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Search / Trial NCT01064570

Trial Information

Current as of June 04, 2025

Unknown status

Keywords

Acute Promyelocytic Leukemia Apl

ClinConnect Summary

No description provided

Gender

ALL

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

About Gruppo Italiano Malattie Ematologiche Dell'adulto

The Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) is a prestigious Italian research group dedicated to advancing the understanding and treatment of adult hematological diseases. Comprising a network of leading hematologists and clinical researchers, GIMEMA conducts innovative clinical trials aimed at improving patient outcomes through the development of novel therapeutic strategies and evidence-based practices. With a strong emphasis on collaboration and scientific rigor, GIMEMA plays a pivotal role in enhancing the landscape of hematology both in Italy and internationally, contributing significantly to the global body of research and clinical knowledge in this critical field.

Locations

Roma, , Italy

Bari, , Italy

Pavia, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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