Acute Myeloid Leukemia Clinical Trial
— FLATOfficial title:
FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Verified date | November 2008 |
Source | PETHEMA Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 47 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subjects of 18 years of age or major, with diagnosis of primary or secondary AML, confirmed cytologically, that fulfill one of the following conditions: - Do not reach a CR after the conventional treatment. - Relapse in the first 12 months after a CR. During remission, patients can have be treated by a transplant. The relapse is defined as the presence of blasts in peripheric blood or the presence of >5 % of blasts in MO. - Not participation in a clinical trial. 2. ECOG < o = 2 3. Considered suitable patients for an intensive chemotherapy 4. Informed consent Exclusion Criteria: 1. Pelvic or spinal radiotherapy in 4 weeks before the incorporation in the protocol. 2. Acute promyelocytic leukaemia 3. First line chemotherapy for AML which has contained fludarabine or topotecan. 4. Active or chronic hepatitis or hepatic cirrhosis. 5. Positivity known to the virus of the human immunodeficiency (HIV) 6. Pregnant or breastfeeding patients. 7. Patients with deterioration of the functions hepatic or renal, defined for the following values base them of laboratory: - AST or ALT >2,5 times the top limit of the normality of the center (LSNC) - Alkaline phosphatase >2,5 times the LSNC - Total bilirubin value >2 times the LSNC - Creatinine value >2 times the LSNC after a suitable hydration 8. Precedents of intervention of major surgery in 2 weeks before the incorporation in the protocol. 9. Patients with disease serious or not controlled (for example not controlled diabetes, infection, hypertension, etc.). 10. Patients who have received other cytotoxic drugs (except hydroxyurea to reduce the leucocytosis) as treatment of the current relapse or of the resistance, in 4 weeks before the protocol. 11. Patients with hypersensitivity known to someone of the drugs of the protocol. 12. Patients treated previously with growth factors with purposes of sensibilization. 13. Patients with psychological, intellectual or sensitive dysfunction that can reduce his capacity of comprehension and fulfillment of the protocol. 14. Patients treated before with FLAT. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | 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 |
Lead Sponsor | Collaborator |
---|---|
PETHEMA Foundation |
Spain,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To treat with the combination FLAT patients with acute myeloid leukaemia that they present a primary resistance | one month | ||
Primary | •To treat with the combination FLAT a relapse in the first 12 months after reach the first CR with standard treatment | one month | ||
Primary | To treat with combination FLAT patients can't receive the standard treatment due any cause | one month | ||
Secondary | Improve the interval free survival and global survival | one year | ||
Secondary | To avoid the toxicities produced by other chemotherapy in this type of patients | 4 months | ||
Secondary | To determine the existing association between the response to the treatment with FLAT and the expression of Multi Drug Resistance (MDR) in the acute myeloid leukaemia | 6 months |
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