A Phase 3, Open-Label, Multicenter, Randomized Study of SKLB1028 Versus Salvage Chemotherapy in Patients With FLT3-mutated Acute Myeloid Leukemia Refractory to or Relapsed After First-line Treatment(ALIVE)

Who is this study for? Patients with FLT3-mutated acute myeloid leukemia refractory to or relapsed after first-line treatment
What treatments are being studied? SKLB1028
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a randomized,multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia(AML)compared to salvage chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients volunteered to participate in this study and signed the informed consent form.

• Age≥18 years old, no gender limitation.

• Patient has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) as determined by pathological and morphological results, according to World Health Organization (WHO) 2016 classification.

• Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).

∙ Refractory to first-line AML treatment is defined as: the patient did not achieve complete remission/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp) under initial therapy. A patient eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction therapy in the standard dose for the selected induction regimen. A patient not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this patient as per investigator's assessment.

‣ Early relapse after first-line AML therapy is defined as: the patients achieved CR/CRi/CRp after first-line treatment, and relapsed within 6 months with hematological relapse.

‣ Advanced relapse after first-line AML therapy is defined as: the patients achieved CR/CRi/CRp after first-line treatment and relapsed after 6 months with hematological relapse;

• Patient is positive for FLT3 mutation in bone marrow or whole blood.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

• Patient is eligible for pre-selected salvage chemotherapy according to investigator assessment.

• Patient must meet the following criteria as indicated on the clinical laboratory tests:

∙ Serum aspartate aminotransferase and alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN);

‣ Serum total bilirubin ≤ 1.5 x ULN;

‣ Serum creatinine ≤ 3.0 x ULN or an estimated glomerular filtration rate of \> 30 mL/min.

• Patient is suitable for oral administration of the study drug.

⁃ Female or male patient of childbearing age agree to take effective non-drug contraception from the date of signing an informed consent to 180 days after the last dose and will not donate sperm or eggs.

Locations
Other Locations
China
West China hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Ting Liu, Chief doctor
liuting@scu.edu.cn
+862885422364
Time Frame
Start Date: 2021-03-24
Estimated Completion Date: 2025-12
Participants
Target number of participants: 315
Treatments
Experimental: SKLB1028
Subjects will receive 150 mg orally twice daily (BID) in continuous 28-day cycles
Active_comparator: Salvage Chemotherapy
Chemotherapy will be given in 28-day cycles. Subjects on low-dose cytarabine (LoDAC) will receive 10 to 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injections for 7 to 14 days.~Subjects on azacitidine will receive 75 mg/m\^2 daily by SC or IV, for 5 to 7 days.~Subjects on homoharringtonine (HHT), cytarabine and aclarubicin (HAA) will receive 2 mg/m\^2 of HHT by IV, for 7 days (day 1 to 7) (or HHT 2 mg/m\^2, twice daily, day 1 to 3); 100\~200 mg/m\^2 of cytarabine by IV for 7 days (day 1\~7) and 20 mg/d of aclarubicin by IV for 7 days (day 1 to 7).~Subjects on fludarabine, cytarabine and granulocyte colony-stimulating factor (G-CSF) (FLAG) will receive 30 mg/m\^2 of fludarabine daily by IV for 5 days (day 2 to 6), 1000\~2000 mg/m2 of cytarabine daily by IV for 5 days (day 2 to 6), and 300 g/m\^2 of G-CSF daily by SC or IV for 5 days (days 1 to 5). After completion of chemotherapy, G-CSF will be administered continually until ANC\>0.5 x 10\^9 / L.
Related Therapeutic Areas
Sponsors
Leads: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

This content was sourced from clinicaltrials.gov