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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 74 ALL


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

Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse
A randomized phase II study


Status

closed



Study details



Type of study

Prospective randomized Phase II study


Target number of patients

120


Date of activation

11-May-2006


Date closed

19-Oct-2007


Approved by

CKTO 2005-18, 15 March 2006
METc LUMC P05.141, 10 January 2006


2. Patient eligibility criteria



Inclusion criteria

Age 18 - 70 years inclusive
First or second relapse of precursor B-ALL or T-ALL (including Philadelphia chromosome or BCR-ABL positive ALL)
Duration of last complete remission at least 6 months
WHO performance status 0, 1, or 2
Negative pregnancy test at inclusion if applicable
Written informed consent


Exclusion criteria

Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
Acute undifferentiated leukemia (AUL)
Treatment with alemtuzumab at any time prior to registration
Intolerance of exogenous protein administration
Central nervous system (CNS) leukemia (appendix A)
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)
Significant renal dysfunction (serum creatinin >= 3 times normal level)
Patients with active, uncontrolled infections
Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration
Patients known to be HIV-positive
Patient is a lactating woman
Any psychological, familial, sociological or 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
First or second relapse
Duration of last remission
Eligibility criteria


4. Participating parties



Principal investigator

R. Willemze (r.willemze@lumc.nl)


Coordinating investigator(s)

J.P. Marie (jean-pierre.marie@htd.aphp.fr)
B. Labar (boris.labar@inet.hr)
J.J. Cornelissen (j.cornelissen@erasmusmc.nl)
A.W. Dekker (a.w.dekker@azu.nl)
S. Amadori (mc7673@mclink.it)


Statistician(s)

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


Trial manager

F. Spoelstra (f.spoelstra@erasmusmc.nl)


Central data management

F. Spoelstra (f.spoelstra@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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