Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
Conditions
Interventions
Intervention1: Standardized Withaferin-A: SWA will be started from Day +1 to Day +90 in addition to the standard GvHD prophylaxis backbone of calcineurin inhibitor and methotrexate. Following standard
Sponsors
ACTREC, Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.ECOG performance score of 0 or 1 2.Adequate liver function (Total serum bilirubin less than twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 fold higher than laboratory upper normal limits) 3.Adequate renal function (creatinine clearance more than 50 ml per min) 4.Adequate cardiac function (LVEF more than 40 percent) 5.Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. 6.Signed, written informed consent
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or contraindications against Withaferin A. 2.Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. 3.Any medical or psychiatric illness which precludes the participant from giving informed consent 4.Pregnancy, lactation, or inadequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 1.Safety and tolerability of oral SWA in patients undergoing hematopoietic stem cell transplant (by assessment of more than 3toxicity by CTCAE version 5 and PRO-CTCAE version 1. 2.To study the clinical pharmacokinetics of standardized Withaferin-A and establish recommended Phase II dose (RP2D). Phase 2 1.To determine the activity of WA in GvHD prophylaxis. (by assessing the cumulative incidence of clinically significant (Grade 2 to 4) aGvHD at Day 100) Timepoint: Phase 1 90 days Phase 2 100 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the cumulative incidence of severe aGvHD (grade 3-4) at Day 100 and Day 180. 2.To evaluate the GvHD free- and relapse free- survival (GRFS) rate at 1 year post transplant. 3.To study the incidence of chronic GvHD at 1 year post transplant. 4.To study engraftment kinetics. 5.To study the non-relapse mortality at 1 year post transplant. 6.To study the overall survival (OS) at 1 year post transplant. Timepoint: at Day 100 and Day 180, 1 year | — |
Countries
India
Contacts
Public ContactDr Akanksha Chichra
Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed