Status:
TERMINATED
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
AIDS-related Lymphoma
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00858793
Start Date
November 28 2008
End Date
August 31 2016
Last Update
September 8 2022
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246