Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT00858793
Eligibility Criteria:
Inclusion Criteria:
* 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
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 \< 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00858793
Study Brief:
Protocol Section:
NCT00858793