Status:
COMPLETED
Feasibility and Efficacy of Modified Donor Lymphocytes Infusion (CD45RA Negative Selected) After Haploidentical Transplantation With Post-transplantation Cyclophosphamide in Patients With Hematological Malignancies (ONC-2016-002).
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Bone Marrow Transplant Infection
Bone Marrow Transplant Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Interventional non-randomized trial. The duration of study will be 47 months. After haploidentical transplantation, patients without complications, mainly a GVHD ≥ grade 2, will receive mDLI. mDLI co...
Eligibility Criteria
Inclusion
- Written, signed informed consent;
- Adult patients aged ≥18 years;
- Patients who underwent haploidentical transplantation with PT-Cy for haematological diseases since no more than 56 days;
- Patient who received myeloablative conditioning regimen, reduced intensity conditioning regimens, or non-myeloablative conditioning regimens;
- Availability of haploidentical donor (defined as those with ≥ 2 differences within one HLA haplotype) who agree to donate peripheral blood cells by leukapheresis and able to donate the day before the day planned for infusion (or up to - 7 days);
- GVHD/HVG prophylaxis consists in Cyclophosphamide: 50 mg/kg/day, day +3 and +4, Cyclosporine A: 3 mg/kg/day from day +5 to day +100, with tapering in 2 months Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35.
Exclusion
- Presence of grade 2-4 acute GVHD;
- Uncontrolled bacterial, viral or fungal infection;
- Aplasia defined as ANC less than 500/L;
- Evidence of disease progression after transplantation;
- Current participation in another clinical study.
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04687982
Start Date
November 13 2018
End Date
January 8 2020
Last Update
December 29 2020
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089