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

This study has suspended participant recruitment.
(A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment)
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00858793
First received: March 9, 2009
Last updated: May 12, 2015
Last verified: May 2015

March 9, 2009
May 12, 2015
October 2008
December 2016   (final data collection date for primary outcome measure)
Adverse events, ECOG performance status and laboratory safety tests [ Time Frame: five years after transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00858793 on ClinicalTrials.gov Archive Site
  • Remission status (CR or PR) [ Time Frame: five years after transplantation ] [ Designated as safety issue: No ]
  • Any relapse of ARL [ Time Frame: five years after transplantation ] [ Designated as safety issue: No ]
  • level and kinetics of engraftment and level of gene marking [ Time Frame: five years after transplantation ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: five years after transplantation ] [ Designated as safety issue: No ]
  • CD4 counts [ Time Frame: five years after transplantation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • AIDS-related Lymphoma
  • HIV Infections
Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)
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.
Experimental: A
Intervention: Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
October 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00858793
ARL-GT 2005
Yes
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Nicolaus Kroeger University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Universitätsklinikum Hamburg-Eppendorf
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP