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Guidelines for Treatment of Acute Promyelocytic Leukemia


Phase 2
1 Year
60 Years
Open (Enrolling)
Both
Acute Promyelocytic Leukemia

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Trial Information

Guidelines for Treatment of Acute Promyelocytic Leukemia


Inclusion Criteria:



- Age >= 1 years and < 61 years

- Morphologic diagnosis of APL

- PS <= 3

- Presence in leukemic cells at diagnosis of t(15;17), and/or PML/RARa rearrangement by
RT-PCR. T

- The presence of additional cytogenetic lesions is not considered an exclusion
criterion

- Serum creatinine <=2.5 mg/dL

- Serum bilirubin, alkaline phosphatase, or GOT/ASAT <= 3 times the upper normal limit

- Negative pregnancy test

- Written informed consent

Exclusion Criteria:

- Age >= 61 years

- Prior antileukemic chemotherapy for APL

- Absence of PML-RARa rearrangement after successful RNA extraction and amplification
of control gene

- Prior antileikemic chemotherapy for APL

- Presence of a concomitant malignant neoplasm, except basal cell carcinoma Concurrent
treatment with cytotoxic chemotherapy or radiotherapy

- Oteher progressive malignant disease. However, secondary acute promyelocytic leukemia
following "cured" Hodgkin's disease or otehr cured malignancies may be included, as
well as secondary leukemias following other exposure to alkylating agents or
radiation for other reasons

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related toxicity event rate during the ATRA-including consolidation treatment

Outcome Time Frame:

At the end of the study

Safety Issue:

No

Authority:

Italy: Ethics Committee

Study ID:

AIDA2000

NCT ID:

NCT01064570

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Acute Promyelocytic Leukemia
  • Acute Promyelocytic Leukemia
  • APL
  • Leukemia
  • Leukemia, Promyelocytic, Acute

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