Hematological MalignanciesPhase 2NCT00504803
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease
A Phase 2 study testing Mesenchymal stem cell infusion in people with Hematological Malignancies, run by University of Liege at 1 site in Belgium.
Trial summary
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Mesenchymal stem cell infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2006to Dec 2010
- Phase
- Phase 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 Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
V.1. Patients
V.1.1. Diseases
Hematological malignancies confirmed histologically and not rapidly progressing:
- AML in CR;
- ALL in CR;
- CML unresponsive/intolerant to Imatinib but not in blast crisis;
- Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis;
- MDS with < 5% blasts;
- Multiple myeloma;
- CLL;
- Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
- Hodgkin's disease.
V.1.2. Clinical situations
- Theoretical indication for a standard allo-transplant, but not feasible because:
- Age > 55 yrs;
- Unacceptable end organ performance;
- Patient's refusal.
- Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.
V.1.3. Other inclusion criteria
- Male or female; fertile female patients must use a reliable contraception method;
- Age < 75 yrs.
- Informed consent given by patient or his/her guardian if of minor age.
V.1.4. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- HIV positive;
- Terminal organ failure, except for renal failure (dialysis acceptable);
- Uncontrolled infection, arrhythmia or hypertension;
- Previous radiation therapy precluding the use of 2 Gy TBI;
- HLA-identical donor.
V.2. PBSC donors
V.2.1. Inclusion criteria
- Related to the recipient (sibling, parent or child) or unrelated;
- Male or female;
- Weight > 15 Kg (because of leukapheresis);
- Fulfills generally accepted criteria for allogeneic PBSC donation;
- Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.
V.2.2. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- HIV positive;
- Unable to undergo leukapheresis because of poor vein access or other reasons.
V.2.3. HLA matching
Related or unrelated donors who have 1-2 HLA mismatches, as either :
- One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
- One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
- One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1
V.3. Cord blood unit
Banked cord blood units will be used if they fulfill the following criteria:
- No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)
- > 2.5 x 107 TNC/kg
- Standard validation by FACT/Netcord criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study
- Conditions
- Hematological Malignancies
- Being tested
- Mesenchymal stem cell infusion
- Keywords
- HCT, nonmyeloablative, mesenchymal stem cells, GVHD
- Medical subject headings
- Hematologic Neoplasms, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell infusionProcedure or surgery
Also called Mesenchymal stem cells
Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MSC co-infusion with either HLA-mismatched PBSC or cord blood Receives: Procedure: Mesenchymal stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-100 incidence of non-relapse mortality
Measured: 100 days
Secondary outcomes (1)
1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2010
- Study completionDec 2010
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 Hematological MalignanciesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Beguin, University of Liege
- Investigators
- Frederic Baron, MD, PhD, Principal investigator, CHU-ULgYves Beguin, MD, PhD, Principal investigator, CHU-ULgChantal Lechanteur, PhD, Study chair, CHU-ULgEtienne Baudoux, MD, Study chair, CHU-ULgEvelyne Willems, MD, Study chair, CHU-ULg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504803
- Sponsor's protocol ID
- TJB0601
- Status last verified
- Sep 2011
- First submitted
- 19 Jul 2007
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Baron F, Lechanteur C, Willems E, Bruck F, Baudoux E, Seidel L, Vanbellinghen JF, Hafraoui K, Lejeune M, Gothot A, Fillet G, Beguin Y. Cotransplantation of mesenchymal stem cells might prevent death from graft-versus-host disease (GVHD) without abrogating graft-versus-tumor effects after HLA-mismatched allogeneic transplantation following nonmyeloablative conditioning. Biol Blood Marrow Transplant. 2010 Jun;16(6):838-47. doi: 10.1016/j.bbmt.2010.01.011. Epub 2010 Jan 28.
PubMed 20109568
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study
- ClinicalTrials.gov ID
- NCT00504803
- Acronym / sponsor ID
- TJB0601
- Conditions
- Hematological Malignancies
- Keywords
- HCT, nonmyeloablative, mesenchymal stem cells, GVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jul 2007 (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.
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Mesenchymal stem cell infusionMSC co-infusion with either HLA-mismatched PBSC or cord blood |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Mesenchymal stem cell infusionAlso: Mesenchymal stem cellsInfusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion. | Procedure or surgery | 1 |
Primary outcome
Day-100 incidence of non-relapse mortality
Time frame: 100 days
1 secondary outcome
1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Derived from this study: PubMed 20109568Baron F, Lechanteur C, Willems E, Bruck F, Baudoux E, Seidel L, Vanbellinghen JF, Hafraoui K, Lejeune M, Gothot A, Fillet G, Beguin Y. Cotransplantation of mesenchymal stem cells might prevent death from graft-versus-host disease (GVHD) without abrogating graft-versus-tumor effects after HLA-mismatched allogeneic transplantation following nonmyeloablative conditioning. Biol Blood Marrow Transplant. 2010 Jun;16(6):838-47. doi: 10.1016/j.bbmt.2010.01.011. Epub 2010 Jan 28.
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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.
Frederic Baron, MD, PhD principal investigator
CHU-ULg
Yves Beguin, MD, PhD principal investigator
CHU-ULg
Chantal Lechanteur, PhD study chair
CHU-ULg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cell infusion in people with Hematological Malignancies, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 2 Sep 2011. 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 Belgium. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Day-100 incidence of non-relapse mortality (time frame: 100 days). 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 NCT00504803, 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 2 Sep 2011.