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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 37 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

Early Intensification by (un)related Allogenic or Autologous Stem Cell Transplantation in Adult Acute Lymphoblastic Leukemia: A Phase II Study.


Status

closed



Type of study

Prospective Phase II study


Target number of patients

200


Date of activation

15-Apr-1999


Date closed

25-Nov-2005


Approved by

CKVO Status: January 1999 Approved
CKVO 98-03


2. Patient eligibility criteria



Inclusion criteria

Age between 16 and 59 (inclusive) years.
Previously untreated with chemotherapy.
ALL according to the FAB criteria and immunological marker analysis (B-precursor ALL, T-ALL and AUL)
WHO performance status grade 0, 1, 2 or 3.
Patient informed consent.

Patients will be randomised for maintenance chemotherapy one week prior to the start of the conditioning regimen of autologous SCT, after informed consent has been obtained for either no therapy or maintenance therapy for one year.

Criteria for Start of Maintenance Therapy
CR after autologous SCT.
Hematological recovery.
a. leukocytes > 3 x 109/l.
b. platelets > 80 x 109/l.
WHO performance status 0, 1, 2.


Exclusion criteria

B-ALL
Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease.
Second malignant disease, except cervix carcinoma stage 1 and non-melanoma skin cancer.
Persisting renal insufficiency.
Active uncontrolled infections.
HIV positivity.

Exclusion Criteria for Start of Maintenance Therapy
Severe toxicity CTC grade > 1.
No BM-recovery after 3 months.
Previous allergic lung reaction to MTX.


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


4. Participating parties



Principal Investigator(s)

Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)
Dhr. Dr. A.W. Dekker (UMCU)


Statistician(s)

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


Other functions

Central Coordinator - Molecular Diagnostics - Mw. Dr. M. Jongen-Lavrencic (Erasmus MC - Daniel)
Central Coordinator - Molecular Diagnostics - Dhr. Dr. M.B. van 't Veer (Erasmus MC - Daniel)
Reviewer - Cytogenetics - Mw. Dr. E. van den Berg (UMCG)
Reviewer - Cytogenetics - Mw. Dr. H.B. Beverloo (Erasmus MC - Medische Faculteit)
Reviewer - Cytogenetics - Mw. W.G. Kroes (KGCL)
Reviewer - HRC - Mw. T. de Jong (Erasmus MC - Daniel)


Principal investigator

AW Dekker (a.w.dekker@digd.azu.nl)


Coordinating investigator(s)

JJ Cornelissen (cornelissen@hemh.azr.nl)


Statistician(s)

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


Central data management

J. van Tuijn (j.vantuijn@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
38
NL-Amersfoort-Meander MC
7
NL-Amsterdam-AMC
30
NL-Amsterdam-Antoni van Leeuwenhoek ZH
0
NL-Amsterdam-VUMC
27
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
13
NL-Enschede-Medisch Spectrum Twente
6
NL-Heerlen-Atrium MC loc. Heerlen
2
NL-Maastricht-AZ Maastricht
22
NL-Nieuwegein-Antonius Ziekenhuis
8
Show 5 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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