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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 consists of donor lymphocytes infusion, harvested by apheresis the day before the day planned for infusion (or up to -7 days) as outpatient basis in the Day Hospital using a cell separator.
The mDLIs preparation will be performed using a CliniMACS® (Miltenyi). A CD45RA-depletion Product LineTM from Miltenyi, including disposable reagents and devices, will be used.
The planned number of mDLI is 3.
Stopping infusion rules:
If GvHD ≥ Grade 2 or relapse occurs, mDLIs will not be administered at any time and patient will be permanently discontinued from treatment.
If any severe adverse event (SAE) occurs after the first mDLI, the administration of mDLI will be interrupted for a maximum of 6 weeks until event resolution. If the SAE does not resolve after 6 weeks from last mDLI infusion, patient will be permanently discontinued. At any time, the experimental treatment may be stopped according to clinical judgement or patient's willing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mDLI infusion | Experimental | The planned number of mDLI is 3.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified donor lymphocytes infusion (mDLI) | Biological | The planned number of mDLI is 3.
|
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the efficacy of CD45RA-depleted haplo-DLIs (mDLIs) in the setting of patients receiving haplo-HSCT and PT-Cy, in terms of incidence of viral infections in the post-transplant period | The primary endpoint is the rate of viral infections at day +100 after haplo-BMT. | 100 days |
| to evaluate the impact of the modified DLIs on the occurrence of GvHD | acute and chronic GvHD incidence | 1 year |
| to evaluate the impact of the modified DLIs on relapse (graft-versus-tumor effect) | relapse rate | 1 year |
| to evaluate the impact of the modified DLIs on other types of infections; | 100-day cumulative incidence of other type of infections | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Rozzano | MI | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36469095 | Derived | van Beek JJP, Puccio S, Di Vito C, De Paoli F, Zaghi E, Calvi M, Scarpa A, Peano C, Basso G, Cibella J, De Philippis C, Sarina B, Timofeeva I, Capizzuto R, Mannina D, Mineri R, Mariotti J, Crocchiolo R, Santoro A, Castagna L, Bramanti S, Mavilio D, Lugli E. Selected memory T cells infused post-haploidentical hematopoietic stem cell transplantation persist and hyperexpand. Blood Adv. 2023 Jul 25;7(14):3458-3468. doi: 10.1182/bloodadvances.2022007735. |
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|
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D007239 | Infections |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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