⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Fludarabine, Cytarabine, Topotecan in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Fludarabine, Cytarabine, Topotecan in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Official Title: FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

Study ID: NCT00488709

Study Description

Brief Summary: The study is designed with drugs used frequently in the treatment of AML, but with a new combination less toxic,and effective in AML multidrug resistant. Justification: * The AML patients with primary resistance or relapsed in the first 12 months after CR, have second line chemotherapy low response rate . * These patients with AML with primary resistance or relapse, that reach remission after a rescue treatment, have an interval free survival and a global survival very short * Probably the resistance to the treatments is in relation to different forms expression of the MDR. * Complete remission is considered valid evaluation, because every patient who should obtain a CR can be considered to be eligible for a possible curative treatment: Ara-C administration to high doses or the TPH treatment

Detailed Description: It is a protocol opened, multicentric, led to end to increase a) the rate of complete responses, b) the duration of the response, c) the free survival of disease and d) the global survival. The included subjects will be patients with primary or secondary AML that they have not achieved the CR after the standard treatment with an anthracycline or derivative associated with Ara-C or have relapsed in the first 12 months after having achieved the RC. Also patients with AML that, for any reason, they could not receive the standard treatment with anthracycline and Ara-C, will be included Cycle of induction. The patients will be treated by FLAT according to the following scheme: * FLUDARABINE, 30 mg/m2 i.v. (In 1 hour) on the 1st to 4. * CITARABINE, 2 g/m2 i.v. (In 4 hours), four hours after finishing the fludarabine, on the 1st to 4. * TOPOTECAN, 1,5 mg/m2 i.v. (In 4 hours), four hours after finishing the cytarabine, on the 1st to 4. When the patient starts recovering the hematological counts, and providing that has not blasts in the peripheral blood (SP), he will become a medullar revision (MO): * If MO presents severe hypocellularity without blasts,no therapeutic measurement will take and there will repeat revisions weekly and MDR's study up to the CR or the blasts appearance. * If in MO persist blasts (\>5 %) but have diminished less than 50 % of the initial number, the induction will be continued by the FLAT's second shift. * If in MO persists more than 50 % of blasts of the initial number, the patient goes out of the protocol and it will be treated as an agreement by the criterion of the center. The patients who have managed to enter CR will receive a cycle of consolidation as soon as possible and always within 2 months from the day in which they received first FLAT's dose. The cycle of consolidation consists of another FLAT's scheme to the same doses.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Juan Canalejo, A Coruña, , Spain

Hospital Ntra. Sra. de Sonsoles, Avila, , Spain

Hospital germans Trias i Pujol, Badalona, , Spain

Centro Médico Teknon, Barcelona, , Spain

Hospital Sant Pau, Barcelona, , Spain

Hospital Vall d'Hebron, Barcelona, , Spain

Hospital General Yagüe, Burgos, , Spain

Hospital de Jerez, Cadiz, , Spain

Complejo hospitalario Xeral-Calde, Lugo, , Spain

Hospital Clínico Universitario San Carlos, Madrid, , Spain

Hospital Ramón y Cajal, Madrid, , Spain

Hospital Virgen de la Victoria, Málaga, , Spain

Hosptal Joan XXIII, Tarragona, , Spain

Hospital Verge de la Cinta, Tortosa, , Spain

Hospital Rio Hortega, Valladolid, , Spain

Hospital Clinico Lozano Blesa, Zaragoza, , Spain

Contact Details

Name: Bueno Javier, Dr

Affiliation: Hospital Vall d'Hebron

Role: STUDY_CHAIR

Name: Sanchez Eva, Dr

Affiliation: Hospital Vall d'Hebron

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: