Reduced Intensity Conditioning (RIC) Regimen and Post-transplant Cyclophosphamide in Haploidentical Bone Marrow Transplantation in in Patients With Poor Prognosis Lymphomas
- Registration Number
- NCT02049580
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis lymphomas.
- Detailed Description
Allogeneic stem cell transplantation (ALLO) is the treatment of choice for many hematological diseases. However, HLA identical donor (sibling or unrelated) is available for 50-60% of patients and alternative donors are needed. Haploidentical donors have been used for many years, mostly after extensive T-cell depletion of peripheral stem cell, to avoid Graft Versus Host Disease (GVHD). Recently, promising data have been reported with haploidentical transplantation using T-replete bone marrow (BM) and high-dose cyclophosphamide (Cy) post-transplantation. However, the conditioning regimen did not contain drugs active against hemopathies, enhancing the relapse risk.
In this study, the investigators want to test the feasibility and efficacy of T-replete BM, infused after a RIC regimen and post-transplantation Cy, in patients with poor prognosis lymphoproliferative diseases.
The RIC regimen consisted of modified regimen used in different studies conducted in Italy on behalf GITMO.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 47
Not provided
- Presence of HLA-matched, related donor (HLA-A, -B, -DRB1)
- Presence of matched unrelated donor (10/10), available on time.
- Pregnancy or breast-feeding.
- Evidence of HIV infection or known HIV positive serology.
- Current uncontrolled bacterial, viral or fungal infection
- Evidence of progression of clinical symptoms or radiologic findings.
- Prior allogeneic hematopoietic stem cell transplant.
- Central Nervous System (CNS) lymphoma localization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RIC regimen Thiotepa Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation. RIC regimen Fludarabine Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation. RIC regimen Cyclophosphamide Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation.
- Primary Outcome Measures
Name Time Method Procedure activity 1 year 1-year Progression Free Survival (PFS) to evaluate the activity of the procedure (taking into account an excess of toxicity). It is assumed that at 1-year a proportion of patients progression free of 20% or lower will be considered to be clinically unworthy, whereas a proportion of 40% or higher will be assumed to be of potential interest.
- Secondary Outcome Measures
Name Time Method Neutrophils recovery 1 year Neutrophils will be measured at different time points of increasing lenght up to 1 year after transplant and then if clinically indicated
Platelets recovery 1 year Platelets will be measured at different time points of increasing lenght up to 1 year after transplant and then if clinically indicated
Incidence of graft failure 1 year Cumulative incidence of acute and chronic GVHD 1 year Incidence of infections 1 year Possible infections will be monitored for a time period of 1 year post-transplantation and then if clinically required
Cumulative incidence of relapse/progression 1 year Treatment related mortality (TRM) 1 year Immunological reconstitution 1 year T, B and NK subsets will be analysed in deep using cytofluorimetry and functional tests.
Trial Locations
- Locations (1)
Istituto Clinico Humanitas
🇮🇹Rozzano, MI, Italy