Chronic Graft-versus-host-diseasePhase 2NCT04189432
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
A Phase 2 study testing SCM-CGH in people with Chronic Graft-versus-host-disease, run by SCM Lifescience Co., LTD. at 11 sites in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Graft-versus-host-disease
- What is being tested?
- SCM-CGH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 28 Sep 2016to 30 Sep 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are males or females aged >= 19 years, 40kg to 80kg in weight
- Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as the National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT):
- Refractory disease, defined as, 1) when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at >=1 mg/kg/day for at least 2 weeks) or 2), 3) Persist without improvement despite continued treatment with glucocorticoid (prednisolone at >=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks Dependent disease, defined as, 4), 5) when glucocorticoid (prednisolone doses greater than or equal to [>=] 0.25 milligram per kilogram per day (mg/kg/day)or >=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks.
- Participants must be receiving less than 3 systemic glucocorticoid therapies or other immunosuppressive therapies in addition to glucocorticoids for cGVHD for at least 4 weeks before Screening visit. The dose of steroids or Immunosuppressant must be stable for 14 days(2 weeks) prior to starting SCM-CGH or Placebo.
- Laboratory test sufficiency as follows; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Serum creatinine < 2 x upper limit of normal (ULN)
Who cannot join
- Active acute graft versus host disease (GVHD)
- Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
- Uncontrolled underlying disease such as moderate or severe infections and hemorrhage
- Severe Heart failure (NYHA class III/IV), congestive heart failure or arrhythmia requiring treatment
- History of allogenic hematopoietic stem cell more than once
- Positive reaction of a Penicillin test at screening
Show all 9Show fewer
- History of relapse of causative diseases (ALL, CML, CLL, AML, NHL, multiple myeloma e.t.c.) with hematopoietic stem cell transplantation or diagnosed with secondary malignant diseases after hematopoietic stem cell transplantation
- History of Anti-thymocyte globulin(ATG) for 2 weeks before Screening visit
- History of pulmonary embolism or deep venous thrombosis for 24 weeks before Screening visit
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Kyungpook National University Hospital
Daegu
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Inha University Hospital
Incheon, 22332
Seoul National University Seoul
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
About this study
Official title: A Multicenter, Randomized, Parallel Group, Double-blind, Phase 2 Trial to Evaluate Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).
- Conditions
- Chronic Graft-versus-host-disease
- Being tested
- SCM-CGH, Placebo
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCM-CGHBiological
SCM-CGH will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
PlaceboOther
Placebo will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
| Study group | Role | What they receive |
|---|---|---|
| SCM-CGH | Experimental | * Ingredient: Allogeneic human bone marrow-derived mesenchymal stem cells
* Dose: 1x10^6 cells/Kg Receives: Biological: SCM-CGH |
| Placebo | Placebo comparator | 3 times with 2-week intervals by IV infusion. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve Complete Response (CR) or Partial Response (PR) (i.e. Overall Response Rate [ORR])
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). Response is defined by the National Institutes of Health (NIH) Consensus Development Project Criteria (2014) and must occur, in the absence of new therapy for chronic graft versus host disease (cGVHD) and absence of progression of underlying disease or death. CR: Resolution of all manifestations in each organ or site. PR: Improvement in at least 1 organ or site without progression in any other organ or site. cGVHD Progression: Clinically meaningful worsening in 1 or more organs regardless of improvement in other organs.
Measured: Week 12
Secondary outcomes (5)
Percentage of Participants who Achieve Complete Response (CR) or Partial Response (PR) (i.e. Overall Response Rate [ORR]).
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). Response is defined by the National Institutes of Health (NIH) Consensus Development Project Criteria (2014) and must occur, in the absence of new therapy for chronic graft versus host disease (cGVHD) and absence of progression of underlying disease or death. CR: Resolution of all manifestations in each organ or site. PR: Improvement in at least 1 organ or site without progression in any other organ or site. cGVHD Progression: Clinically meaningful worsening in 1 or more organs regardless of improvement in other organs.
Measured: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Organ-specific Assessments
Percentage of participants with organ-specific assessments is defined as rate of NIH defined CR or PR.
Measured: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Patient-Reported Outcomes
Patient-reported Chronic GVHD-specific Measures are defined by the National Institutes of Health (NIH) Consensus Development Project Criteria (2014).
Measured: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Clinician-Assessed Global Rating/Scale
Global Rating(0~3)/Scale(0~10) of clinician-assessed chronic GVHD-specific measures are defined by the National Institutes of Health (NIH) Consensus Development Project Criteria (2014).
Measured: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Failure-free Survival
Failure-free survival, defined as absence of relapse, death and addition of new treatment, survival free of impairment, or reduction in steroid dosing that do not rely on direct assessment of organ responses.
Measured: Week 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start28 Sep 2016
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-versus-host-diseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter, Randomized, Parallel Group, Double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCM Lifescience Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189432
- Sponsor's protocol ID
- SCM-CGH2001
- Status last verified
- Jun 2023
- First submitted
- 4 Dec 2019
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel Group, Double-blind, Phase 2 Trial to Evaluate Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT04189432
- Acronym / sponsor ID
- SCM-CGH2001
- Conditions
- Chronic Graft-versus-host-disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- SCM Lifescience Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 6 Dec 2019 (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.
The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A Multicenter, Randomized, Parallel Group, Double-blind
| Arm | Type | Receives |
|---|---|---|
| SCM-CGH | Experimental | Biological: SCM-CGH* Ingredient: Allogeneic human bone marrow-derived mesenchymal stem cells * Dose: 1x10^6 cells/Kg |
| Placebo | Placebo comparator | Other: Placebo3 times with 2-week intervals by IV infusion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are males or females aged >= 19 years, 40kg to 80kg in weight
- Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as the National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT):
- Refractory disease, defined as, 1) when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at >=1 mg/kg/day for at least 2 weeks) or 2), 3) Persist without improvement despite continued treatment with glucocorticoid (prednisolone at >=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks Dependent disease, defined as, 4), 5) when glucocorticoid (prednisolone doses greater than or equal to [>=] 0.25 milligram per kilogram per day (mg/kg/day)or >=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks.
- Participants must be receiving less than 3 systemic glucocorticoid therapies or other immunosuppressive therapies in addition to glucocorticoids for cGVHD for at least 4 weeks before Screening visit. The dose of steroids or Immunosuppressant must be stable for 14 days(2 weeks) prior to starting SCM-CGH or Placebo.
- Laboratory test sufficiency as follows; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Serum creatinine < 2 x upper limit of normal (ULN)
Key exclusion criteria (9 listed)
- Active acute graft versus host disease (GVHD)
- Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
- Uncontrolled underlying disease such as moderate or severe infections and hemorrhage
- Severe Heart failure (NYHA class III/IV), congestive heart failure or arrhythmia requiring treatment
- History of allogenic hematopoietic stem cell more than once
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 |
|---|---|---|
| SCM-CGHSCM-CGH will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4). | Biological | SCM-CGH |
| PlaceboPlacebo will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4). | Other | Placebo |
Primary outcome
Percentage of Participants who Achieve Complete Response (CR) or Partial Response (PR) (i.e. Overall Response Rate [ORR])
Time frame: Week 12
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). Response is defined by the National Institutes of Health (NIH) Consensus Development Project Criteria (2014) and must occur, in the absence of new therapy for chronic graft versus host disease (cGVHD) and absence of progression of underlying disease or death. CR: Resolution of all manifestations in each organ or site. PR: Improvement in at least 1 organ or site without progression in any other organ or site. cGVHD Progression: Clinically meaningful worsening in 1 or more organs regardless of improvement in other organs.
5 secondary outcomes
Percentage of Participants who Achieve Complete Response (CR) or Partial Response (PR) (i.e. Overall Response Rate [ORR]).
Time frame: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Organ-specific Assessments
Time frame: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Patient-Reported Outcomes
Time frame: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Clinician-Assessed Global Rating/Scale
Time frame: Week 0, 2, 4, 6, 8, 16, 20, 24 and 48
Failure-free Survival
Time frame: Week 24 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Graft-versus-host-disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCM-CGH in people with Chronic Graft-versus-host-disease, run by SCM Lifescience Co., LTD. at 11 sites in South Korea.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?
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?
Percentage of Participants who Achieve Complete Response (CR) or Partial Response (PR) (i.e. Overall Response Rate [ORR]) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2023.