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Spots Global Cancer Trial Database for Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

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Trial Identification

Brief Title: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

Official Title: APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

Study ID: NCT00504764

Study Description

Brief Summary: Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia. By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be reached. On average, about 10% of patients still die in the early phase of the treatment and about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the individual kinetics of MRD and to identify patients with an imminent hematological relapse. A standardized treatment for patients with relapsed APL has not yet been established. With arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower concentrations. ATO was also successfully administered before allogeneic and autologous transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe and in the USA. After remission induction, there are several options for postremission therapy Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg

Detailed Description: Induction ATO 0.15 mg/kg/día IV in continuous perfusion 1-2 hours/day until complete response (CR) or maximum of 60 days. Oral hydroxyurea treatment (initial dose 2 g/day)is recommended in patients with leucocyte counts at relapse \>10x109/L or in the two first weeks of induction. Isolated molecular relapsed patients will be treated with ATO (same dose) 5 days at week, during 6 weeks. Consolidation ATO 0.15 mg/kg/día IV 5 days at week, during 5 weeks, combined with oral ATRA 45 mg/m²/day during the same 5 weeks. Post-consolidation therapy TPH (autologous or allogenic) in candidate patients. In case of molecular remission, is recommended autologous-TPH. Patients no candidates to auto-TPH or alo-TPH, should will follow treatment with ATO cycles + ATRA +/- Mylotarg. 1. Option Alo-TPH If PCR post-consolidation is negative is recommended auto-TPH. However, if alo-TPH is decided, it will be done immediately without preceding chemotherapy. If PCR post-consolidation is positive, should done alo-TPH. 2. Option Auto-TPH If PCR post-consolidation is negative it will be administered one cycle of MTZ + Ara-C follow by auto-TPH. In cas of failure: a) if patient has autologous stem cells preserved (PCR negative) are suitable for auto-TPH; b) patients with HLA-compatible donor who are suitable for allogenic stem cell transplantation should be transplanted; c) Patients who are not eligible for allogenic or autologous transplantation, receive various cycles with ATO + ATRA combined or not with Mylotarg. If PCR post-consolidation is positive and patient is eligible for allogenic TPH, should be done a allogenic TPH. If patient is no eligible for allogenic TPH or dont has compatible donor, will be administrate one cycle of MTZ + Ara-C and collect stem cells. Autologous transplantation will be done if after this cycle, a molecular remission is obtained. No molecular remission or no enough stem cells collection, patient follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg. 3. ATO + ATRA combined or no with Mylotarg Patients no eligible to autologous TPH or allogenic TPH follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg. If Mylotarg is no possible, treatment will be with subsequent cycles of ATO + ATRA. ATO + ATRA + Mylotarg: Mylotarg 6 mg/m2 day 1, ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15. Doses of mylotarg should be reduced to 3 mg/m2 in patients aged over 60 years. Administration of 3 cycles with a month interval, follow of 3 to 6 cycles of ATO + ATRA without Mylotarg. After, ATRA 45 mg/m2/d 15 days every 3 months until complete two years of maintenance. ATO + ATRA: ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15, every 29 days. Administration of 9 cycles, and followed by ATRA 45 mg/m2/d during 15 days every 3 months until complete two years of maintenance.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Central de Asturias, Oviedo, Asturias, Spain

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Hospital de Mataró, Mataró, Barcelona, Spain

Hospital general de Castellón, Castello, Castellón, Spain

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, La Coruña, Spain

Hospital de Alcorcón, Alcorcón, Madrid, Spain

Clínica Universitaria de Navarra, Pamplona, Navarra, Spain

Hospital Verge de la Cinta, Tortosa, Tarragona, Spain

Complejo Hospitalario Universitario de Albacete, Albacete, , Spain

Fundación Hospital Alcorcón, Alcorcón, , Spain

Hospital General de Alicante, Alicante, , Spain

Hospital de la Ribera, Alzira, , Spain

Hospital Ntra. Sra. Sonsoles, Avila, , Spain

Hospital Clinic, Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Hospital Valle Hebrón, Barcelona, , Spain

Basurtuko Ospitalea, Basurto, , Spain

Hospital de Cruces, Bilbao, , Spain

Complejo Hospitalario de Cáceres, Cáceres, , Spain

Hospital Puerta del Mar, Cádiz, , Spain

Complejo Hospitalario Reina Sofía, Córdoba, , Spain

Hospital Donostia, Donostia, , Spain

Hospital General de Elda, Elda, , Spain

Hospital de Fuenlabrada, Fuenlabrada, , Spain

Hospital Virgen de las Nieves, Granada, , Spain

Hospital General de Guadalajara, Guadalajara, , Spain

Area Hospitalaria Juan Ramón Jimenez, Huelva, , Spain

Hospital de San Jorge, Huesca, , Spain

Hospital Médico Quirúrgico Ciudad de Jaén, Jaen, , Spain

Hospital de Jerez de la Frontera, Jerez de la Frontera, , Spain

Hospital Juan Canalejo, La Coruña, , Spain

Hospital General de Lanzarote, Lanzarote, , Spain

Complejo Hospitalario León, Leon, , Spain

Hospital Arnau de Vilanova, Lleida, , Spain

Complexo Hospitalario Xeral-Calde, Lugo, , Spain

Clínica La Concepción, Madrid, , Spain

Clínica Moncloa, Madrid, , Spain

Clínica Puerta de Hierro, Madrid, , Spain

Clínica Rúber, Madrid, , Spain

Fundación Jiménez Díaz, Madrid, , Spain

Hospital 12 de Octubre, Madrid, , Spain

Hospital Central de la Defensa, Madrid, , Spain

Hospital Clínico San Carlos de Madrid, Madrid, , Spain

Hospital de la Princesa, Madrid, , Spain

Hospital Doce de Octubre, Madrid, , Spain

Hospital General Universitario Gregorio Marañón, Madrid, Madrid, , Spain

Hospital la Paz, Madrid, , Spain

Althaia, Xarxa Asistencial de Manresa, Manresa, , Spain

Fundación Hospital Sant Joan de Déu de Martorell, Martorell, , Spain

Hospital General Morales Meseguer, Murcia, , Spain

. Hospital Clínico Universitario Virgen de la Victoria, Málaga, , Spain

Hospital de Mérida, Mérida, , Spain

Hospital de Móstoles, Móstoles, , Spain

Hospital del Río Carrión, Palencia, , Spain

Hospital de Gran Canaria Doctor Negrín, Palma de Gran Canaria, , Spain

Hospital Son Dureta, Palma de Mallorca, , Spain

Hospital Son Llàtzer, Palma de Mallorca, , Spain

Hospital Verge del Toro, Palma de Mallorca, , Spain

Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, , Spain

Complejo Hospitalario de Pontevedra_Hospital Provincial, Pontevedra, , Spain

Corporació Sanitaria Parc Taulí, Sabadell, , Spain

Hospital de Sagunto, Sagunto, , Spain

Hospital Clínico de Salamanca, Salamanca, , Spain

Clínica Sant Camil, Sant Pere de Ribes, , Spain

Hospital Universitario Marqués de Valdecilla, Santander, , Spain

Hospital General de Segovia, Segovia, , Spain

H.U. Virgen del Rocio, Sevilla, , Spain

Hospital Joan XXIII, Tarragona, , Spain

Hospital Universitario de Canarias, Tenerife, , Spain

Hospital Nuestra Señora del Prado, Toledo, , Spain

Fundación Instituto Valenciano de Oncología, Valencia, , Spain

Hospital Clínic, Valencia, , Spain

Hospital Dr. Peset, Valencia, , Spain

Hospital Francesc de Borja, Valencia, , Spain

Hospital General Universitario, Valencia, , Spain

Hospital La Fe, Valencia, , Spain

Hospital Clínico de Valladolid, Valladolid, , Spain

Hospital Comarcal Pius de Valls, Valls, , Spain

Complejo Hospitalario Xeral-Cies, Vigo, , Spain

Comarcal de Vinaros, Vinaros, , Spain

Hospital Txagorritxu, Vitoria, , Spain

Hospital de Galdakao, Vizcaya, , Spain

Hospital Clínico Lozano Blesa, Zaragoza, , Spain

Hospital Miguel Servet, Zaragoza, , Spain

Contact Details

Name: Sanz Miguel Angel, Dr

Affiliation: Hospital La Fe

Role: STUDY_CHAIR

Name: Esteve Jordi, Dr

Affiliation: Hospital Clinic of Barcelona

Role: STUDY_CHAIR

Name: Montesinos Pau, Dr

Affiliation: Hospital General Universitario de Valencia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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