Patients with lymphomas (any histology) relapsed after high dose chemotherapy and in complete remission or partial remission after the last CT line MedDRA version: 14.1 Level: PT Classification code 10003908 Term: B-cell small lymphocytic lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspec
Conditions
Interventions
Product Name: thiotepa
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: THIOTEPA
CAS Number: 52-24-4
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PATIENT-RELATED CRITERIA 1. Age 18-70 years old 2. Karnofsky performance score = 80% 3. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and DQB1 loci. A minimum match of 5/10 is required. An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant. 4. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1 5. Patients with lymphomas (any histology) relapsed after high dose chemotherapy and in complete remission or partial remission after the last CT line. a. Hodgkin’s lymphoma. Patients refractory to at least 2 CT lines, and included in tandem auto-allo program. b. Diffuse large B cell lymphoma Refractory to second line salvage chemotherapy (patients in partial remission, stable disease or progressive). These patients have to be in partial remission or complete remission after last CT line, including high dose chemotherapy (auto-allo program). Transformed low grade lymphomas c. Peripheral T cell lymphoma Patients failing to achieve a complete remission after first line CT. d. Low grade lymphomas (follicular and non follicular) Patients refractory to first R-CT line. Patients failing at least 2 lines CT - The duration of last remission should be =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Presence of HLA-matched, related donor (HLA-A, -B, -DRB1) 2. Presence of matched unrelated donor (10/10), available on time. 3. Pregnancy or breast-feeding. 4. Evidence of HIV infection or known HIV positive serology. 5. Current uncontrolled bacterial, viral or fungal infection 6. Evidence of progression of clinical symptoms or radiologic findings. 7. Prior allogeneic hematopoietic stem cell transplant. 8. CNS lymphoma localization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity, taking into account an excess of toxicity, of the procedure of T-replete BM infused after a reduced intensity conditioning (RIC) regimen and post-transplantation Cy, in patients with poor prognosis lymphoproliferative diseases. ;Secondary Objective: To further evaluate the efficacy and safety of the procedure;Primary end point(s): 1-year progression free survival (PFS) ;Timepoint(s) of evaluation of this end point: 1 year from the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Neutrophil and platelet recovery • Incidence of graft failure • Cumulative incidence of acute and chronic GVHD • Incidence of infections • Cumulative incidence of relapse/progression • Treatment related mortality (TRM) • Immunological reconstitution ;Timepoint(s) of evaluation of this end point: controls with different frequencies in the interval between transplantation and the 1-year follow-up visit, according to clinical practice | — |
Countries
Italy
Contacts
Public ContactHumanitas Cancer Center
ISTITUTO CLINICO HUMANITAS
Outcome results
None listed