infection.
Written informed consent.


Exclusion criteria

Prior treatment with more than two adequate regimens of systemic chemotherapy, or prior treatment with inadequate systemic chemotherapy.
Prior treatment with anthracyclines / Mitoxantrone.
Prior treatment with Mabthera®.
Circulating tumor cells > 10x109/l.
Low grade lymphoma transformed into intermediate / high grade lymphoma.
Patients with severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease.
Serum creatinine, BUN, alkaline phosphatase or bilirubin: > 2.5 times the upper limit of the normal value, unless clearly related to NHL.
Pregnant women.
Patients with prior malignancies except non-melanoma skin tumors, stage 0 cervical carcinoma or curative surgical therapy longer than 5 years ago.
Patients with known HIV positivity.
Patients with symptomatic CNS lymphoma.
Patients with bone marrow involvement only.
Patients with uncontrolled asthma or allergy, requiring steroid treatment.
Patients who are unable to attend regular outpatient appointments for treatment and treatment evaluation.
Patients with IgG levels < 3 gr/l.
Prior allogenic or autologous stem cell transplantation.
Patients considered in near future for peripheral blood stem cell collection using chemotherapy for mobilisation.
Patients known to have any hypersensitivity or anaphylactic reactions to murine proteins or to any component of this product


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution's name/number
Name of investigator and location of trial centre
Patient's identification: - initials - date of birth - sex - optional: hospital record number
Checklist of inclusion/exclusion criteria
Projected date of treatment start
Information relevant for stratification

For the second randomisation the following information is required:
Protocol number
Institution's name/number
Name of investigator and location of trial centre
Patient's identification - unique study number - initials - date of birth - sex - optional: hospital record number
Date of last cycle of CHOP c.q CHOP+ Mabthera®
Response to CHOP c.q CHOP+ Mabthera®
Checklist of in/exclusion criteria for second randomisation


4. Participating parties



Principal investigator

MHJ van Oers(M.H.vanOers@AMC.UVA.nl)


Coordinating investigator(s)

A Hagenbeek (a.hagenbeek@lab.azu.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Central data management

EORTC Datamanagement:
C Rozewicz (cro@eortc.be)
HOVON Datamanagement:
M Steijaert (m.steijaert@erasmusmc.nl)


Other functions

EORTC Statistician:
M van Glabbeke
Central Pathologist for EORTC and HOVON:
C de Wolf-Peeters


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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