Kurzprotokoll - Kompetenznetz Leukämie

Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
LAM07
Öffentlicher Titel
Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including GO
During Consolidation for AML
Wissenschaftl. Titel
Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk
adapted treatment strategy, including gemtuzumab ozogamicin (GO) during
consolidation, for patients with acute myeloid leukemia (AML).
Kurztitel
LAM07
Studiennummer KN/ELN
LN_NN_2009_381
Studiengruppe
NN
Studienart
einarmig, offen
Studienphase
Phase IV
Erkrankung
Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium
de novo/non-treated
Ziele
-
To provide prognosis stratification of AML patients at the end of the induction
treatment, based on minimal residual disease (MRD), cytogenetics and molecular
findings.
-
To evaluate the efficacy and safety of a post-remission therapy strategy adapted to
the prognosis of the patients, which optimizes the currently available treatment
options and includes GO
-
To analyze the different prognosis factors in AML, including the karyotype and the
molecular findings at diagnosis and the MRD level at the end of the induction.
-
For intensive chemotherapy:
-
Patients with the novo AML or secondary to MDS or previous treatment, regardless of
age.
-
Signed written informed consent.
-
ECOG 2. If ECOG is greater than 2 due to AML, the patient can be included in the
study.
-
LVEF > 40 % measured by means of echocardiography.
-
If background of respiratory disease (not related to the AML), risk factors or clinical
criteria for COPD, the values of functional tests, including DLCO, should be greater
than 50% of the expected.
-
Bilirubin, alkaline phosphatase and ALT < of 3 fold the upper normal value, providing
that it is not due to the disease that motivates the treatment (AML).
-
Serum creatinine < 2,5 mg/dL providing that it is not due to the disease that motivates
the treatment (AML).
-
In fertile aged women, negative pregnancy test and use of contraception methods are
required.
-
Any patient who does not meet the inclusion and exclusion criteria for treatment with
intensive chemotherapy can be evaluated individually when considering that could
still obtain benefit from this treatment considering that could still obtain benefit from
this treatment.
-
Criteria for GO administration in patient candidates for intensive chemotherapy
-
Same criteria for intensive chemotherapy, including the following specifications:
-
CD33 positive (more than 5 % of the leukemic population)
-
Exclusion for treatment with GO in cases of serious hepatic disease not due to AML.
-
In patients who are going to receive GO in two cycles, the second one will be only
administrated if the toxicity due to the first cycle is recovered.
Einschlusskriterien
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Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
LAM07
Ausschlusskriterien
-
Though the GO administered dose is much lower than usual, it is recommended a
period of two months between GO administration and hematopoietic stem cell
transplantation (HSCT).
-
Criteria for the modification of high dose ARA-C
-
The dose of Ara-C in cycles containing HiDAC should be reduced in the following
cases:
-
The hematopoietic recovery in the previous cycle has been longer than 28 days.
-
Presence in the previous cycles of a confluent maculopapular rash or drug-induced
shedding.
-
More than 4 episodes of watery diarrhea per day.
-
Increase of 4 fold the previous normal value of aminotransferases or alkaline
phosphatase in any of the cycles.
-
Total bilirubin greater than 3 mg/dL in any of the cycles.
-
Treatment with HiDAC will be definitively suspended (even that included in the BEA
conditioning) when previous toxicity include severe cerebellar ataxia, confusion or
another sign of central nervous toxicity that has not another clear explanation.
-
Patients with blastic crisis of a chronic myeloid leukemia or other myeloproliferative
syndromes evolving to acute leukemia.
-
Patients with AML in relapse.
-
Acute promyelocytic leukemia (M3 or M3v).
-
Absence of signed written informed consent.
-
ECOG 3 that it is not due to the disease that motivates the treatment (AML).
-
LVEF < 40 % determined by echocardiography study.
-
Values of respiratory functional tests, including DLCO, lower than 50% of the
expected.
-
Bilirubin, alkaline phosphatase or GOT > 3 fold the upper normal value, providing that
it is not due to the disease that motivates the treatment (AML).
-
Serum creatinine > of 2.5 mg/dL providing that it is not due to the disease that
motivates the treatment (AML).
-
Positive pregnancy test or not use of effective contraception in fertile aged women.
-
Previous treatment with antileukemic chemotherapy, except hydroxyurea.
-
Presence of an active neoplasia different from the AML.
-
Presence of a serious psychiatric disease.
-
Positive HIV test.
-
Any other condition which limits or dissuades from the treatment with intensive
chemotherapy, especially with anthracyclines
Alter
keine Angabe
Status
Rekrutierung beendet
Beginn der Rekrutierung
28.12.2009
Rekrutierende Länder
Spanien
Studienleiter/in
Angel, Dr, Sanz Miguel
E-Mail: [email protected]
Förderer
PETHEMA Foundation
Registrierung in anderen
Studienregistern
ClinicalTrials.govNCT01041040 (primäres Register)
Anmerkung
contacts see: http://clinicaltrials.gov/ct2/show/NCT01041040
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 13.01.2017; Seite 2 von 2