Back to results

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

Primary Purpose

AIDS-related Lymphoma, HIV Infections

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)

About this trial

This is an interventional treatment trial for AIDS-related Lymphoma focused on measuring AIDS, HIV, Lymphoma, Stem Cell Transplantation, gene-modified Stem Cells, treatment experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Adverse events, ECOG performance status and laboratory safety tests

Secondary Outcome Measures

Remission status (CR or PR)

Any relapse of ARL

level and kinetics of engraftment and level of gene marking

Viral load

CD4 counts

Full Information

NCT ID

NCT00858793

First Posted

March 9, 2009

Last Updated

September 4, 2022

Sponsor

Universitätsklinikum Hamburg-Eppendorf

1. Study Identification

Unique Protocol Identification Number

NCT00858793

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment

Study Start Date

November 28, 2008 (Actual)

Primary Completion Date

August 31, 2016 (Actual)

Study Completion Date

August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AIDS-related Lymphoma, HIV Infections

Keywords

AIDS, HIV, Lymphoma, Stem Cell Transplantation, gene-modified Stem Cells, treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)

Intervention Description

Primary Outcome Measure Information:

Title

Adverse events, ECOG performance status and laboratory safety tests

Time Frame