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Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
Remission Induction:
Results:
1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
Intrathecal chemotherapy:
Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT 1
Start in two weeks after last dose of induction chemotherapy:
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
TRANSPLANTATION
Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.
Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1
Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vincristine | Drug | 1,5 mg/m2 i.v., days 1 and 8 | ||
| Daunorubicin | Drug | 60 mg/m2, i.v., days 1 and 8 | ||
| Prednisone | Drug | 60 mg/m2 day, i.v. or oral, days 1 to 14 | ||
| L-Asparaginase | Drug | 10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses. | ||
| Mitoxantrone | Drug | 12 mg/m2 i.v days 15, 16 and 17 | ||
| Cytosine Arabinoside | Drug | 1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival | 5 years |
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Inclusion Criteria:
ALL BCR/ABL+ patients Age < 65 years No previous treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ribera Josep Mª, Dr | Germans Trias i Pujol Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Alicante | Alicante | Alicante | Spain | |||
| Hospital Ntra. Sra. Sonsoles |
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| Label | URL |
|---|---|
| Spanish Association of Haematology | View source |
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| Hydrocortisone | Drug | 10 mg ,15 mg or 20 mg depending of age |
| Mercaptopurine | Drug | 50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation |
| Cyclophosphamide | Drug | 600 mg/m2 day, i.v., days 1 to 15 in consolidation |
| Dexamethasone | Drug | 10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21 |
| Ávila |
| Avila |
| Spain |
| Hospital Clínic | Barcelona | Barcelona | Spain |
| Hospital del Mar | Barcelona | Barcelona | Spain |
| Hospital vall d'Hebrón | Barcelona | Barcelona | Spain |
| Hospital general de Castellón | Castelló | Castellón | Spain |
| Hospital Arnau de Vilanova | Lleida | Lleida | Spain |
| Hospital Clínico San Carlos de Madrid | Madrid | Madrid | Spain |
| Hospital General Universitario Gregorio Marañón, Madrid | Madrid | Madrid | Spain |
| Hospital Universitario de la Princesa | Madrid | Madrid | Spain |
| Hospital General Universitario Morales Meseguer. | Murcia | Murcia | Spain |
| . Hospital Clínico Universitario Virgen de la Victoria | Málaga | Málaga | Spain |
| Hospital de Navarra | Pamplona | Navarre | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | Spain |
| Hospital Verge de la Cinta | Tortosa | Tarragona | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Valencia | Spain |
| Hospital Clínic | Valencia | Valencia | Spain |
| Hospital dr. Peset | Valencia | Valencia | Spain |
| Hospital General Universitario | Valencia | Valencia | Spain |
| Hospital La Fe | Valencia | Valencia | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | Zaragoza | Spain |
| Complejo Hospitalario Universitario de Albacete | Albacete | Spain |
| Hospital de Badalona Germans Trias i Pujol | Badalona | Spain |
| Hospital de Sant Pau | Barcelona | Spain |
| Basurtuko Ospitalea | Basurto | Spain |
| Hospital de Cruces | Bilbao | Spain |
| Hospital de Jerez de la Frontera | Jerez de la Frontera | Spain |
| Complejo Hospitalario León | León | Spain |
| Complexo Hospitalario Xeral-Calde | Lugo | Spain |
| Clínica Puerta de Hierro | Madrid | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital de la Princesa | Madrid | Spain |
| Althaia, Xarxa Asistencial de Manresa | Manresa | Spain |
| H. Carlos Haya | Málaga | Spain |
| Hospital General Morales Meseguer | Murcia | Spain |
| Hospital Santa María del Rosell | Murcia | Spain |
| Complejo Asistencial Son Dureta | Palma de Mallorca | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Spain |
| Clínica Universitaria de Navarra | Pamplona | Spain |
| Complejo Hospitalario de Pontevedra_Hospital Montecelo | Pontevedra | Spain |
| Corporació Sanitaria Parc Taulí | Sabadell | Spain |
| Hospital de Sagunto | Sagunto | Spain |
| Hospital Clínico Universitario de Salamanca | Salamanca | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Spain |
| Hospital General de Segovia | Segovia | Spain |
| H.U. Virgen del Rocio | Seville | Spain |
| Hospital Clínico de Valladolid | Valladolid | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Spain |
| Hospital de Galdakao | Vizcaya | Spain |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| D003630 | Daunorubicin |
| D011241 | Prednisone |
| D001215 | Asparaginase |
| D008942 | Mitoxantrone |
| D003561 | Cytarabine |
| D006854 | Hydrocortisone |
| D015122 | Mercaptopurine |
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
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