Lymphoma
Conditions
Interventions
Experimental group:7shRNA autologous stem cell transplantation
Sponsors
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 (inclusive) to 60 (inclusive) years, no gender limit; 2. Body mass index (BMI) [weight (kg)/ height^2(m^2)] is 18-25, and body weight should be >=40kg; 3. Meet the Diagnostic Criteria for AIDS and HIV Infection (WS293-2019), and be diagnosed as HIV positive; 4. HIV infection combined with lymphoma, complete or partial response to first-line chemotherapy; or relapse to first-line chemotherapy, complete or partial response to second-line chemotherapy; 5. Age-adjusted IPI 2-3 points; 6. Meet the indications for autologous bone marrow transplantation after clinical evaluation; 7. HIV viral load below 1000 copies/ml; 8. Mental health, patients and their families are willing to participate in the study after they understand the significance, benefits and potential risks of the study.
Exclusion criteria
Exclusion criteria: 1. There are definite active opportunistic infections related to HIV infection that have not been controlled, including fungal infection, sepsis, active tuberculosis, weightlessness, severe diarrhea, active opportunistic infections in the central nervous system; or active hepatitis B, hepatitis C, and other viral infections such as CMV; 2. Cardiac insufficiency (LVEF2mg/dl), hepatic insufficiency (AST/ALT>3 ULN and/or PT <70% unrelated to lymphoma); 3. HAART treatment failure (including at least one NRTI, one NNRTI and two PI) and/or CD4 count < 50/cmm); 4. Pregnant or lactating patients; 5. Any HIV-related encephalitis, any type of mental disorder, epilepsy within the past 12 months; 6. Renal insufficiency (creatinine exceeds the upper limit of normal); 7. Combined with other malignancies ((1) complete remission and more than 5 years after the last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) skin superficial basal cell carcinoma and squamous cell carcinoma excepted ); 8. Participated in other drug trials (except traditional Chinese medicine and cell therapy) within the past three months; 9. Patients who are allergic to G-CSF, plerixafor and other drugs in any regimen; 10. The investigator believes that there is a low possibility of enrollment (such as physical weakness, poor compliance, etc.) or any other factors that are not suitable for entering the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implantation rate;Overall survival;Transplantation related mortality;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral load;7shRNA expression quantity; | — |
Countries
China
Contacts
Public ContactQian Shenxian
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Outcome results
None listed