"AIDA" Protocol (LAP 0493)

This study is currently recruiting participants.
Verified March 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01064557
First received: February 5, 2010
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.


Condition Intervention
Leukemia
Drug: all-trans retinoic acid (ATRA)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guideline for the 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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase [ Designated as safety issue: No ]
  • To evaluate the role of maintenance therapy with ATRA and chemotherapy in PCR positive patients at the end of the consolidation phase not eligible for a BMT procedure [ Designated as safety issue: No ]
  • To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin [ Designated as safety issue: No ]

Estimated Enrollment: 1068
Study Start Date: October 1993
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Pregnant 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064557

Contacts
Contact: Paola Fazi p.fazi@gimema.it
Contact: Enrico Crea e.crea@gimema.it

  Show 80 Study Locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
  More Information

Additional Information:
Publications:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01064557     History of Changes
Other Study ID Numbers: AIDA0493
Study First Received: February 5, 2010
Last Updated: March 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acute promyelocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014