NCT01226303

Brief Summary

This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e. NPM-RAR-alpha, NuMA-RARalpha) and less than 21 years of age (for AIEOP, see appendix A).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 26, 2017

Status Verified

July 1, 2016

Enrollment Period

8.4 years

First QC Date

October 20, 2010

Last Update Submit

January 25, 2017

Conditions

Acute Promyelocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • • to conduct an international pediatric study for APL based on the GIMEMA-AIEOP/AIDA 93 protocol (the study from the Italian GIMEMA -AIEOP group which has produced the best results in children with APL to date), with optimal outcome and less toxicity

    • to conduct an international pediatric study for APL based on the GIMEMA-AIEOP/AIDA 93 protocol (the study from the Italian GIMEMA -AIEOP group which has produced the best results in children with APL to date), with optimal outcome and less toxicity

    5 years

Secondary Outcomes (1)

  • • To monitor cardiotoxicity by echocardiography

    5 years

Study Arms (2)

standard risk

EXPERIMENTAL

are defined as those patients with a WBC less than 10x10 9 /L at presentation

Drug: ATRA

high risk

ACTIVE COMPARATOR

are defined as those patients whose highest treatment WBC is equal to or greater than 10x10 9 /L at presentation

Drug: ATRA + IDA

Interventions

ATRADRUG

see the protocol

standard risk
ATRA + IDADRUG

see the protocol

high risk

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARα, NPM1-RARα or NUMA-RARα fusion. Whilst this study is only for ATRA-sensitive APL, APL is a hematological emergency and ATRA should be commenced as soon as the diagnosis is suspected. Study entry should not wait until the diagnosis of APL has been confirmed molecularly or cytogenetically
  • Less than 21 years of age at initial diagnosis (for AIEOP, see appendix A)
  • Considered suitable for anthracycline-based chemotherapy
  • Written informed consent available
  • Females of childbearing age must have a negative pregnancy test and subsequently must attempt to avoid pregnancy

You may not qualify if:

  • Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARα fusion or lacking PML-RARα, NPM-RARα or NuMA-RARα rearrangement should be withdrawn from the study and treated on an alternative protocol.
  • Refractory/relapsed APL (the guidelines in this protocol for that subgroup are intended for patients treated from initial diagnosis according to this protocol)
  • Concurrent active malignancy
  • Pregnant or lactating
  • Physician and patient/guardian think that intensive chemotherapy is not an appropriate treatment option
  • Patients who have received alternative chemotherapy for 7 days or longer without ATRA for any reason (either APL not initially suspected or ATRA not available).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di Biotecnologie Cellulari ed Ematologia

Roma, 00161, Italy

RECRUITING

Related Links

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Annamaria Testi, Dr

    Associazione Italiana Ematologia Oncologia Pediatrica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Testi, PI

CONTACT

06.857951testi@bce.uniroma1.it

Andrea Pession, Prof

CONTACT

051.-6364443andrea.pession@unibo.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

January 1, 2009

Primary Completion

June 1, 2017

Study Completion

December 1, 2018

Last Updated

January 26, 2017

Record last verified: 2016-07

Locations

IT(1)