High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT

Phase 1

Terminated

• Conditions: HIV Infections; AIDS-related Lymphoma
• Interventions: Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)

• Registration Number: NCT00858793
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-28
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)	-

Primary Outcome Measures

Name	Time	Method
Adverse events, ECOG performance status and laboratory safety tests	five years after transplantation

Secondary Outcome Measures

Name	Time	Method
Remission status (CR or PR)	five years after transplantation
Any relapse of ARL	five years after transplantation
Viral load	five years after transplantation
CD4 counts	five years after transplantation
level and kinetics of engraftment and level of gene marking	five years after transplantation

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany