High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-po… (NCT00858793) | Clinical Trial Compass
TerminatedPhase 1/2
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Stopped: A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment
Germany5 participantsStarted 2008-11-28
Plain-language 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 autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events, ECOG performance status and laboratory safety tests