Acute promyelocitic leukemia
Conditions
Interventions
1.All patients who enter the study must be PCR positive for the PML-RAR*
transcript (or have another retinoid sensitive subtype of APL, i.e. NPM-RAR* or
NuMA-RAR*). However, treatment and study entr
standard
risk (SR) - WBC 10 x 109/l.
3.ATRA is included in induction, consolidation and maintenance therapy.
4.Following one induction course of treatment standard risk patients have 2
consolidatio
Sponsors
Stichting Kinderoncologie Nederland
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARa, NPM1-RARa or NUMA-RARa 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 - 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
Exclusion criteria: - Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARa fusion or lacking PML-RAR*, NPM-RAR* or NuMA-RAR* rearrangement should be withdrawn from the study and treated on an alternative protocol.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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints will be: •Achievement of molecular complete remission (CRm) and reasons for failure •Duration of remission, rates of molecular and frank relapse and deaths in first CR •Overall survival •Toxicity - hematological and non-hematological •Supportive care requirements | — |
Secondary
| Measure | Time frame |
|---|---|
| To decrease long term effects of treatment such as cardiac toxicity | — |
Countries
Netherlands
Outcome results
None listed