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

Sponsored by:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00858793

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 I Phase II

MedlinePlus related topics: AIDS Lymphoma

U.S. FDA Resources

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

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
A: Experimental	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.

Arms

Assigned Interventions

A: Experimental

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:	University Medical Center Hamburg-Eppendorf ( Prof. Dr. Dr. A. R. Zander )
Study ID Numbers:	ARL-GT 2005
Study First Received:	March 9, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00858793 History of Changes
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

Study placed in the following topic categories:

Lymphoma, AIDS-related
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Virus Diseases
Lymphoma, B-Cell
Lymphatic Diseases

B-cell Lymphomas
Lymphoma, AIDS-Related
HIV Infections
Sexually Transmitted Diseases
Primary Effusion Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Lymphoma, B-Cell
Virus Diseases

Lymphatic Diseases
Neoplasms
Lymphoma, AIDS-Related
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009