AIDA 2000 Guidelines

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Recruiting

CT.gov ID

NCT01064570

Collaborator

(none)

600

Enrollment

Locations

200

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Promyelocytic Leukemia	Drug: all-trans retinoic acid (ATRA)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Guidelines for Treatment of Acute Promyelocytic Leukemia

Study Start Date :

May 1, 2000

Outcome Measures

Primary Outcome Measures

Treatment-related toxicity event rate during the ATRA-including consolidation treatment [At the end of the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Unità Operativa Ematologia 1 - Università degli Studi di Bari	Bari	Italy	70010
2	Div. di Ematologia IRCCS Policlinico S. Matteo	Pavia	Italy	27100
3	A.O Umberto I	Roma	Italy