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

September 4, 2022 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, ECOG performance status and laboratory safety tests
Time Frame: five years after transplantation
five years after transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Nicolaus Kroeger, University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2008

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 4, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARL-GT 2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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