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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 70 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


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1. Overview



Summary

Feasibility study using repeated intensive chemotherapy coursesfor patients with primary acute lymphoblastic leukemia in adults age 18 - 39 years inclusive


Status

closed



Type of study

Prospective Phase II study


Target number of patients

55


Current number of patients

54


Date of activation

21-Oct-2005


Date closed

28-Aug-2007


Approved by

CKTO 2005-08, October 10, 2005
METc UMCG 2005.062, August 15, 2005


2. Patient eligibility criteria



Inclusion criteria

Age 18 - 39 years inclusive;
Primary previously untreated ALL (including Philadelphia chromosome or BCR-ABL positive 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;
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
Severe neurological or psychiatric disease;
Significant hepatic dysfunction (serum bilirubin or transaminases >=3 times normal level);
Significant renal dysfunction (serum creatinine >= 3 times normal level);
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
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)

Prof.dr. J.J. Cornelissen (Erasmus MC - Daniel)
Dhr. Dr. A.W. Dekker (UMCU)
Prof. Dr. R. Willemze (Leids Universitair Medisch Centrum)


Co-Investigator(s)

Dhr. Dr. S.M.G.J. Daenen (UMCG)


Coordinating Investigator(s)

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


Statistician(s)

Dhr. Dr. B. van der Holt (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

J. Cornelissen (j.cornelissen@erasmusmc.nl)


Coordinating investigator(s)

J.P. Marie (jean-pierre.marie@htd.aphp.fr)
J.J. Cornelissen (j.cornelissen@erasmusmc.nl)
A.W. Dekker (a.w.dekker@azu.nl)
S.M.G.J. Daenen (s.m.g.j.daenen@int.umcg.nl)
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
0
BE-Brugge-Algemeen Ziekenhuis St. Jan
0
BE-Leuven-UZ Gasthuisberg
2
BE-Roeselare-AZDelta
1
NL-Amersfoort-Meander MC
1
NL-Amsterdam-AMC
9
NL-Amsterdam-VUMC
9
NL-Arnhem-Ziekenhuis Rijnstate
2
NL-Den Bosch-Jeroen Bosch ziekenhuis
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
1
Show 10 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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