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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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ClinicalTrials.gov Identifier: NCT00858793
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease Intervention/treatment Phase
AIDS-related Lymphoma HIV Infections Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Actual Study Start Date : November 28, 2008
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A 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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events, ECOG performance status and laboratory safety tests [ Time Frame: five years after transplantation ]

Secondary Outcome Measures :
  1. Remission status (CR or PR) [ Time Frame: five years after transplantation ]
  2. Any relapse of ARL [ Time Frame: five years after transplantation ]
  3. level and kinetics of engraftment and level of gene marking [ Time Frame: five years after transplantation ]
  4. Viral load [ Time Frame: five years after transplantation ]
  5. CD4 counts [ Time Frame: five years after transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858793


Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Nicolaus Kroeger University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00858793     History of Changes
Other Study ID Numbers: ARL-GT 2005
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
AIDS
HIV
Lymphoma
 Stem Cell Transplantation
gene-modified Stem Cells
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lymphoma, AIDS-Related
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders