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ClinicalTrials.gov ID

NCT01064570

Lead Sponsor

Gruppo Italiano Malattie EMatologiche dell'AdultoOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

600Estimated

Last Update Posted

Oct 14, 2020Actual

Start Date

May 2000

Official Title

Guidelines for Treatment of Acute Promyelocytic Leukemia

Brief Summary

Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse.

• Acute Promyelocytic Leukemia

• all-trans retinoic acid (ATRA)

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Gruppo Italiano Malattie EMatologiche dell'AdultoOTHER

gimema@gimema.it