Burkitt's lymphoma in HIV-positive patients. MedDRA version: 14.1 Level: PT Classification code 10006595 Term: Burkitt's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: METHYLPREDNISOLONE ACETATE
CAS Number: 53361
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histology of Burkitt's lymphoma according to the 2008 WHO classification. 2. HIV sero-positivity. 3. Age >/= 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. CNS parenchymal involvement [patients with meningeal dissemination (lymphomatous meningosis) are eligible]. 2. Absolute neutrophil count 1,5 ULN (Burkitt unrelated). 4. SGOT and/or SGTP > 2,5 ULN (Burkitt unrelated). 5. Bilirubin > 2 ULN (Burkitt unrelated). 6. Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance. 7. Significant cardiac disease or acute myocardial infarction in the last 12 months. 8. Severe active infection (HBV and/or HCV co-infection does not constitute exclusion criteria in this trial). 9. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate the feasibility and tolerability of the investigational intensive chemotherapy in HIV+ patients with Burkitt's lymphoma. 2. To evaluate the feasibility and tolerability of the consolidation phase followed by BEAM conditioning and autologous stem cell transplantation in HIV+ patients with Burkitt's lymphoma in partial response after induction chemotherapy. 3. To evaluate the feasibility and tolerability of intensification with high-dose sequential chemotherapy in HIV+ patients with Burkitt's lymphoma in stable disease after or in progressive disease during or after induction chemotherapy. 4. To evaluate the activity of the whole investigational intensive chemotherapy program in HIV+ patients with Burkitt's lymphoma. 5. To define 2-year Disease-free Survival (DFS), Progression-free Survival (PFS) and Overall Survival (OS).;Main Objective: To evaluate the activity in terms of complete remission rate (defined according to Cheson's criteria) at the end of the induction phase of the investigational intensive chemotherapy in HIV+ patients with Burkitt's lymphoma.;Primary end point(s): Activity of the induction phase of the investigational intensive chemotherapy in terms of complete remission rate (according to Cheson's criteria).;Timepoint(s) of evaluation of this end point: At the end of the induction phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade >/= 4 adverse events. 2. Feasibility and tolerability of the consolidation phase followed by BEAM conditioning and autologous stem cell transplantation in terms of prevalence of grade >/= 4 adverse events. 3. Feasibility and tolerability of intensification phase in terms of prevalence of grade >/= 4 adverse events. 4. Activity of the whole investigational program in terms of complete remission rate. 5. Disease-free Survival (DFS), Progression-free Survival (PFS) and Overall Survival (OS) at 2 years.;Timepoint(s) of evaluation of this end point: 1. At the end of the whole investigational program. 2. At the end of the consolidation phase. 3. At the end of the intensification phase. 4. At the end of the whole investigational program. 5. At 2 years. | — |
Countries
Italy
Contacts
Public ContactOncologia, U. D. Tumori Linfoidi
Fondazione Centro San Raffaele del Monte Tabor
Outcome results
None listed