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Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin


N/A
1 Year
75 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin


Inclusion Criteria:



- Age > 12 months (1 year) and < 75 years

- Morphological newly diagnosis of APL

- Presence of the PML-RARa transcript

- No cardiac contraindications to anthracycline chemotherapy

- Serum creatinine <=2.5 mg/dL

- Serum alkaline phosphatase <= 3 times the normal upper limit

- Serum bilirubin <= 3 times the normal upper limit

- Serum SGOT <= 3 times the upper normal limit

- Negative pregnancy test

- Informed consent

Exclusion Criteria:

- Age <= 12 months and >=75 years

- absence of the PML-RARa transcript

- Preganant of lactating women

- Presence of active serious infections that are not controlled by antibiotics

- Prior treatment with antileukemic therapy (excluded corticosteroids)

- Presence of severe concomitant psychiatric disease

- Presence of other concomitant malignant tumors, except basal cell carcinoma

- Concurrent treatment with cytotoxic chemotherapy or radiotherapy

- Cardiac contraindications to anthracycline chemotherapy

- Serum creatinine >2.5 mg/dL

- Serum alkaline phosphatase > 3 times the normal upper limit

- Serum bilirubin > 3 times the normal upper limit

- Serum SGOT > 3 times the upper normal limit

- Positive pregnancy test

- Absence of informed consent

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.

Authority:

Italy: Ethics Committee

Study ID:

AIDA0493

NCT ID:

NCT01064557

Start Date:

October 1993

Completion Date:

Related Keywords:

  • Leukemia
  • Acutypromyelocytic Leukemia
  • Leukemia

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