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Sponsored by: |
PETHEMA Foundation |
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Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00390715 |
study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.
Condition | Intervention | Phase |
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Acute Myeloblastic Leukemia |
Drug: chemotherapy |
Phase IV |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease |
Estimated Enrollment: | 600 |
Study Start Date: | January 1999 |
Estimated Study Completion Date: | January 2008 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
AML of new diagnose, no treated previously
Inclusion Criteria:
Study Chair: | Diaz Mediavilla Joaquin, Dr | Hospital Clínico Universitario San Carlos |
Responsible Party: | pethema ( Pethema ) |
Study ID Numbers: | AML99<=65 años |
Study First Received: | October 18, 2006 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00390715 History of Changes |
Health Authority: | Spain: Ministry of Health |
Acute Myeloblastic Leukemia |
Neoplasm, Residual Leukemia Acute Myelocytic Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute |
Neoplasm, Residual Leukemia Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |