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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 18 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

Autologous Bone Marrow Transplantation with a Radiation-free Preparatory Regimen (Bu/Cy) in adult patients with ALL in the first remission after Conventional Induction and Intensification Chemotherapy: A Phase II Study.


Status

closed



Type of study

Prospective Phase II study


Date of activation

15-Jun-1993


Date closed

05-Apr-1999


Approved by

CKVO 92-10


2. Patient eligibility criteria



Inclusion criteria

Age between 16 and 60 years.
Previously untreated.
All according to the FAB criteria.
AUL according to immunological marker analysis.
Patients must have persistant serum creatinine < 200 µmol/l.
Patients must have serum direct bilirubin < 65 µmol/l.
WHO performance status grade 0, 1, 2 or 3.
Absence of other severe disease.


Exclusion criteria

Performance status grade 4 according to the WHO classification.
Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease.
Second primary malignant disease, except cervix carcinoma and non-melanoma skin cancer.
Persisting renal insufficiency.
Patients previously treated with chemotherapy.
Active uncontrolled infections.
HIV positivity on serological tests.


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
Patient’s namecode
Date of birth
Hospital record number
Name of responsible investigator
Date of start treatment


4. Participating parties



Principal investigator

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


Coordinating investigator(s)

W Sizoo


Statistician(s)

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


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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