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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 71 ALL


News
1. Overview
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


No news


1. Overview



Summary

Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 - 70 years inclusive with chemotherapy including a pre-induction course for rapid tumor load reduction and prolonged maintenance chemotherapy


Status

closed



Type of study

Prospective Phase II study


Target number of patients

55


Current number of patients

60


Date of activation

21-Oct-2005


Date closed

03-Jan-2008


Approved by

CKTO: CKTO 2005-09, 8 September 2005
cMETC: METC UMCG, 22 August 2005, METc 2005/063


2. Patient eligibility criteria



Inclusion criteria

Age 40 - 70 years inclusive;
Primary previously untreated ALL;
WHO performance status 0, 1, or 2 (appendix C);
Negative pregnancy test at inclusion if applicable;
Written informed consent.


Exclusion criteria

Mature B-cell ALL;
Acute undifferentiated leukemia (AUL);
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
Severe pulmonary dysfunction (CTCAE grade III-IV);
Severe neurological or psychiatric disease;
Significant hepatic dysfunction (serum bilirubin or transaminases >=3 times normal level) except when caused by leukemic infiltration;
Significant renal dysfunction (serum creatinin >=3 times normal level after rehydration and correction of hyperuricemia);
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent);
Active, uncontrolled infections;
Patients known to be HIV-positive;
Patient is a lactating woman;
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.


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 name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number (optional)
Sex
Date of birth
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Dr. M. Bellido (UMCG)
Dhr. Dr. S.M.G.J. Daenen (UMCG)
Dhr. Dr. A.W. Dekker (UMCU)
Prof. Dr. R. Willemze (Leids Universitair Medisch Centrum)


Co-Investigator(s)

Prof.dr. J.J. Cornelissen (Erasmus MC - Daniel)


Coordinating Investigator(s)

Prof. dr. J.P. Marie (St. Antoine Hospital)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Trial Manager(s)

Mw. M. Vania (Erasmus MC - Daniel)


Central Data Manager(s)

Mw. M. Vania (Erasmus MC - Daniel)


Other functions

Reviewer - Cytogenetics - Mw. Dr. H.B. Beverloo (Erasmus MC - Medische Faculteit)
Reviewer - HRC - Mw. T. de Jong (Erasmus MC - Daniel)
Reviewer - HRC - Dhr. Dr. M.B. van 't Veer (Erasmus MC - Daniel)


Principal investigator

S.M.G.J. Daenen (s.m.g.j.daenen@int.umcg.nl)


Coordinating investigator(s)

J.J. Cornelissen (j.cornelissen@erasmusmc.nl)
A.W. Dekker (a.w.dekker@azu.nl)
R. Willemze (r.willemze@lumc.nl)
J.P. Marie (jean-pierre.marie@htd.aphp.fr)
B. Labar (boris.labar@inet.hr)


Statistician(s)

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


Trial manager

M. Vania (m.vania.karsomenawi@erasmusmc.nl)


Central data management

M. Vania (m.vania.karsomenawi@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
1
BE-Brugge-Algemeen Ziekenhuis St. Jan
0
BE-Leuven-UZ Gasthuisberg
1
BE-Roeselare-AZDelta
1
NL-Amersfoort-Meander MC
1
NL-Amsterdam-AMC
4
NL-Amsterdam-OLVG
0
NL-Amsterdam-VUMC
3
NL-Arnhem-Ziekenhuis Rijnstate
2
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
1
Show 11 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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