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Treatment of Acute Promyelocytic Leukemia: Remission Induction With ATRA + Idarubicin (AIDA) Risk Adapted Intensity of Consolidation and Addition of ATRA Maintenance With ATRA + Methotrexate + Mercaptopurine Salvage Therapy for Molecular and Haematological Relapses


Phase 4
N/A
75 Years
Not Enrolling
Both
Acute Promyelocytic Leukemia

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Trial Information

Treatment of Acute Promyelocytic Leukemia: Remission Induction With ATRA + Idarubicin (AIDA) Risk Adapted Intensity of Consolidation and Addition of ATRA Maintenance With ATRA + Methotrexate + Mercaptopurine Salvage Therapy for Molecular and Haematological Relapses


Induction chemotherapy:

All-trans retinoic acid, will be administered by mouth (PO) from the first day at a dose of
45 mg/m²/day, fractionated into 2 doses.

In patients aged < 20 years, the ATRA dose will be reduced to 25 mg/m²/day fractionated into
2 doses.

The treatment with ATRA will continue until a CR is achieved or for a maximum of 90 days in
the case of persistence of atypical promyelocytes in the bone marrow.

Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 of treatment by slow intravenous infusion (20
minutes).

In patients older than 70 years of age only 3 doses of idarubicin will be given on days 2,
4, and 6.

Supporting measures:

Prednisone, 0.5 mg/kg/day days 1 to 15. Tranexamic acid, 100 mg/kg/day in continuous
perfusion, if platelets < 50 x 10^9/L or evident clinical-biological signs of coagulopathy.
This treatment will be discontinued if the platelet counts are > 50 x 10^9/L.

Transfusion of platelet concentrates to keep up counts above 30 x 10^9/L during the first 10
days and PRC to maintain hemoglobin levels greater than 9 g/dL.

Prophylactic heparin should not be used.


Inclusion Criteria:



- Age <= 75 years

- ECOG = 3.

- Morphological diagnosis of M3 or M3v. Those cases without typical morphology but with
PML-RARa rearrangement may also be included.

- Genetic diagnosis: t(15;17), PML-RARa rearrangement, monoclonal anti-PML positive.
Obviously, the result of these tests may become available after having initiated the
treatment based on a tentative morphological diagnosis. The presence of secondary
cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do
they require a different therapeutic approach.

Exclusion Criteria:

- Age > 75 years (the treatment with this protocol can be considered on an individual
basis but these patients will be analysed separately)

- Absence of PML-RARa rearrangement.

- Prior antileukemic chemotherapy.

- Presence of an associated neoplasm.

- Presence of a severe psychiatric disease.

- HIV seropositivity.

- Contraindication for intensive chemotherapy, especially to anthracyclines.

- Serum creatinine = 2.5 mg/dL.

- Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit

- Positive pregnancy test.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of AIDA with a dose reduction in patients older than 70 years of age in the remission induction of APL

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Sanz Miguel Angel, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

HOSPITAL LA FE VALENCIA

Authority:

Spain: Ministry of Health

Study ID:

Pethema LPA-99 protocol

NCT ID:

NCT00465933

Start Date:

March 1999

Completion Date:

November 2007

Related Keywords:

  • Acute Promyelocytic Leukemia
  • Acute Promyelocytic Leukemia
  • AIDA
  • Leukemia
  • Leukemia, Promyelocytic, Acute

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