Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
Conditions
Interventions
Intervention1: Cyclophosphamide.: Post-transplant Immunosuppression:
GvHD prophylaxis regimen will consist of two doses of cyclophosphamide on D+3 and D+4 at 25mg/kg/day (that is half of the usual sta
Sponsors
ACTREC Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.ECOG performance score of 0 or 1
Exclusion criteria
Exclusion criteria: 1.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. 2.Any medical or psychiatric illness which precludes the participant from giving informed consent. 3.Organ function criteria: Serious organ dysfunctions: a.Serious cardiac dysfunction: Left ventricular ejection fraction less than 45 percent; no uncontrolled arrhythmias or symptomatic cardiac disease. b.Serious pulmonary organ dysfunction: Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) equal to or less than 50 percent of predicted (corrected for haemoglobin). c.Serious renal dysfunction: Measured serum creatinine clearance equal to or less 60 mL per min. d.Serious Hepatic dysfunction: Total serum bilirubin more than twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the cumulative incidence of severe (Grade 3-4) aGvHDTimepoint: at day 100 Post Transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the cumulative incidence of clinically significant (Grade2-4) aGvHD at Day 100 and Day 180. 2.To evaluate the cumulative incidence of severe (Grade 3-4) aGvHD at Day 180. 3.To evaluate the GvHD and relapse free survival (GRFS) rate at 1 year post transplant (GRFS events will include grade III or IV acute GVHD, or extensive chronic GVHD or disease relapse). 4.To study the incidence of chronic GvHD at 1 year post transplant. 5.To study the engraftment kinetics 6.Safety Regimen Related Toxicity [Time Frame 100 Days Post Transplant] 7.To study the transplant related mortality (TRM) at 1 year post transplant. 8.To study the overall survival (OS) at 1 year post transplant.Timepoint: Day 100, Day 180 and 1 year post transplant | — |
Countries
India
Contacts
Public ContactDr Sachin Punatar
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed