High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Universitätsklinikum Hamburg-Eppendorf
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female 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) 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
You may not be if
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 \< 40%
* bilirubin \> 2 mg/dl
Severe opportunistic infection
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
Clareo Health | High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
