High-Dose Chemotherapy With Transplantation of Gene-Modified Stem Cells for High-Risk AIDS-Related Lymphoma
Inclusion Criteria:
- Male and female patients of any ethnic group aged between 18 and 65 years
- HIV-positive patients with NHL who failed to achieve complete remission (CR) after
standard-dose first-line chemotherapy or had a chemosensitive relapse after an
initial CR
- Patients must receive HAART
Exclusion Criteria:
- Any of the following conditions:
- congestive heart failure (NYHA > II)
- documented EBV, HBV or HCV infection (only for allogeneic PBSCT)
- creatinine clearance < 60 ml/min
- left ventricular ejection fraction < 50%
- 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 with lymphoma
- Between 2 and 5 10^6 autologous CD34+ cells/kg BW 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 product 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 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 have previously been admitted to this study
- Patients who will not accept transfusions of blood products