Finding studies
Finding studies
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Jayastu Senapati, MD
CONTACT
Lead
M.D. Anderson Cancer Center
With
Primary Objectives Cohort 1A To evaluate the safety of ropeginterferon monotherapy and to determine the recommended phase 2 dose (RP2D) of ropeginterferon in patients with R/R MDS/AML with ≥5% blasts Cohort 1B To evaluate the safety and determine the RP2D of ropeginterferon in combination with AZA in patients with newly diagnosed MDS/AML with ≥10% blasts Secondary Objectives To observe and record anti-tumor activity. Although the clinical benefit of ropeginterferon has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Key secondary objective: To assess the efficacy through EFS with AZA+ ropeginterferon separately in the R/R (Cohort 1A) and newly diagnosed patients (Cohort1B) Other secondary objectives (separately for Cohort1A and Cohort1B): 1. CR+CRi (CRc) rates achieved within 4 cycles of therapy 2. Overall response rate (ORR; CRc+ morphologic leukemia free state) 3. Rate of MRD negative CRc by multiparameter flow cytometry (MFC) at 10-4 4. To determine duration of response (CRc and OR) 5. To determine median duration of overall survival (OS) 6. To determine rates of HSCT after study therapy
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted