NCI Community Oncology Research Program - Protocol Summary
ECOG-ACRIN EA9131 - "A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Leukemia Clinical Trial
CANCER TYPE: Acute
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT03253848
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UPDATED ON 08/16/2018 (20:47:54)
To evaluate if the proposed patient care strategy, that includes use of simplified Guidelines along with APL expert support, decreases the one-month induction mortality rate from 30% to under 15%. DCP-001 Eligible
Patient care strategy:
- Treating physician must call APL expert at any Lead Site to discuss algorithm and treatment plan.
- It is preferred the APL expert for the catchment area is contacted first. It is suggested that the call be placed as soon as a diagnosis is suspected.
- 7 investigators at the lead sites have been identified as APL experts.
- Registration/consent must not delay starting treatment.
- Registration is done only if treating physician calls expert within 3 days of starting APL directed treatment.
- Consent patient after APL diagnosis is confirmed.
- Patient is treated locally at NCORP community center according to suggested treatment plan from APL expert.
- Follow treatment guidelines according to Appendix I. If necessary, deviations from guidelines may occur per discretion of treating physician and consulting physician.
- All patients ≥ 18 years of age who are confirmed to have a diagnosis of APL, which is defined as:
- Positive t(15:17) by FISH, OR
- Positive t(15:17) by conventional karyotype, OR
- Positive PML/RAR alpha by PCR
- Patients must accept treatment and supportive care guidelines.
- Referrals must be made as early as possible by treating physician (provider) but no later than 3 calendar days after ATRA or APL directed therapy is initiated. Consent can be obtained up until day 7 after initiating APL Directed Therapy.
- Co-management can be started as soon as referral is made including weekends. The Physician at the NCORP community facility should make every effort to call the APL expert at the first suspicion of APL.