Health Condition 1: C96Z- Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: Cohort-1:
Injection Arsenic trioxide (ATO) Injection Artesunate (ART): Injection ATO 10 mg IV x 10 days
Injection artesunate (ART) starting at 2.4mg/kg/day x 7 days
Intervention2: Cohor
Sponsors
Indian council of medical research
Eligibility
Inclusion criteria
Inclusion criteria: Subjects age = 18 years of age (adults) Subjects must be diagnosed with Primary Myelofibrosis according to the 2008 World Health Organization criteria (Table 2 in Tefferi and Vardiman, 2008) irrespective of JAK2 mutation status. Subjects with an ECOG performance status of 0, 1, or 2. Subjects with peripheral blood blast count of less than 10% at the Screening and Baseline visits.
Exclusion criteria
Exclusion criteria: Subjects with a life expectancy of less than six months. Subjects in whom MF disease is well controlled with current therapy. Females who are pregnant or are currently breastfeeding. Subjects of childbearing potential who are unwilling to take appropriate precautions (from Screening through Follow-up) to avoid becoming pregnant or fathering a child. Subjects with inadequate bone marrow reserve as demonstrated by: a. Absolute neutrophil count (ANC) that is less than 500 b. Platelet count less than 30,000 without the assistance of growth factors, thrombopoietic factors, or platelet transfusions. Subjects must not have received growth factors for at least one month before receiving the first dose of the study drug. 6. Subjects with inadequate liver or renal function as demonstrated by: a. Direct bilirubin above 2 X upper limit of laboratory normal (ULN). (NOTE: Direct bilirubin will only be determined if total bilirubin is above 2.0 x ULN). b. Alanine aminotransferase (ALT) above 2.5x upper limit of laboratory normal (ULN).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving above 35% reduction in spleen volume from baseline to Week 24 as measured by ultrasound (or CT scan in applicable subjects)Timepoint: Assessed at 3 months 6 months and at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of maintenance of a above 35% reduction from baseline in spleen volume among subjects receiving intervention. Proportion of subjects who have above 50% reduction in total symptom score from baseline to Week 24 as measured by the Modified MFSAF. • Reduction in JAK2V617F allelic burden in those who are positive at diagnosis • Overall survival.Timepoint: Assessed at 3 months, 6 months and 12 months | — |
Countries
India
Contacts
Public ContactVikram Mathews
Christian Medical College Vellore Ranipet campus
Outcome results
None listed