Health Condition 1: null- Hematopoietic stem cell transplantation
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Pharmacokinetics: Blood samples after the first single dose would be drawn through an indwelling venous access at time 0.0 (pre drug administration) and 0.5, 1.0
Sponsors
Emcure Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The subjects will be selected for study participation, if they meet the following criteria: 1. Class 3 patients with Thalassemia major and patients > 18 years of age with other haematological disorders requiring allogeneic HSCT. 2. Availability of appropriate HLA identical donor 3. Willful written informed consent as per regulatory requirements 4. Performance status 0 â?? 2 (karnofsky performance status >80%) 5. Agreed on adequate contraception in subjects of child bearing age
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study, if they meet any of the following criteria: 1. Contraindications as per summary of product characteristics 2. H/o of psychiatric illness or malignant involvement of CNS 3. For Class 3 Thalassemia patients - Total Bilirubin 2 x ULN, SGOT & SGPT 5 x ULN is allowed, For other Haematological disorders - Total Bilirubin 2 x ULN, SGOT & SGPT 3 x ULN is allowed. 4. H/o of renal dysfunction (creatinine clearance less than 60ml/min 5. H/o of cardiac and other metabolic disorders 6. H/o respiratory dysfunction 7. HIV positive or active hepatitis or active infectious disease 8. Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics assessment Primary endpoint: i) Safety of infusion and short term toxicity profile if any up to day 30 post HSCT ii) Treosulfan pharmacokinetics among these patients and its comparison with existing published data.Timepoint: Blood samples after the first single dose would be drawn through an indwelling venous access at time 0.0 (pre drug administration) and 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 24.0 hr after the start of treosulfan infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. The status of engraftment â?? as assessed by blood counts and chimerism analysis by VNTRs at day 30 post HSCTTimepoint: 0 | — |
Countries
India
Contacts
Public ContactDr Alok Srivastava
Christian Medical College
Outcome results
None listed