Clinical trial · Interventional
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIDS-related Lymphoma | AIDS-Related Lymphoma | ONTOLOGY_EXACT | 0.98 |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)
Primary outcomes (1)
- measure
- Adverse events, ECOG performance status and laboratory safety tests
- timeFrame
- five years after transplantation
Secondary outcomes (5)
- measure
- Remission status (CR or PR)
- timeFrame
- five years after transplantation
- measure
- Any relapse of ARL
- timeFrame
- five years after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTYla-Herttuala S. Gene therapy moves forward in 2010. Mol Ther. 2011 Feb;19(2):219-20. doi: 10.1038/mt.2010.307. No abstract available. PMID 21289631