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High-Dose Chemotherapy With Transplantation of Gene-Modified Stem Cells for High-Risk AIDS-Related Lymphoma

This study is currently recruiting participants.
Verified March 2009 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00858793
First received: March 9, 2009
Last updated: April 7, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
AIDS-Related Lymphoma
HIV Infections
 Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-Dose Chemotherapy With Transplantation of Gene-Modified Stem Cells for High-Risk AIDS-Related Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Lymphoma
U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Adverse events, ECOG performance status and laboratory safety tests [ Time Frame: five years after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: October 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 NHL 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 < 50%
    • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858793

Contacts
Contact: Axel R Zander, Prof. Dr. Dr. +49-40-7410-54850 zander@uke.uni-hamburg.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Axel R Zander, Prof. Dr. Dr.     +49-40-7410-54850     zander@uke.uni-hamburg.de    
Contact: Marion Heinzelmann, R. N.     +49-40-7410-54188     mheinzel@uke.uni-hamburg.de    
Principal Investigator: Axel R Zander, Prof. Dr. Dr.            
Sub-Investigator: Jan van Lunzen, PD Dr.            
Sub-Investigator: Alex Zoufaly, Dr.            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Prof. Dr. Dr. A. R. Zander, University Medical Center Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00858793     History of Changes
Other Study ID Numbers: ARL-GT 2005
Study First Received: March 9, 2009
Last Updated: April 7, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on May 23, 2013