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Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease


Phase 4
N/A
65 Years
Not Enrolling
Both
Acute Myeloblastic Leukemia

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Trial Information

Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease


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.


Inclusion Criteria:



- Age< or =65 years.

- ECOG<=3.

- AML of new diagnose.

- Consent for chemotherapy.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Diaz Mediavilla Joaquin, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Clínico Universitario San Carlos

Authority:

Spain: Ministry of Health

Study ID:

AML99<=65 años

NCT ID:

NCT00390715

Start Date:

January 1999

Completion Date:

January 2010

Related Keywords:

  • Acute Myeloblastic Leukemia
  • Acute Myeloblastic Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Neoplasm, Residual

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