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To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction
INDUCTION TREATMENT :Ara-C 100 mg/m 2 /day in continuous perfusion,days 1 - 7. Idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. GM-CSF (Leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (> 1.000/mm 3)
CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. The patients who do not reach a complete response with the first cycle will receive a second cycle. If after two cycles,do not obtain the response, patient should leave the protocol.
INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ARA-C 500 mg/m 2 /12 h in one hour infusion, days 1-4. Daunomycin 45 mg/m 2 /day bolu, days 5-7. GM-CSF (Leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (>1.000/mm 3)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARA-C | Drug | |||
| Idarubicin | Drug | |||
| Leucomax | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the toxicity | ||
| Evaluate the effect of haematopoietic growth factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garcia Laraña Jose, Dr | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Albacete | Albacete | Spain | ||||
| Hospital Universitario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24117042 | Derived | Martinez-Lopez J, Fernandez-Redondo E, Garcia-Sanz R, Montalban MA, Martinez-Sanchez P, Pavia B, Mateos MV, Rosinol L, Martin M, Ayala R, Martinez R, Blanchard MJ, Alegre A, Besalduch J, Bargay J, Hernandez MT, Sarasquete ME, Sanchez-Godoy P, Fernandez M, Blade J, San Miguel JF, Lahuerta JJ; GEM (Grupo Espanol Multidisciplinar de Melanoma)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. Clinical applicability and prognostic significance of molecular response assessed by fluorescent-PCR of immunoglobulin genes in multiple myeloma. Results from a GEM/PETHEMA study. Br J Haematol. 2013 Dec;163(5):581-9. doi: 10.1111/bjh.12576. Epub 2013 Oct 3. |
| Label | URL |
|---|---|
| Spanish association of Haematology | View source |
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| Alicante |
| Spain |
| Hospital Puerta del Mar | Cadiz | Spain |
| Hospital Ntra. Sra. del Rossell | Cartagena | Spain |
| Hospital General | Castellon | Spain |
| Hospital de Galdacano | Galdakao | Spain |
| Hospital Ciudad de Jaén | Jaén | Spain |
| Hospital Insular de las Palmas | Las Palmas de Gran Canaria | Spain |
| Hospital Xeral | Lugo | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Universitario de Alcalá de Henares | Madrid | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| Hospital Morales Messeguer | Murcia | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital Central de Asturias | Oviedo | Spain |
| Clínica Universitaria de Pamplona | Pamplona | Spain |
| Hospital Montecelo | Pontevedra | Spain |
| Hospital Clínico Universitario | Salamanca | Spain |
| Hospital Arnau de Vilanova | Valencia | Spain |
| Hospital Clínico | Valencia | Spain |
| Hospital Dr. Pesset | Valencia | Spain |
| Hospital Clínico | Valladolid | Spain |
| Hospital Virgen de la Concha | Zamora | Spain |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| C082430 | molgramostim |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| 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 |
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