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High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
This study has been completed.
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00858793
First received: March 9, 2009
Last updated: May 26, 2017
Last verified: May 2017
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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: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Primary Effusion Lymphoma
Lymphoma AIDS Related
B-cell 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 ]
Secondary Outcome Measures:
- Remission status (CR or PR) [ Time Frame: five years after transplantation ]
- Any relapse of ARL [ Time Frame: five years after transplantation ]
- level and kinetics of engraftment and level of gene marking [ Time Frame: five years after transplantation ]
- Viral load [ Time Frame: five years after transplantation ]
- CD4 counts [ Time Frame: five years after transplantation ]
| Enrollment: | 5 |
| Actual Study Start Date: | November 28, 2008 |
| Study Completion Date: | August 31, 2016 |
| Primary Completion Date: | August 31, 2016 (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 (Adult) |
| Sexes Eligible for Study: | All |
| 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 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858793
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858793
Locations
| Germany | |
| University Medical Center Hamburg-Eppendorf | |
| Hamburg, Germany, 20246 | |
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
| Principal Investigator: | Nicolaus Kroeger | University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation |
More Information
| Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT00858793 History of Changes |
| Other Study ID Numbers: |
ARL-GT 2005 |
| Study First Received: | March 9, 2009 |
| Last Updated: | May 26, 2017 |
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
|
AIDS HIV Lymphoma |
Stem Cell Transplantation gene-modified Stem Cells treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Lymphoma, AIDS-Related Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
ClinicalTrials.gov processed this record on June 28, 2017