AIDA 2000 Guidelines – CheckOrphan

Brief Title

AIDA 2000 Guidelines

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group

Condition

Acute Promyelocytic Leukemia

Intervention

all-trans retinoic acid (ATRA)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 2000

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

Gender

All

Ages

1 Year - 60 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT01064570

Organization ID

AIDA2000

Study Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Sponsor

, ,

Verification Date

October 2020