HIGH-DOSE SEQUENTIAL CHEMOTHERAPY AND RITUXIMAB (R-HDS) IN HIV+ PATIENTS WITH NON-HODGKIN LYMPHOMA (NHL) REFRACTORY OR RELAPSED AFTER 1st LINE TREATMENT - ND

Phase 1

• Conditions: HIV+ PATIENTS WITH NON-HODGKIN LYMPHOMA (NHL) REFRACTORY OR RELAPSED AFTER 1st LINE TREATMENT; Level: PTClassification code 10029547

• Registration Number: EUCTR2007-005506-42-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-10
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

age < 18 years; -criteria not in line with inclusion criteria; -partecipation to pther trials; inability to give consenst

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified