natgillin/translations-raw huggingface dataset:
WBC < 10 x 109/ l, platelet < 450 x 109/ l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1– 35%), minor (36– 65%) or minimal (66– 95%).
15 promielocitov v krvi, bazofilci < 20%, brez ekstramedularne prizadetosti Kriteriji citogenetičnega odziva: popolni (0% Ph+ metafaz), delni (1– 35%), manjši (36– 65%) ali minimalni (66– 95%).
A major response (0– 35%) combines both complete and partial responses.
Pomemben odziv (0– 35%) združuje popolni in delni odziv.
Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
Kriteriji pomembnega molekularnega odziva: zmanjšanje količine Bcr- Abl transkriptov v periferni krvi za ≥ 3 logaritme (merjeno s kvantitativno PCR določitvijo reverzne transkriptaze v realnem času) glede na standardizirane izhodiščne vrednosti.
Rates of complete haematological response, major cytogenetic response and complete cytogenetic response on first-line treatment were estimated using the Kaplan-Meier approach, for which non- responses were censored at the date of last examination.
Stopnje popolnega hematološkega odziva, pomembnega citogenetičnega odziva in popolnega citogenetičnega odziva pri zdravljenju z zdravilom prvega izbora so ocenili po Kaplan- Meierjevi metodi, za katero so izide ne- odzivnosti določili na datum zadnjega pregleda.
CHR from 96.4% to 98.4% and CCyR from 69.5% to 86.7%, respectively.
Na ta način pridobljene ocene kumulativnih stopenj odziva za zdravljenje z zdravilom Glivec kot zdravilom prvega izbora so med 12. in 60. mesecem zdravljenja pokazale izboljšanje in sicer: popolni hematološki odziv s 96, 4% na 98, 4% in popolni citogeneteični odziv z 69, 5% na 86, 7%.
With 5 years follow-up, there were 86 (15.6%) progression events in the Glivec arm:
Po 5 letih spremljanja je bilo v kraku z zdravilom Glivec 86 (15, 6%) dogodkov, ki pomenijo napredovanje bolezni:
35 (6.3%) involving progression to accelerated phase/ blast crisis, 28 (5.1%) loss of MCyR, 14 (2.5%) loss of CHR or increase in WBC, and 9 (1.6%) CML unrelated deaths.
35 (6, 3%) jih je vključevalo napredovanje v pospešeno fazo/ blastno krizo, 28 (5, 1%) izgubo pomembnega citogenetičnega odziva, 14 (2, 5%) izgubo popolnega hematološkega odziva ali zvišanje WBC, 9 (1, 6%) pa je bilo smrti brez povezave s CML.
In contrast, there were 155 (28.0%) events in the IFN+Ara-C arm, of which 128 occurred during first-line treatment with IFN+Ara-C.
Za razliko od tega je bilo v kraku z IFN+Ara- C 155 (28, 0%) dogodkov, od tega se jih je 128 zgodilo v času zdravljenja z IFN+Ara- C kot zdravilom prvega izbora.
The estimated rate of patients free of progression to accelerated phase or blast crisis at 60 months was significantly higher in the Glivec arm compared to the IFN arm (92.9% versus 86.2%, p < 0.001).
Ocenjeni odstotek bolnikov, ki niso napredovali v pospešeno fazo ali blastno krizo pri 60 mesecih, je bil bistveno večji na kraku z zdravilom Glivec v primerjavi s krakom z IFN (92, 9% proti 86, 2%, p < 0, 001).
The annual rate of progression to accelerated phase or blast crisis decreased with time on therapy and was less than 1% annually in the fourth and fifth years.
Letna stopnja napredovanja v pospešeno fazo ali blastno krizo je upadala s trajanjem zdravljenja in je bila v četrtem in petem letu manj kot 1% letno.
The estimated rate of progression-free survival at 60 months was 83.2% in the Glivec arm and 64.1% in the control arm (p < 0.001).
Ocenjeni delež preživelih brez napredovanja bolezni pri 60 mesecih je bil 83, 2% na kraku z zdravilo Glivec in 64, 1% na kontrolnem kraku (p < 0, 001).
A total of 57 (10.3%) and 73 (13.2%) patients died in the Glivec and IFN+Ara-C groups, respectively.
Skupno je umrlo 57 (10, 3%) bolnikov iz skupine z zdravilom Glivec in 73 (13, 2%) iz skupine z IFN+Ara- C.
85.6% (82, 89) in the randomised Glivec and the IFN+Ara-C groups, respectively (p=0.049, log-rank test).
Po 60 mesecih je ocenjeno celotno preživetje v skupini randomizirani na zdravilo Glivec 89, 4% (86, 92) v primerjavi z 85, 6% (82, 89) v skupini randomizirani na IFN+Ara- C (p=0, 049, test log- rank).
This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Glivec.
Na ta opazovani dogodek, ki se veže na čas do dogodka, je močno vplival velik delež bolnikov, ki so z zdravljenja z IFN+Ara- C prešli na zdravilo Glivec.
The effect of Glivec treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Glivec data with the primary data from another Phase III
Vpliv zdravljenja z zdravilom Glivec na preživetje v kronični fazi pri novo diagnosticirani CML so nadalje preiskovali z retrospektivno analizo zgoraj opisanih podatkov o zdravilu Glivec skupaj s prvotnimi podatki druge študije faze III, v kateri so uporabljali IFN+Ara- C s povsem enakim režimom zdravljenja (n=325).
In this retrospective analysis, the superiority of Glivec over IFN+Ara-C in overall survival was demonstrated (p < 0.001); within 42 months, 47 (8.5%) Glivec patients and 63 (19.4%) IFN+Ara-C patients had died.
V tej retrospektivni analizi se je z vidika celotnega preživetja zdravilo Glivec izkazalo za boljše od IFN+Ara- C (p < 0, 001): v 42 mesecih je umrlo 47 (8, 5%) bolnikov z zdravilom Glivec in 63 (19, 4%) bolnikov z IFN+Ara- C.
Whereas an estimated 97% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/ blast crisis at 60 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 60 months (p < 0.001 overall, p=0.20 between CCyR and PCyR).
Za razliko od bolnikov s popolnim oziroma delnim citogenetičnim odzivom pri 12 mesecih, od katerih pri 97% (za popolni odziv) oziroma 93% (za delni odziv) ni prišlo do napredovanja bolezni v pospešeno fazo/ blastno krizo po 60 mesecih, pa od bolnikov, ki so bili pri 12 mesecih brez pomembnega citogentičnega odziva, le pri 81% ni prišlo do napredovanja bolezni v napredovalo fazo CML po 60 mesecih (p < 0, 001 skupno, p=0, 20 med popolnim in delnim citogenetičnim odzivom).
For patients with CCyR and reduction in Bcr-Abl transcripts of at least 3 logarithms at 12 months, the probability of remaining free from progression to accelerated phase/ blast crisis was 100% at 60 months.
Pri bolnikih s popolnim citogenetičnim odzivom in z zmanjšanjem števila transkriptov Bcr- Abl za vsaj 3 logaritme pri 12 mesecih je bila verjetnost, da bolezen ne napreduje v pospešeno fazo/ blastno krizo, po 60 mesecih 100%.
In this study, dose escalations were allowed from 400 mg daily to 600 mg daily, then from 600 mg daily to 800 mg daily.
V tej študiji so bila dovoljena zvišanja odmerka s 400 mg na dan na 600 mg na dan, nato s 600 mg na dan na 800 mg na dan.
Of these 11 patients, 4 patients escalated up to 800 mg daily, 2 of whom regained a cytogenetic response (1 partial and 1 complete, the latter also achieving a molecular response), while of the 7 patients who did not escalate the dose, only one regained a complete cytogenetic response.
Od teh 11 bolnikov so 4 bolnikom zvečali odmerek na 800 mg na dan, od njih sta 2 spet dobila citogenetični odziv (1 delnega in 1 popolnega, le- ta je dosegel tudi molekularni odziv), medtem ko je od 7 bolnikov, pri katerih odmerka niso zvečali, le eden spet dobil popolni
The more frequent adverse reactions included gastrointestinal haemorrhages, conjunctivitis and elevation of transaminases or bilirubin.
Med pogostejšimi neželenimi reakcijami so bili gastrointestinalne krvavitve, konjunktivitis in zvišanje transaminaz ali bilirubina.
Chronic phase, Interferon failure:
Kronična faza, neuspeh z interferonom:
532 adult patients were treated at a starting dose of 400 mg.
532 odraslih bolnikov so zdravili z začetnim odmerkom 400 mg.
The patients were distributed in three main categories: haematological failure (29%), cytogenetic failure (35%), or intolerance to interferon (36%).
Bolniki so bili razdeljeni v tri glavne kategorije: hematološki neuspeh (29%), citogenetični neuspeh (35%) ali neprenašanje interferona (36%).
Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/ week and were all in late chronic phase, with a median time from diagnosis of 32 months.
Povprečno trajanje predhodnega zdravljenja z IFN z odmerki ≥ 25 x 106 i. e. / teden je bilo 14 mesecev, bolniki pa so bili vsi v pozni kronični fazi s povprečnim časom 32 mesecev od postavitve diagnoze.
The primary efficacy variable of the study was the rate of major cytogenetic response (complete plus partial response, 0 to 35% Ph+ metaphases in the bone marrow).
Primarna učinkovitostna spremenljivka študije je bila stopnja pomembnega citogenetičnega odziva (popolni plus delni odziv, 0 do 35% Ph+ metafaz v kostnem mozgu).
In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 4).
V tej študiji je 65% bolnikov doseglo pomemben citogenetični odziv, ki je bil popoln pri 53% (potrjen pri 43%) bolnikov (preglednica 4).
A complete haematological response was achieved in 95% of patients.
Popoln hematološki odziv je bil dosežen pri 95% bolnikov.
Accelerated phase:
Pospešena faza:
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i. e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega kot popolni hematološki odziv, kot odsotnost vseh znakov levkemije (tj., izginotje blastov iz kostnega mozga in krvi, a brez popolnega okrevanja periferne krvi kot pri popolnem odzivu), ali kot vrnitev v kronično fazo CML.
A confirmed haematological response was achieved in 71.5% of patients (Table 4).
Potrjeni hematološki odziv je bil dosežen pri 71, 5% bolnikov (preglednica 4).
Importantly, 27.7% of patients also achieved a major cytogenetic response, which was complete in 20.4% (confirmed 16%) of patients.
Pri tem je pomembno, da je 27, 7% bolnikov doseglo tudi pomemben citogenetični odziv, ki je bil pri 20, 4% bolnikov popoln (potrjen pri 16%).
For the patients treated at 600 mg, the current estimates for median progression-free-survival and overall survival were 22.9 and 42.5 months, respectively.
Za bolnike, zdravljene s 600 mg, je trenutna ocena medianega preživetja brez napredovanja bolezni in preživetja nasploh 22, 9 oziroma 42, 5 meseca.
Myeloid blast crisis:
Mieloidna blastna kriza:
95 (37%) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“ pretreated patients”) whereas 165 (63%) had not (“ untreated patients”).
95 bolnikov (37%) je imelo predhodno kemoterapijo za zdravljenje bodisi pospešene faze bodisi blastne krize (» predhodno zdravljeni bolniki «), medtem ko 165 bolnikov (63%) ni bilo predhodno zdravljenih (» nezdravljeni bolniki «).
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia, or return to chronic phase CML using the same criteria as for the study in accelerated phase.
Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega bodisi kot popolni hematološki odziv, kot odsotnost dokazov levkemije ali kot vrnitev v kronično fazo CML, pri čemer so uporabljali enaka merila kot pri študiji v pospešeni fazi.
The rate of
V tej študiji je 31% bolnikov doseglo hematološki odziv (36% pri predhodno nezdravljenih bolnikih in 22% pri predhodno zdravljenih bolnikih).
16 response was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Stopnja odziva je bila tudi večja pri bolnikih, zdravljenih s 600 mg (33%), kot pri bolnikih, zdravljenih s 400 mg (16%, p=0, 0220).
The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Tekoča ocena povprečnega preživetja predhodno nezdravljenih in zdravljenih bolnikov je bila 7, 7 in 4, 7 meseca.
The rate of haematological response was 70% with a duration of 2– 3 months.
Stopnja hematološkega odziva je bila 70%, njegovo trajanje pa 2– 3 mesece.
Table 4
17 Preglednica 4
Response in adult CML studies
Odziv pri odraslih bolnikih s CML v kliničnih
Study 0110
Študija 0110 podatki pri 37 mesecih
Study 0109
Študija 0109 podatki pri 40, 5 meseca
Study 0102
Študija 0102 podatki pri 38 mesecih
Chronic phase, IFN failure (n=532)
kronična faza, neuspeh IFN (n=532)
Accelerated phase (n=235)
pospešena faza (n=235)
Myeloid blast crisis (n=260)
mieloidna blastna kriza (n=260)
% of patients (CI95%) 1 Haematological response Complete haematological response (CHR)
% bolnikov (CI95%) 1 Hematološki odziv popolni hematološki odziv (CHR)
95% (92.3– 96.3) 95%
(92, 3– 96, 3) 95%
Not applicable
smiselno ne uporablja
Return to chronic phase (RTC) 2
vrnitev v kronično fazo (RTC)
Major cytogenetic response Complete
Pomemben citogenetični odziv2 popoln
1
(potrjen3) [95% - ni interval zaupanja]
(Confirmed3) [95% CI] Partial
(43%) [38, 6– 47, 2]
[0.6– 4.4] 8%
[0, 6– 4, 4]]
Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po ≥ 4 tednih):
Study 0110 [WBC < 10 x 109/ l, platelets < 450 x 109/ l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/ l, platelets ≥ 100 x 109/ l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/ l and platelets ≥ 20 x 109/ l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
CHR študija 0110 [WBC < 10 x 109/ l, trombociti < 450 x 109/ l, mielociti+metamielociti < 5% v krvi, brez blastov in promielocitov v krvi, bazofilci < 20%, brez prizadetosti zunaj kostnega mozga] in v študijah 0102 in 0109 [ANC ≥ 1, 5 x 109/ l, trombociti ≥ 100 x 109/ l, brez blastov v krvi, BM blasti < 5% in brez obolelosti zunaj kostnega mozga] NEL enaki kriteriji kot za CHR, a ANC ≥ 1 x 109/ l in trombociti ≥ 20 x 109/ l (samo 0102 in 0109) RTC < 15% blastov v BM in PB, < 30% blastov+promielocitov v BM in PB, < 20% bazofilcev v PB, brez obolelosti zunaj kostnega mozga, razen v vranici in jetrih (samo za 0102 in 0109).
BM = bone marrow, PB = peripheral blood 2 Cytogenetic response criteria:
BM = kostni mozeg, PB = periferna kri 2 Kriteriji citogenetičnega odziva:
A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1– 35%) 3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Pomemben odziv združuje tako popolne kot delne odzive: popoln (0% Ph+ metafaz), delen (1– 35%) 3 Popoln citogenetični odziv, potrjen z drugo citogenetično oceno kostnega mozga, opravljeno vsaj en mesec po prvi študiji kostnega mozga.
A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
V preskušanje stopnjevanja odmerka prve faze so vključili skupaj 26 pediatričnih bolnikov, starih < 18 let, bodisi s kronično fazo CML (n=11) bodisi s CML v blastni krizi ali Ph+ akutnimi levkemijami (n=15).
This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
To je bila skupina že prej močno zdravljenih bolnikov, saj jih je pred začetkom raziskave 46% prejelo BMT, 73% pa kemoterapijo z več zdravili.
Patients were treated at doses of Glivec of 260 mg/ m2/ day (n=5), 340 mg/ m2/ day (n=9), 440 mg/ m2/ day (n=7) and 570 mg/ m2/ day (n=5).
Bolniki so bili zdravljeni z odmerki zdravila Glivec 260 mg/ m2/ dan (n=5), 340 mg/ m2/ dan (n=9), 440 mg/ m2/ dan (n=7) in 570 mg/ m2/ dan (n=5).
Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44%) and 3 (33%) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77%.
Od 9 bolnikov s kronično fazo CML in razpoložljivimi citogenetičnimi podatki so 4 (44%) in 3 (33%) bolniki dosegli popolni oziroma delni citogenetični odziv pri 77- odstotni stopnji MCyR.
A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
V odprto, multicentrično preskušanje faze II z eno skupino so vključili skupno 51 pediatričnih bolnikov z na novo diagnosticirano in nezdravljeno CML v kronični fazi.
Patients were treated with Glivec 340 mg/ m2/ day, with no interruptions in the absence of dose limiting toxicity.
Bolniki so bili zdravljeni z odmerki zdravila Glivec 340 mg/ m2/ dan brez prekinitev; toksičnih učinkov, zaradi katerih bi zmanjševali odmerjanje, ni bilo.
Glivec treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Zdravljenje z zdravilom Glivec povzroči hiter odziv pri na novo diagnosticiranih pediatričnih bolnikih s popolnim hematološkim odzivom 78% po 8 tednih zdravljenja.
The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Ob veliki stopnji popolnega hematološkega odziva je prišlo tudi do popolnega citogenetičnega odziva (CCyR) v 65%, kar je primerljivo z zabeleženimi rezultati pri odraslih.
The
Poleg tega so zabeležili tudi delen citogenetični odziv (PCyR) pri 16% bolnikov ob 81% s pomembnim citogentičnim odzivom.
17 majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Večina bolnikov, ki je dosegla popolni citogenetični odziv, ga je dosegla med 3. in 10. mesecem s povprečnim časom do odziva 5, 6 meseca glede na Kaplan- Meierjevo oceno.
Clinical studies in Ph+ ALL Newly diagnosed Ph+ ALL:
Klinične študije pri Ph+ ALL
50%; p=0.0001).
V kontrolirani študiji (ADE10) imatiniba v primerjavi z indukcijo s kemoterapijo pri 55 bolnikih z novo odkrito boleznijo, ki so bili stari 55 let ali več, je imatinib kot edino zdravilo povzročil značilno večji delež bolnikov s popolnim hematološkim odzivom kot kemoterapija (96, 3% v primerjavi s 50%; p=0, 0001).
When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8%) out of 11 achieving a complete haematological response.
Ko so imatinib uporabili kot reševalno zdravljenje pri bolnikih, pri katerih ni bilo odziva ali pa je bil odziv na kemoterapijo slab, je 9 bolnikov od 11 (81, 8%) doseglo popolni hematološki odziv.
This clinical effect was associated with a higher reduction in bcr- abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Ta klinični učinek je bil povezan z večjim zmanjšanjem količine transkriptov bcr- abl pri bolnikih, zdravljenih z imatinibom, kot pri skupini, zdravljeni s kemoterapijo po 2 tednih zdravljenja (p=0, 02).
All patients received imatinib and consolidation chemotherapy (see Table 5) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Ravni transkriptov bcr- abl so bile po 8 tednih v obeh krakih enake.
As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p=0.01) and disease-free survival (p=0.02).
Kot je bilo pričakovati glede na načrt študije, ni bilo nobene razlike v trajanju remisij, preživetju brez bolezni ali preživetju nasploh, čeprav so imeli bolniki s popolnim molekularnim odzivom in tisti z minimalno rezidualno boleznijo boljši izid glede trajanja remisije (p=0, 01) in preživetja brez bolezni (p=0, 02).
Imatinib in combination with chemotherapy induction (see Table 5) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Imatinib je v kombinaciji z indukcijo s kemoterapijo (glejte preglednico 5) povzročil popolni hematološki odziv pri 93% (147 od 158 za oceno primernih bolnikov) in pomembni citogenetični odziv pri 90% (19 od 21 za oceno primernih bolnikov).
The complete molecular response rate was 48% (49 out of 102 evaluable patients).
Delež bolnikov s popolnim molekularnim odzivom je bil 48% (49 od 102 za oceno primernih bolnikov).
Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p < 0.001; OS p < 0.0001) in two studies (AJP01 and AUS01).
V dveh študijah (AJP01 in AUS01) sta preživetje brez bolezni (DSF - disease- free survival in celokupno preživetje (OS - overall survival) pogosto presegala 1 leto in sta bila daljša kot pri zgodovinskih kontrolah (DFS p < 0, 001; OS p < 0, 0001).
Chemotherapy regimen used in combination with imatinib
Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom
Study ADE10
Študija ADE10 predhodna faza
DEX 10 mg/ m2 oral, days 1-5; CP 200 mg/ m2 i. v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
DEX 10 mg/ m2 peroralno, 1. - 5. dan; CP 200 mg/ m2 i. v., 3., 4., 5. dan; MTX 12 mg intratekalno, 1. dan DEX 10 mg/ m2 peroralno, 6. - 7., 13. - 16. dan; VCR 1 mg i. v., 7. in
DEX 10 mg/ m2 oral, days 6-7, 13-16; VCR 1 mg i. v., days 7, 14; IDA 8 mg/ m2 i. v.
indukcija remisije 14. dan; IDA 8 mg/ m2 i. v.
(0.5 h), days 7, 8, 14, 15; CP 500 mg/ m2 i. v. (1 h) day 1; Ara- C 60 mg/ m2 i. v., days 22-25, 29-32
(0, 5 ur), 7., 8., 14., 15. dan; CP 500 mg/ m2 i. v. (1 ura) 1. dan; Ara- C 60 mg/ m2 i. v., 22. - 25., 29. - 32. dan MTX 500 mg/ m2 i. v.
(24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20
(24 ur), 1., 15. dan; 6- MP 25 mg/ m2 peroralno, 1. - konsolidacijska
Consolidation therapy II, IV Study AAU02
terapija I, III, V konsolidacijska
Ara-C 75 mg/ m2 i. v.
20. dan Ara- C 75 mg/ m2 i. v.
(1 h), days 1-5; VM26 60 mg/ m2 i. v.
(1 ura), 1. - 5. dan; VM26 60 mg/ m2 i. v.
(1 h), days 1-5
(1 ura), 1. -
Induction therapy (de novo Ph+ ALL)
terapija II, IV Študija AAU02 indukcijsko zdravljenje (novo odkrita Ph+ ALL) konsolidacija (novo
Daunorubicin 30 mg/ m2 i. v., days 1-3, 15-16; VCR 2 mg total dose i. v., days 1, 8, 15, 22; CP 750 mg/ m2 i. v., days 1, 8; prednisone 60 mg/ m2 oral, days 1-7, 15-21; IDA 9 mg/ m2 oral, days 1-28; MTX 15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
5. dan daunorubicin 30 mg/ m2 i. v., 1. - 3., 15. - 16. dan; VCR skupni odmerek 2 mg i. v., 1., 8., 15., 22. dan; CP 750 mg/ m2 i. v., 1., 8. dan; prednizon 60 mg/ m2 peroralno, 1. - 7., 15. - 21. dan; IDA 9 mg/ m2 peroralno, 1. - 28. dan; MTX 15 mg intratekalno, 1., 8., 15., 22. dan; Ara- C 40 mg intratekalno, 1., 8., 15., 22. dan; metilprednizolon 40 mg intratekalno, 1., 8., 15., 22. dan Ara- C 1. 000 mg/ m2/ 12 ur i. v. (3 ure), 1. - 4. dan; mitoksantron 10 mg/ m2
Consolidation (de novo Ph+ ALL) Study ADE04
odkrita Ph+ ALL) Študija ADE04 predhodna faza indukcijsko zdravljenje I indukcijsko zdravljenje II konsolidacijsko
Prephase
i. v.