Trial document





This trial has been registered retrospectively.
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  DRKS00000109

Trial Description

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Title

High-dose chemotherapy with transplantation of gene-modified haematopoietic stem cells for HIV-positive patients with malignant diseases indicating an HSCT

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This study intends to offer HIV-positive patients requiring a haematopoietic stem cell transplantation an additional gene-therapy treatment against HIV.

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Brief Summary in Scientific Language

High-dose chemotherapy followed by the transplantation of hematopoietic stem/progenitor cells protected with an antiviral gene in HIV-positive patients with malignant diseases has two major goals: 1. The intensified chemotherapy with stem cell rescue aims to radically eliminate malignant cells and to induce continuous complete remission (CCR) in the patient. 2. The transfer of a highly effective antiviral gene (M87o) into the stem cells aims to reconstitute a competent immune system that includes an ideally complete T-cell repertoire and monocytes that are protected against HIV-infection.

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Organizational Data

  •   DRKS00000109
  •   2009/04/27
  •   2009/03/09
  •   yes
  •   Approved
  •   Bearb-Nr.: 2693, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   2005-003026-26 
  •   NCT00858793  (ClinicalTrials.gov)
  •   203/01 
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Health Condition or Problem studied

  •   B21 -  Human immunodeficiency virus [HIV] disease resulting in malignant neoplasms
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Interventions/Observational Groups

  •   High-dose chemotherapy with transplantation of autologous or allogeneic gene-modified stem cells
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
  •   [---]*
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Primary Outcome

Safety Parameters (Adverse Events), ECOG performance status and laboratory safety tests(RCR-testing)

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Secondary Outcome

Efficacy parameters CR or PR and any relapse of ARL, level and kinetics of engraftment and level of gene marking, Viral load and CD4 counts

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/12/02
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- Female and male 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)
-Patients must receive HAART(HAART should be unchanged since 1 month before inclusion in the study)

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Exclusion Criteria

-Any of the following conditions:
o congestive heart failure (NYHA > II)
o documented EBV, HBV or HCV infection (only for allogeneic PBSCT)
o creatinine clearance < 60 ml/min
o left ventricular ejection fraction < 40%
o bilirubin > 2 mg/dl
-Not-treated opportunistic infection
-Not-treated CNS involvement of lymphoma
-Isolated CNS relapse of the lymphoma without other evidence of active disease
-More than 10% of bone marrow involved
-Between 2 and 5 x 10^6 autologous CD34+ cells /kg body weight 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 drug 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 this study
- Patients who are unable or unwilling to meet the requirements 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 will not accept transfusions of blood products

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Addresses

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    • Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation, Onkologisches Zentrum, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med.   Nicolaus  Kröger 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. rer. nat.  Boris  Fehse 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med.  Nicolaus  Kröger 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Germany
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Status

  •   Recruiting suspended on temporary hold
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.