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

NCT ID: NCT00858793

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-28
• Study Completion Date: 2016-08-31

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.

Conditions

AIDS-related Lymphoma; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolaus Kroeger

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

Yla-Herttuala S. Gene therapy moves forward in 2010. Mol Ther. 2011 Feb;19(2):219-20. doi: 10.1038/mt.2010.307. No abstract available.

Reference Type: RESULT

PMID: 21289631 (View on PubMed)

Related Links

https://www.esgct.eu/home/Previous%20Congresses/2010_Milan/Milan_2010_abstracts.pdf

page 1435; abstract 109

Other Identifiers

ARL-GT 2005

Identifier Type: -

Identifier Source: org_study_id