Graft Versus Host Disease. Graft-versus-host disease
Conditions
Interventions
Intervention group: Intervention group: Treg preparation and injection is performed after Haploidentical HSCT. Treg suspended in 50 ml of 5% albumin solution is injected intravenously (central vein) o
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age 18–70 (70–75 if Co-Morbidity =2); HLA-A, B, DRB1 matched. Donors for iTreg must undergo Immobilized apheresis Diagnosis of Acute leukemia (morphologic recovery, limited blasts, no relapse cytogenetic markers), Burkitt lymphoma CR2+, NK-cell malignancies, CML (chronic phase with TKI failure or T315I), MDS high risk (RAEB-1/2, severe cytopenia, <5% blasts; chemo if =5%), CMML (~5% blasts, preferably <20%), chemo-sensitive large-cell lymphoma, Hodgkin, multiple myeloma, CLL/SLL, marginal zone or follicular lymphoma (progression =12 months, debulk if bulky), lymphoplasmacytic, mantle cell, prolymphocytic leukemia (post-initial therapy, chemo-sensitive, autologous transplant =12 months or multi-agent chemo =3 months). Performance Status Karnofsky =70% Organ Function: Kidney: Cr =2.0 mg/dL or eGFR =40; Liver: ALT/AST/Alk-P =5×ULN, T. bilirubin =2.5 (except Gilbert/hemolysis); Lung: DLCO, FEV1, FVC =40%, no O2; Heart: no uncontrolled CHF/arrhythmia, LVEF =40% No pregnancy/lactation; contraception agreement no investigational drugs within 14 days ability/willingness to sign informed consent
Exclusion criteria
Exclusion criteria: Uncontrolled bacterial or viral infections, or known HIV, hepatitis B, or C infection Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan not evaluated by bronchoscopy. Infiltrations attributed to infection must be stable and improving after 1 week of appropriate therapy (4 weeks for suspected or proven fungal infections) Known sensitivity to one or more study agents Active autoimmune disease requiring systemic immunosuppressive therapy Less than 3 months of myeloablative conditioning for autologous transplantation (if applicable) Previous allogeneic transplantation Large cell lymphoma, Mantle cell lymphoma, and Hodgkin disease progressing on salvage therapy Active central nervous system malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects following regulatory T cell infusion in patients. Timepoint: From the time of injection of the prescribed dose 28 days, 6 months and one year after injection. Method of measurement: Patient statements and medical examinations in patient visits to bone marrow transplantation clinic for follow-up, Safety criteria are based on CTCAE (Common Terminology Criteria for Adverse Events) for side effects.;Response to GVHD treatment following regulatory T cell infusion. Timepoint: From the time of injection of the prescribed dose until 28 days, 56 days and 100 days after injection. Method of measurement: Regular patient check-ups at the bone marrow transplant clinic for monitoring and based on modified Glucksberg criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| GVL effect associated with reduction/no recurrence of underlying disease. Timepoint: Day 28, 6 months, and one year after regulatory T cell injection. Method of measurement: Clinical examination during regular visits to the bone marrow transplant clinic and examination of bone marrow morphology and standard CR criteria.;Event free survival. Timepoint: three and six and 12 months after injection. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.;Progression free survival. Timepoint: Three and six and 12 months after injection. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.;Overall survival. Timepoint: Three and six and 12 months after injection. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Roshandel
Shahid Beheshti University of Medical Sciences
Outcome results
None listed