HIV+ PATIENTS WITH NON-HODGKIN LYMPHOMA (NHL) REFRACTORY OR RELAPSED AFTER 1st LINE TREATMENT Level: PT Classification code 10029547
Conditions
Interventions
Trade Name: DECADRON
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Dexamethasone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of diffuse large B-cell or follicular (Gr. III) CD20+ lymphoma or primary effusion lymphoma (PEL), primary resistant or relapsing after conventional chemotherapy (CHOP or CHOP-like regimen) 2. HIV infection with CD4+ count > 200 cells/dL and negative HIV-RNA 3. Age 19-65 years 4. ECOG performance status 0-3 (if > 60 years old = ECOG performance status 0-2 5. Adequate bone marrow (PLT ³100000 mm3, Hb ³9 gr/dL, ANC ³2000 mm3), renal (creatinine clearance ³60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin ≤3 mg/dL, AST/ALT and GGT ≤3 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement) 6. Absence of symptomatic coronary artery disease, cardiac arhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) 7. No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin and of other cancers without evidence of disease at least from 5 years and Kaposi sarcoma in an inactive phase 8. No concurrent opportunistic diseases: a. HBV chronic hepathitis does NOT represent an exclusion criteria, only if the infection is controlled by adequate antiviral therapy (lamivudine) and HBV-DNA must be negative b. HCV chronic hepathitis does NOT represent an exclusion criteria, unless the above mentioned hepatic function criteria are not satisfied 9. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 10. Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation 11. No treatment with other experimental drugs within the 6 weeks previous to enrolment 12. Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age < 18 years; -criteria not in line with inclusion criteria; -partecipation to pther trials; inability to give consenst
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: incidence of infectious complications and mortality after R-HDS in HIV+ patients;Secondary Objective: 1. efficacy of R-HDS in overall disease response rate and lymphoma-free survival 2. intention-to-treat analysis of overall feasibility of R-HDS in all HIV+ candidate patients 3. viral and immunological follow-up during R-HDS treatment 4. PK of HAART during chemotherapy with high dose ARA-C and VP-16;Primary end point(s): incidence of infectious complications and mortality after R-HDS in HIV+ patients | — |
Countries
Italy
Outcome results
None listed