Multiple SclerosisAutoMS-SweNCT05029206
Hematopoietic Stem Cell Transplantation for Treatment of Multiple Sclerosis in Sweden
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Uppsala University at 8 sites in Sweden.
Trial summary
This is an observational cohort study with retrospective analysis of prospectively collected data. The study cohort is constituted of all patients with relapsing-remitting multiple sclerosis (RRMS) treated with autologous stem cell transplantation (AHSCT) in Sweden from 2004 when the first AHSCT was performed until 31… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Autologous hematopoietic stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 174 participants
- Where
- 8 sitesSweden
- Study dates
- 5 May 2021to 30 Sep 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals with a diagnosis of MS, who was treated with AHSCT in Sweden until December 31st 2019 can be included in this study.
Who may be able to join
- Diagnosis of multiple sclerosis according to the revised McDonald criteria 2017.
- Autologous hematopoietic stem cell transplantation performed for treating multiple sclerosis at a Swedish transplantation center until December 31st 2019.
Who cannot join
- Diagnosis of primary progressive MS or secondary progressive MS according to Lublin et al at the time of transplantation.
- Patient not accepted reporting of data to the EBMT register.
- Not fulfilling requirements of the minimal dataset, se below.
- Definition of minimal dataset
- Data on disease course of multiple sclerosis at the time of transplantation.
- Transplantation and the following in-patient care performed in Sweden.
Show all 12Show fewer
- Date of transplantation.
- Data on drugs used in conditioning.
- At least one follow-up visit performed in Sweden (unless early death before first follow-up visit) including data on:
- Clinical assessment
- The Kurtzke Expanded Disability Status Scores (EDSS)
- Additional note: For a patient to be included in the analysis of treatment effectiveness data on MRI evaluation is needed at least once during follow-up.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Sahlgrenska University Hospital
Gothenburg
Linköping University Hospital
Linköping
Skåne University Hospital
Lund
Örebro University Hospital
Örebro
Danderyd Hospital
Stockholm
Karolinska University Hospital
Stockholm
Umeå University Hospital
Umeå
Uppsala University Hospital
Uppsala
About this study
Official title: Hematopoietic Stem Cell Transplantation for Treatment of Multiple Sclerosis in Sweden - a Register-based Retrospective Observational Study
This is an observational cohort study with retrospective analysis of prospectively collected data. The study cohort is constituted of all patients with relapsing-remitting multiple sclerosis (RRMS) treated with autologous stem cell transplantation (AHSCT) in Sweden from 2004 when the first AHSCT was performed until 31 December 2019. The study aims to describe the effectiveness, safety and patient reported outcomes of AHSCT for MS through real world data. Treatment related mortality will be analyzed from start of mobilization until the end of the study. For other adverse events the data collection will end 3 months post-transplantation. A statistical subgroup comparison of efficacy and safety between the conditioning regimens BEAM-ATG and Cy-ATG will be included within the study.
Read the detailed description
All individuals with a diagnosis of MS, who was treated with AHSCT in Sweden until 31 December 2019 can be included in this study. Patients will be identified through the European Bone and Marrow Transplantation register (EBMT) and the Swedish MS register (SMSreg).
Baseline data will be collected from the SMSreg. Data concerning AHSCT will be collected from local repositories of the EBMT and supplemented by data obtained by reviewing of medical records. This includes data such as doses and names of drugs used for mobilization and conditioning, dates for administration of these drugs, date of hematopoietic stem cell transplantation, date of hematological milestones, occurrence and grading of adverse events during the first three months after the intervention.
Data on clinical outcome after the first three months of the intervention will be collected from SMSreg. Data on vital status will be collected from medical records at the end of study. Any recorded deaths will be analyzed through the medical records to determine if it was treatment-related.
The endpoints will be analysed and described for the whole study cohort. A subgroup analysis comparing the outcome of patients treated with different conditioning regimens (e.g. BEAM-ATG and Cy-ATG) will be included in this study.
- Being tested
- Autologous hematopoietic stem cell transplantation
- Keywords
- Autologous hematopoietic stem cell transplantation, Chemotherapy, Cyclophosphamide, Etoposide, Carmustine, Cytarabine, Melphalan, Antilymphocyte serum
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hematopoietic stem cell transplantationProcedure or surgery
The therapeutic intervention of AHSCT consists of four parts: the mobilization of hematopoietic stem cells (HSC), the harvest of HSC, the ablation (conditioning) of the immune system and the reinfusion of autologous HSCs.
- In Sweden, the mobilization of HSCs has been made by a combination of cyclophosphamide (2 g/m2) and granulocyte-colony-stimulating factor.
- A minimum of 2 × 10^6 CD34+ cells/kg is harvested and cryopreserved. No in vitro manipulation is done to the stem cells.
- Two conditioning regimens have been used in Sweden for ablation. The BEAM-ATG protocol include carmustine (BCNU) 300 mg/m2, etoposide 800 mg/m2, cytarabine arabinoside (ARA-C) 800 mg/m2 and melphalan 140 mg/m2 + rATG or hATG. The Cy-ATG protocol include cyclophosphamide 200 mg/kg + rATG/hATG with 1000 mg Metylprednisolone given day -5 to -1.
- After a minimum of 24 hours after the last administration of chemotherapy have passed, the reinfusion of autologous CD34+ cells is performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
No evidence of disease activity (NEDA)
NEDA is defined as absence of relapses in addition to absence of clinical progression and MRI progression.
Measured: 5 years
Treatment related mortality (TRM)
TRM is defined as death due to any transplantation-related cause other than disease progression.
Measured: Up to 18 years
Secondary outcomes (9)
No evidence of disease activity (NEDA)
NEDA is defined as absence of relapses in addition to absence of clinical progression and MRI progression.
Measured: 3 years and 10 years
MRI event free survival
The appearance of any T2 lesion > 3 mm or gadolinium enhancing lesion in the brain or spinal cord not present on the baseline scan measured from the time of AHSCT.
Measured: At 3, 5 and 10 years
Relapse free survival
A clinical relapse defined as a period of acute worsening of neurological function lasting ≥ 24 hours not attributable to an external cause such as increased body temperature or acute infection, measured from the time of AHSCT.
Measured: At 3, 5 and 10 years
Progression free survival
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS is a composite of disability in eight functional systems.
Baseline EDSS ≤ 5 An increase in EDSS score with at least 1 point from baseline that is sustained between two follow-up visits separated in time by no less than six months.
Baseline EDSS ≥ 5.5 An increase in EDSS score with at least 0.5 points from baseline that is sustained between two follow-up visits separated in time by no less than six months.
Measured: At 3, 5 and 10 years
Annualized relapse rate (ARR)
The number of relapses occurring during a time period divided by the number of years in that time period. E.g. 5 relapses occurring in a time period of 2.5 years equals an ARR of 2 (5/2.5=2), after AHSCT.
Measured: Up to 17 years
Proportion of patients with clinical improvement
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS is a composite of disability in eight functional systems.
Baseline EDSS ≤ 5.5 A decrease in EDSS score with at least 1 point from baseline that is sustained between two follow-up visits separated in time by no less than six months.
Baseline EDSS ≥ 6 A decrease in EDSS score with at least 0.5 points from baseline that is sustained between two follow-up visits separated in time by no less than six months.
Measured: Up to 17 years
EDSS change
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS is a composite of disability in eight functional systems.
Any change in EDSS from baseline to follow-up.
Measured: At 1, 2 and 3 years
Grade 3 serious adverse events the first 100 days
The frequency and of grade 3 serious adverse events within 100 days as defined by the NIH common terminology criteria for adverse events (CTCAE).
Measured: 100 days
Grade 4 serious adverse events the first 100 days
The frequency and of grade 3 serious adverse events within 100 days as defined by the NIH common terminology criteria for adverse events (CTCAE).
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start5 May 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Sahlgrenska University Hospital, Uppsala University Hospital, Skane University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Region Örebro County
- Responsible party
- Sponsor
- Investigators
- Joachim Burman, MD, PhD, Principal investigator, Uppsala UniversityThomas Silfverberg, MD, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029206
- Sponsor's protocol ID
- EPM 2021-01530
- Acronym
- AutoMS-Swe
- Status last verified
- Nov 2023
- First submitted
- 9 Jun 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be made available upon request.
Publications
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
PubMed 11955556Bronnum-Hansen H, Koch-Henriksen N, Stenager E. Trends in survival and cause of death in Danish patients with multiple sclerosis. Brain. 2004 Apr;127(Pt 4):844-50. doi: 10.1093/brain/awh104. Epub 2004 Feb 11.
PubMed 14960501Daumer M, Griffith LM, Meister W, Nash RA, Wolinsky JS. Survival, and time to an advanced disease state or progression, of untreated patients with moderately severe multiple sclerosis in a multicenter observational database: relevance for design of a clinical trial for high dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation. Mult Scler. 2006 Apr;12(2):174-9. doi: 10.1191/135248506ms1256oa.
PubMed 16629420Hader WJ. Disability and survival of multiple sclerosis in Saskatoon, Saskatchewan. Can J Neurol Sci. 2010 Jan;37(1):28-35. doi: 10.1017/s0317167100009616.
PubMed 20169770Skoog B, Runmarker B, Winblad S, Ekholm S, Andersen O. A representative cohort of patients with non-progressive multiple sclerosis at the age of normal life expectancy. Brain. 2012 Mar;135(Pt 3):900-11. doi: 10.1093/brain/awr336.
PubMed 22366800McFarland W, Granville NB, Dameshek W. Autologous bone marrow infusion as an adjunct in therapy of malignant disease. Blood. 1959;14(5):503-521. Blood. 2016 Apr 14;127(15):1839. doi: 10.1182/blood-2016-01-696450.
PubMed 27081092THOMAS ED, LOCHTE HL Jr, CANNON JH, SAHLER OD, FERREBEE JW. Supralethal whole body irradiation and isologous marrow transplantation in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1709-16. doi: 10.1172/JCI103949. No abstract available.
PubMed 13837954Reiffers J, Trouette R, Marit G, Montastruc M, Faberes C, Cony-Makhoul P, David B, Bourdeau MJ, Bilhou-Nabera C, Lacombe F, et al. Autologous blood stem cell transplantation for chronic granulocytic leukaemia in transformation: a report of 47 cases. Br J Haematol. 1991 Mar;77(3):339-45. doi: 10.1111/j.1365-2141.1991.tb08581.x.
PubMed 1672819Philip T, Armitage JO, Spitzer G, Chauvin F, Jagannath S, Cahn JY, Colombat P, Goldstone AH, Gorin NC, Flesh M, et al. High-dose therapy and autologous bone marrow transplantation after failure of conventional chemotherapy in adults with intermediate-grade or high-grade non-Hodgkin's lymphoma. N Engl J Med. 1987 Jun 11;316(24):1493-8. doi: 10.1056/NEJM198706113162401.
PubMed 3295541Burt RK, Cohen BA, Russell E, Spero K, Joshi A, Oyama Y, Karpus WJ, Luo K, Jovanovic B, Traynor A, Karlin K, Stefoski D, Burns WH. Hematopoietic stem cell transplantation for progressive multiple sclerosis: failure of a total body irradiation-based conditioning regimen to prevent disease progression in patients with high disability scores. Blood. 2003 Oct 1;102(7):2373-8. doi: 10.1182/blood-2003-03-0877. Epub 2003 Jul 3.
PubMed 12842989Fagius J, Lundgren J, Oberg G. Early highly aggressive MS successfully treated by hematopoietic stem cell transplantation. Mult Scler. 2009 Feb;15(2):229-37. doi: 10.1177/1352458508096875. Epub 2008 Sep 19.
PubMed 18805841Burt RK, Loh Y, Cohen B, Stefoski D, Balabanov R, Katsamakis G, Oyama Y, Russell EJ, Stern J, Muraro P, Rose J, Testori A, Bucha J, Jovanovic B, Milanetti F, Storek J, Voltarelli JC, Burns WH. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009 Mar;8(3):244-53. doi: 10.1016/S1474-4422(09)70017-1. Epub 2009 Jan 29.
PubMed 19186105Sormani MP, Muraro PA, Schiavetti I, Signori A, Laroni A, Saccardi R, Mancardi GL. Autologous hematopoietic stem cell transplantation in multiple sclerosis: A meta-analysis. Neurology. 2017 May 30;88(22):2115-2122. doi: 10.1212/WNL.0000000000003987. Epub 2017 Apr 28.
PubMed 28455383Sormani MP, Muraro PA, Saccardi R, Mancardi G. NEDA status in highly active MS can be more easily obtained with autologous hematopoietic stem cell transplantation than other drugs. Mult Scler. 2017 Feb;23(2):201-204. doi: 10.1177/1352458516645670. Epub 2016 Jul 11.
PubMed 27207454Rotstein DL, Healy BC, Malik MT, Chitnis T, Weiner HL. Evaluation of no evidence of disease activity in a 7-year longitudinal multiple sclerosis cohort. JAMA Neurol. 2015 Feb;72(2):152-8. doi: 10.1001/jamaneurol.2014.3537.
PubMed 25531931
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Transplantation for Treatment of Multiple Sclerosis in Sweden - a Register-based Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05029206
- Acronym / sponsor ID
- AutoMS-Swe / EPM 2021-01530
- Keywords
- Autologous hematopoietic stem cell transplantation, Chemotherapy, Cyclophosphamide, Etoposide, Carmustine, Cytarabine, Melphalan, Antilymphocyte serum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Sahlgrenska University Hospital, Uppsala University Hospital, Skane University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Region Örebro County
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- 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.
This is an observational cohort study with retrospective analysis of prospectively collected data. The study cohort is constituted of all patients with relapsing-remitting multiple sclerosis (RRMS) treated with autologous stem cell transplantation (AHSCT) in Sweden from 2004 when the first AHSCT was performed until 31 December 2019. The study aims to describe the effectiveness, safety and patient reported outcomes of AHSCT for MS through real world data. Treatment related mortality will be analyzed from start of mobilization until the end of the study. For other adverse events the data collection will end 3 months post-transplantation. A statistical subgroup comparison of efficacy and safety between the conditioning regimens BEAM-ATG and Cy-ATG will be included within the study.
Detailed description
All individuals with a diagnosis of MS, who was treated with AHSCT in Sweden until 31 December 2019 can be included in this study. Patients will be identified through the European Bone and Marrow Transplantation register (EBMT) and the Swedish MS register (SMSreg).
Baseline data will be collected from the SMSreg. Data concerning AHSCT will be collected from local repositories of the EBMT and supplemented by data obtained by reviewing of medical records. This includes data such as doses and names of drugs used for mobilization and conditioning, dates for administration of these drugs, date of hematopoietic stem cell transplantation, date of hematological milestones, occurrence and grading of adverse events during the first three months after the intervention.
Data on clinical outcome after the first three months of the intervention will be collected from SMSreg. Data on vital status will be collected from medical records at the end of study. Any recorded deaths will be analyzed through the medical records to determine if it was treatment-related.
The endpoints will be analysed and described for the whole study cohort. A subgroup analysis comparing the outcome of patients treated with different conditioning regimens (e.g. BEAM-ATG and Cy-ATG) will be included in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals with a diagnosis of MS, who was treated with AHSCT in Sweden until December 31st 2019 can be included in this study.
Key inclusion criteria (2 listed)
- Diagnosis of multiple sclerosis according to the revised McDonald criteria 2017.
- Autologous hematopoietic stem cell transplantation performed for treating multiple sclerosis at a Swedish transplantation center until December 31st 2019.
Key exclusion criteria (12 listed)
- Diagnosis of primary progressive MS or secondary progressive MS according to Lublin et al at the time of transplantation.
- Patient not accepted reporting of data to the EBMT register.
- Not fulfilling requirements of the minimal dataset, se below.
- Definition of minimal dataset
- Data on disease course of multiple sclerosis at the time of transplantation.
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 |
|---|---|---|
| Autologous hematopoietic stem cell transplantationThe therapeutic intervention of AHSCT consists of four parts: the mobilization of hematopoietic stem cells (HSC), the harvest of HSC, the ablation (conditioning) of the immune system and the reinfusion of autologous HSCs. 1. In Sweden, the mobilization of HSCs has been made by a combination of cyclophosphamide (2 g/m2) and granulocyte-colony-stimulating factor. 2. A minimum of 2 × 10^6 CD34+ cells/kg is harvested and cryopreserved. No in vitro manipulation is done to the stem cells. 3. Two conditioning regimens have been used in Sweden for ablation. The BEAM-ATG protocol include carmustine (BCNU) 300 mg/m2, etoposide 800 mg/m2, cytarabine arabinoside (ARA-C) 800 mg/m2 and melphalan 140 mg/m2 + rATG or hATG. The Cy-ATG protocol include cyclophosphamide 200 mg/kg + rATG/hATG with 1000 mg Metylprednisolone given day -5 to -1. 4. After a minimum of 24 hours after the last administration of chemotherapy have passed, the reinfusion of autologous CD34+ cells is performed. | Procedure or surgery | – |
Primary outcome
No evidence of disease activity (NEDA)
Time frame: 5 years
NEDA is defined as absence of relapses in addition to absence of clinical progression and MRI progression.
Treatment related mortality (TRM)
Time frame: Up to 18 years
TRM is defined as death due to any transplantation-related cause other than disease progression.
9 secondary outcomes
No evidence of disease activity (NEDA)
Time frame: 3 years and 10 years
MRI event free survival
Time frame: At 3, 5 and 10 years
Relapse free survival
Time frame: At 3, 5 and 10 years
Progression free survival
Time frame: At 3, 5 and 10 years
Annualized relapse rate (ARR)
Time frame: Up to 17 years
Proportion of patients with clinical improvement
Time frame: Up to 17 years
EDSS change
Time frame: At 1, 2 and 3 years
Grade 3 serious adverse events the first 100 days
Time frame: 100 days
Grade 4 serious adverse events the first 100 days
Time frame: 100 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 22 Nov 2023.
- Background: PubMed 11955556Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
- Background: PubMed 14960501Bronnum-Hansen H, Koch-Henriksen N, Stenager E. Trends in survival and cause of death in Danish patients with multiple sclerosis. Brain. 2004 Apr;127(Pt 4):844-50. doi: 10.1093/brain/awh104. Epub 2004 Feb 11.
- Background: PubMed 16629420Daumer M, Griffith LM, Meister W, Nash RA, Wolinsky JS. Survival, and time to an advanced disease state or progression, of untreated patients with moderately severe multiple sclerosis in a multicenter observational database: relevance for design of a clinical trial for high dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation. Mult Scler. 2006 Apr;12(2):174-9. doi: 10.1191/135248506ms1256oa.
- Background: PubMed 20169770Hader WJ. Disability and survival of multiple sclerosis in Saskatoon, Saskatchewan. Can J Neurol Sci. 2010 Jan;37(1):28-35. doi: 10.1017/s0317167100009616.
- Background: PubMed 22366800Skoog B, Runmarker B, Winblad S, Ekholm S, Andersen O. A representative cohort of patients with non-progressive multiple sclerosis at the age of normal life expectancy. Brain. 2012 Mar;135(Pt 3):900-11. doi: 10.1093/brain/awr336.
- Background: PubMed 27081092McFarland W, Granville NB, Dameshek W. Autologous bone marrow infusion as an adjunct in therapy of malignant disease. Blood. 1959;14(5):503-521. Blood. 2016 Apr 14;127(15):1839. doi: 10.1182/blood-2016-01-696450.
- Background: PubMed 13837954THOMAS ED, LOCHTE HL Jr, CANNON JH, SAHLER OD, FERREBEE JW. Supralethal whole body irradiation and isologous marrow transplantation in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1709-16. doi: 10.1172/JCI103949. No abstract available.
- Background: PubMed 1672819Reiffers J, Trouette R, Marit G, Montastruc M, Faberes C, Cony-Makhoul P, David B, Bourdeau MJ, Bilhou-Nabera C, Lacombe F, et al. Autologous blood stem cell transplantation for chronic granulocytic leukaemia in transformation: a report of 47 cases. Br J Haematol. 1991 Mar;77(3):339-45. doi: 10.1111/j.1365-2141.1991.tb08581.x.
- Background: PubMed 3295541Philip T, Armitage JO, Spitzer G, Chauvin F, Jagannath S, Cahn JY, Colombat P, Goldstone AH, Gorin NC, Flesh M, et al. High-dose therapy and autologous bone marrow transplantation after failure of conventional chemotherapy in adults with intermediate-grade or high-grade non-Hodgkin's lymphoma. N Engl J Med. 1987 Jun 11;316(24):1493-8. doi: 10.1056/NEJM198706113162401.
- Background: PubMed 12842989Burt RK, Cohen BA, Russell E, Spero K, Joshi A, Oyama Y, Karpus WJ, Luo K, Jovanovic B, Traynor A, Karlin K, Stefoski D, Burns WH. Hematopoietic stem cell transplantation for progressive multiple sclerosis: failure of a total body irradiation-based conditioning regimen to prevent disease progression in patients with high disability scores. Blood. 2003 Oct 1;102(7):2373-8. doi: 10.1182/blood-2003-03-0877. Epub 2003 Jul 3.
- Background: PubMed 18805841Fagius J, Lundgren J, Oberg G. Early highly aggressive MS successfully treated by hematopoietic stem cell transplantation. Mult Scler. 2009 Feb;15(2):229-37. doi: 10.1177/1352458508096875. Epub 2008 Sep 19.
- Background: PubMed 19186105Burt RK, Loh Y, Cohen B, Stefoski D, Balabanov R, Katsamakis G, Oyama Y, Russell EJ, Stern J, Muraro P, Rose J, Testori A, Bucha J, Jovanovic B, Milanetti F, Storek J, Voltarelli JC, Burns WH. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009 Mar;8(3):244-53. doi: 10.1016/S1474-4422(09)70017-1. Epub 2009 Jan 29.
- Individual participant dataSharing planned: Yes. Study protocol will be made available upon request.
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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.
Joachim Burman, MD, PhD principal investigator
Uppsala University
Thomas Silfverberg, MD study chair
Uppsala University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Uppsala University at 8 sites in Sweden.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. 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.
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?
No evidence of disease activity (NEDA) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT05029206, which also lists 26 linked publications.
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 22 Nov 2023.