High-dose chemotherapy with transplantation of gene-modified haematopoietic stem cells for HIV-positive patients with malignant diseases indicating an HSCT
- Conditions
- B21Human immunodeficiency virus [HIV] disease resulting in malignant neoplasms
- Registration Number
- DRKS00000109
- Lead Sponsor
- Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation, Onkologisches Zentrum, Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 10
Female and male patients of any ethnic group aged between 18 and 65 years
-HIV-positive patients with malignant diseases of the blood (NHL, Hodgkin disease, plasmocytoma, acute and chronic leukaemia)
-Patients must receive HAART(HAART should be unchanged since 1 month before inclusion in the study)
-Any of the following conditions:
o congestive heart failure (NYHA > II)
o documented EBV, HBV or HCV infection (only for allogeneic PBSCT)
o creatinine clearance < 60 ml/min
o left ventricular ejection fraction < 40%
o bilirubin > 2 mg/dl
-Not-treated opportunistic infection
-Not-treated CNS involvement of lymphoma
-Isolated CNS relapse of the lymphoma without other evidence of active disease
-More than 10% of bone marrow involved
-Between 2 and 5 x 10^6 autologous CD34+ cells /kg body weight obtained after
leukapheresis and CD34 enrichment
- Women of child-bearing potential not under adequate contraceptive protection
- Women who are pregnant or breast feeding
- Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study
-Participation in another study with an investigational drug within less than one month prior to this study
-Simultaneous participation in a study with an investigational drug
- Presence of any disease likely to require procedures altering the schedule of this study
- Patients who are unable or unwilling to meet the requirements of the protocol
-Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator
-Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication
-Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease
-Patients who will not accept transfusions of blood products
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Parameters (Adverse Events), ECOG performance status and laboratory safety tests(RCR-testing)
- Secondary Outcome Measures
Name Time Method Efficacy parameters CR or PR and any relapse of ARL, level and kinetics of engraftment and level of gene marking, Viral load and CD4 counts