Text Size

"AIDA" Protocol (LAP 0493)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01064557
First received: February 5, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

The main purposes of the AIDA protocol are to test teh role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at teh 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: Primary Purpose: Treatment
Official Title: 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:

Drug Information available for: Tretinoin
U.S. FDA Resources

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.

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
  • To evaluate teh 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
  • To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin

Estimated Enrollment: 1068
Study Start Date: October 1993
  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
  • Preganant 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

Locations
Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari Recruiting
Bari, Italy, 70010
Contact: Vincenzo LISO         v.liso@ematba.uniba.it    
Ospedale Cervello Recruiting
Palermo, Italy, 90146
Contact: Francesco FABBIANO         ffabbiano@libero.it    
A.O Umberto I Recruiting
Roma, Italy
Contact: Franco MANDELLI, MD, PhD         gimema@gimema.it    
Pr. Lo Coco Recruiting
Roma, Italy
Contact: Francesco Lo Coco, Pr         francesco.lo.coco@uniroma2.it    
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
  More Information

No publications provided

Responsible Party: Prof. Franco Mandelli, GIMEMA
ClinicalTrials.gov Identifier: NCT01064557     History of Changes
Other Study ID Numbers: AIDA0493
Study First Received: February 5, 2010
Last Updated: February 5, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acutypromyelocytic 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 May 23, 2013