Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified
Conditions
Interventions
Intervention1: Abatacept and Donor Lymphocyte Infusion: 1) Abatacept as T cell COSBL at 10 mg/kg/dose shall be used on Days-1, +7,+21, +35 in malignant diseases.
2) DLI- Patients shall receive donor
Sponsors
Manashi Chakrabarti Foundation
Eligibility
Inclusion criteria
Inclusion criteria: · First allogeneic transplant. · Age between 2 and 65 years. · Patients must have a related donor that is HLA-matched at least 5 of 10 HLA A, B, C, DRB1, DQB. · Cardiac function: Shortening fraction >25%; ejection fraction >40% · Estimated creatinine clearance greater than 50 mL/minute · Pulmonary function: DLCO >=40% (adjusted for hemoglobin) and FEV1>=70%, oxygen saturation >91% · Liver function: direct (conjugated) bilirubin · No major organ disfunction · Signed informed consent
Exclusion criteria
Exclusion criteria: · Life expectancy less than 6 months · Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) within 1 month prior to conditioning. Patients with febrile illness or suspected minor infection should await clinical resolution prior to starting conditioning. · Pregnant or breastfeeding patients · Patients seropositive for the human immunodeficiency virus (HIV) · Patient with active Hepatitis B or C determined by serology and/or NAAT not on treatment · Active hepatitis, bridging fibrosis or cirrhosis on liver biopsy (biopsy required for patients on chronic transfusion therapy for > 1 year and evidence of iron overload with ferritin >1000 ng/mL) · Patients with suitable 10/10 HLA matched related and unrelated donors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The potential of CTLA4Ig in sparing and/or potentiating NK cell cytotoxicity is an unexplored and yet an exciting possibility in the field of cellular therapy with initial clinical data strongly suggesting a favourable impact of the molecule on NK cell function. This study will help in establishment of the mechanistic pathway underlying this phenomenon. The exploration of the crosstalk between NK cells and monocyte/macrophages might uncover hitherto unknown pathways by which anti-leukemia activity of NK cells is potentiated. Timepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The translational impact of unraveling the interaction between NK cells and monocyte/macrophages on exposure to CTLA4Ig might have a far-reaching impact in the field of cellular therapy, wherein a unique and more importantly, an affordable scalable platform for NK cell-based immunotherapy could be established, both in the context of HCT and without HCT.Timepoint: 24 months | — |
Countries
India
Contacts
Public ContactSuparno Chakrabarti
Manashi Chakrabarti Foundation
Outcome results
None listed