AIDS-related LymphomaPhase 1/2NCT00858793
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
A Phase 1/2 study testing PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) in people with AIDS-related Lymphoma and HIV Infections, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS-related Lymphoma, HIV Infections
- What is being tested?
- PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2008to 31 Aug 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)
- Keywords
- AIDS, HIV, Lymphoma, Stem Cell Transplantation, gene-modified Stem Cells, treatment experienced
- Medical subject headings
- Lymphoma, AIDS-Related, HIV Infections, Acquired Immunodeficiency Syndrome, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, ECOG performance status and laboratory safety tests
Measured: five years after transplantation
Secondary outcomes (5)
Remission status (CR or PR)
Measured: five years after transplantation
Any relapse of ARL
Measured: five years after transplantation
level and kinetics of engraftment and level of gene marking
Measured: five years after transplantation
Viral load
Measured: five years after transplantation
CD4 counts
Measured: five years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study start28 Nov 2008
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Why it stopped: A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AIDS-related LymphomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaus Kroeger, Principal investigator, University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858793
- Sponsor's protocol ID
- ARL-GT 2005
- Status last verified
- Sep 2022
- First submitted
- 9 Mar 2009
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21289631
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
- ClinicalTrials.gov ID
- NCT00858793
- Acronym / sponsor ID
- ARL-GT 2005
- Conditions
- AIDS-related Lymphoma, HIV Infections
- Keywords
- AIDS, HIV, Lymphoma, Stem Cell Transplantation, gene-modified Stem Cells, treatment experienced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 28 Nov 2008 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- Any of the following conditions:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | A |
Primary outcome
Adverse events, ECOG performance status and laboratory safety tests
Time frame: five years after transplantation
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Results publication: PubMed 21289631Yla-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.
- page 1435; abstract 109Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaus Kroeger principal investigator
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) in people with AIDS-related Lymphoma and HIV Infections, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, ECOG performance status and laboratory safety tests (time frame: five years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.