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NCT04069208
IA14 Induction in Young Acute Myeloid Leukemia
Phase 2 trial testing Idarubicin and cytarabine induction in Acute Myeloid Leukemia in 42 participants. Status unknown.
31 October 2021
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 3 September 2019 |
| Primary completion | 31 October 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Idarubicin and cytarabine induction — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 60, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute myeloid leukemia (AML) is a clinically and biologically heterogeneous disease characterized by the clonal expansion of undifferentiated myeloid precursors. Although induction chemotherapy with cytarabine and daunorubicin/Idarubicin, typically called "7+3", has not changed for several decades, the best dosage of anthracycline is still unknown. Several prospective trials have demonstrated that intense dosage of anthracycline improved complete remission (CR) and overall survival (OS). Idarubicin 12mg/m2 (IA12) has been shown to be equal to dose intense daunorubicin (90 mg/m2 ) for achieving CR. Dose-intense daunorubicin 90 mg/m2 (DA90) has been shown to improve CR compared to standard dose daunorubucin 45mg/m2 in newly diagnosed AML patients. In our previous study, CR rate of induction with daunorubicin 60 mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 was about 67%. Benefit of intensification seems limited to the patients without adverse cytogenetics. Wheher ultra high dose idarubicin 14mg/m2 (IA14) could further improve CR rate, give patients with adverse cytogenetics a chance to do allo-stem cell transplantation? This phase 2, prospective, single-center study is designed to evaluate the efficacy and safety of induction with idarubicin 14mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 in young newly diagnosed AML patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04069208
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04069208 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking Union Medical College Hospital
- Last refreshed: 8 June 2021
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