NCT01064570

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

3 active sites

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

May 1, 2000

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

First QC Date

February 5, 2010

Last Update Submit

October 12, 2020

Conditions

Acute Promyelocytic Leukemia

Keywords

Acute Promyelocytic LeukemiaAPL

Outcome Measures

Primary Outcomes (1)

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

    At the end of the study

Secondary Outcomes (5)

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

    At the end of the study

  • The rates of molecular remission, after consolidation, in each risk group

    At the end of the study

  • Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications

    At the end of the study

  • The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group

    At the end of the study

  • The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse

    At the end of the study

Interventions

all-trans retinoic acid (ATRA)DRUG

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unità Operativa Ematologia 1 - Università degli Studi di Bari

Bari, 70010, Italy

RECRUITING

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

RECRUITING

A.O Umberto I

Roma, Italy

RECRUITING

Related Publications (2)

  • Breccia M, Mazzarella L, Bagnardi V, Disalvatore D, Loglisci G, Cimino G, Testi AM, Avvisati G, Petti MC, Minotti C, Latagliata R, Foa R, Pelicci PG, Lo-Coco F. Increased BMI correlates with higher risk of disease relapse and differentiation syndrome in patients with acute promyelocytic leukemia treated with the AIDA protocols. Blood. 2012 Jan 5;119(1):49-54. doi: 10.1182/blood-2011-07-369595. Epub 2011 Nov 2.

    PMID: 22049518BACKGROUND

  • Lo-Coco F, Avvisati G, Vignetti M, Breccia M, Gallo E, Rambaldi A, Paoloni F, Fioritoni G, Ferrara F, Specchia G, Cimino G, Diverio D, Borlenghi E, Martinelli G, Di Raimondo F, Di Bona E, Fazi P, Peta A, Bosi A, Carella AM, Fabbiano F, Pogliani EM, Petti MC, Amadori S, Mandelli F; Italian GIMEMA Cooperative Group. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group. Blood. 2010 Oct 28;116(17):3171-9. doi: 10.1182/blood-2010-03-276196. Epub 2010 Jul 19.

    PMID: 20644121RESULT

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 Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

May 1, 2000

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

IT(3)