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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 79 APL / PETHEMA LPA 2005


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

Remission Induction with ATRA + Idarubicin. Risk-adapted consolidation with ATRA and Anthracycline-based Chemotherapy (Idarubicin/Mitoxantrone) with Addition of Ara-C for High-risk Patients. Maintenance Therapy with ATRA + Low Dose Chemotherapy (Methotrexate + Mercaptopurine)


Status

closed



Type of study

Prospective Phase II study


Echelon level

Level B


Current number of patients

90


Date of activation

22-Aug-2006


Approved by

MEC: METC UMCG


Study objectives

Primary objectives
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and survival, as well as on the duration of remission and cumulative incidence of relapse in intermediate-risk patients with APL.
To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for patients (administered as in the original GIMEMA protocols) on the event-free, disease-overall survival, as well as on the duration of remission and cumulative incidence of relapse.
To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy whole series and in each treatment group in patients with APL.

Secondary objectives
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.


2. Patient eligibility criteria



Inclusion criteria

Age 18-75 years
ECOG performance status ? 3.
Morphological diagnosis of APL (FAB-M3 or M3 variant). Those cases without typical morphology but with PML-RARa rearrangement should also be included.
Genetic diagnosis: t(15;17) demonstrated by conventional karyotyping, PML-RARa rearrangement detected by RT-PCR or FISH, microspeckled PML protein pattern demonstrated by PG-M3 monoclonal antibody. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis.


Exclusion criteria

Age >75 years (the treatment with this protocol can be considered on an individual basis)
Absence of PML-RARa rearrangement.
The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxiurea or leukapheresis will not exclude the patient.
Prior chemotherapy or radiotherapy for the treatment of prior malignancy.
Presence of an associated neoplasm.
Presence of a severe psychiatric disease.
HIV seropositivity.
Contraindication for intensive chemotherapy, especially to anthracyclines.
Serum creatinine creatinine ? 250 ?mol/l (? 2.5 mg/dL)
Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit
Positive pregnancy test.


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. B. Löwenberg (Erasmus MC - Centrum)
Prof.Dr. E. Vellenga (UMCG)


Co-Investigator(s)

Dr. M.A. Sanz Alonso (Hospital Universitario La Fe)


Statistician(s)

Dhr. W.L.J. van Putten (Erasmus MC - Daniel)


Trial Manager(s)

Mw. M.C.J. Abrahamse - Testroote (Erasmus MC - Daniel)
Mr.Dr. P. Montesinos (Hospital Universitario La Fe)


Central Data Manager(s)

Mrs. L. Llopis Quiralte (Hospital Universitario La Fe)


Other functions

Central Coordinator - Special Investigations - Mw. R. Verzijl (Erasmus MC - Daniel)


Principal investigator

M. A. Sanz (msanz@uv.es) (Pethema)


Coordinating investigator(s)

E. Vellenga (e.vellenga@int.umcg.nl)
B. Lowenberg (b.lowenberg@erasmusmc.nl)


Statistician(s)

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


Trial manager

L. Benlloch (luisbenlloch@ya.com) (Pethema)


Central data management

L. Benlloch (luisbenlloch@ya.com) (Pethema)
M.C.J. Abrahamse - Testroote(m.testroote@erasmusmc.nl) (HOVON)


Other functions

Statistician:
P. Montesinos (puamonte@hotmail.com) (Pethema)


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
4
NL-Amsterdam-OLVG
4
NL-Amsterdam-VUMC
14
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
7
NL-Enschede-Medisch Spectrum Twente
4
NL-Groningen-UMCG
7
NL-Maastricht-AZ Maastricht
5
NL-Nieuwegein-Antonius Ziekenhuis
8
NL-Rotterdam-Erasmus MC - Daniel
14
NL-Rotterdam-Erasmus MC - Centrum
16
Show 2 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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