Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Hematologic Malignancies MedDRA version: 6.1 Level: PT Classification code 10028228
Conditions
Interventions
Trade Name: CELLCEPT
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Mycophenolic acid
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 30-
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in any complete remission, Aplastic Anemia, Paroxsymal Nocturnal Hemoglobinuria, Myelodysplastic and Chronic Myeloproliferative Syndromes, Multiple Myeloma. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator. -Elderly patients age > 50 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission. -Uncontrolled CNS involvement with disease -Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment -Females who are pregnant -Organ dysfunction defined as follows: Cardiac function: ejection fraction 3 mg/dl and/or transaminases >4x the upper limit of normal Renal: creatinine clearance <50 cc/min (24 hour urine collection) -Karnofsky performance score < 60% -Patients with poorly controlled hypertension on multiple antihypertensives -Documented fungal disease that is progressive despite treatment -Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis -Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A Phase II study evaluating the incidence and severity of acute GVHD following allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning.;Secondary Objective: -To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism. -To evaluate the incidence and extent of chronic GVHD. -To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells. -To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate.;Primary end point(s): A Phase II study evaluating the incidence and severity of acute GVHD following allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning. | — |
Countries
Italy
Outcome results
None listed