Overview

Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Associazione Italiana Ematologia Oncologia Pediatrica
Treatments:
Tretinoin
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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fusion or lacking PML-RARα, NPM-RARα or NuMA-RARα rearrangement should be withdrawn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).