Chronic Graft-versus-host-diseasePhase 2NCT04232397
Anlotinib Treatment in Steroid Depenent/Refractory cGVHD
A Phase 2 study testing Anlotinib in people with Chronic Graft-versus-host-disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a single center, single arm, prospective, phase II clinical study. The main purpose of this study is to evaluate the efficacy and safety of anlotinib in the treatment of steroid dependent/refractory chronic graft-versus-host disease (cGVHD) after allogeneic peripheral blood stem cell transplantation (allo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft-versus-host-disease
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2020to 1 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be diagnosed as hematopoiesis disorders and receiving hematopoietic stem cells transplantation.
- Steroid dependent or refractory classic chronic GVHD disease defined as modified National Institutes of Health criteria(2014) below at any time post-hematopoietic cell transplant(post-HCT)
- Dependent disease, defined as, when glucocorticoid (prednisolone doses greater than or equal to(<=) 0.25mg/kg/day or <=0.5mg/kg every other day(prednisolone doses) due to recurrence or progression of cGVHD manifestations, it is considered as steroid-dependent disease if the lowest tapering dose of the second occasion is equal or higher than the lowest tapering dose of the first occasion
- Refractory disease, defined as, when cGVHD manifestations progress despite the use of a regime containing glucocorticoid (prednisolone at >=1mg/kg/day for at least 1 week) or persist without improvement despite continued treatment with glucocorticoid (prednisolone at >=0.5mg/kg/day or 1mg/kg every other day) for at least 4 weeks.
- Participants must be receiving baseline systemic glucocorticoid therpy for cGVHD at study entry. The dose of steroids must be stable for 14 days prior to starting anlotinib.
- At the time of trial enrollment, participants may be receiving other immunosuppressive therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for 14 days prior to starting anlotinib.
Show all 9Show fewer
- Neutrophil≥1.5×109/L，platelet≥50×109/L
- Karnofsky or Lansky performance status>=60
- Participants should sign the agreement.
Who cannot join
- Known or suspected active acute GVHD.
- Current treatment with a tyrosine kinase inhibitor, purin analogs or other cancer chemotherapy in the 4weeks prior to starting study drug.
- Concomitant use of warfarin or other Vitamin K antogonists.
- Known bleeding disorders or hemophilia.
- Known history of human immunodeficiency virus or active with hepatitis C. virus or hepatitis B virus.
- Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicine or recent infection requiring systemic treatment .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Anlotinib in Subjects With Steroid Depenent/Refractory Chronic Graft Versus Host Disease(cGVHD)
This is a single center, single arm, prospective, phase II clinical study. The main purpose of this study is to evaluate the efficacy and safety of anlotinib in the treatment of steroid dependent/refractory chronic graft-versus-host disease (cGVHD) after allogeneic peripheral blood stem cell transplantation (allo HSCT).
Read the detailed description
Anlotinib 8mg qd po for 6months if no progression in 4weeks or reach PR in 3months
- Conditions
- Chronic Graft-versus-host-disease
- Being tested
- Anlotinib
- 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.
AnlotinibDrug
anlotinib 8mg qd po
| Study group | Role | What they receive |
|---|---|---|
| therapy | Experimental | therapy with 1 arm. Anlotinib 8mg qd po。 Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate as the percentage of participants with response.
Overall response rate is defined as the proportion of subjects who achieved complete response CR or partial response PR. Response criteria are based on NIH cGVHD Response assessment.
Measured: 1year
Secondary outcomes (1)
Duration of Response (DOR)
DOR is defined as the duration of time from the date of initial response
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 Apr 2020
- Primary completion15 Sep 2020
- Study completion1 Mar 2021
Why it stopped: the efficency is not good enough to enroll more patients
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.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- xianmin song, M.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232397
- Sponsor's protocol ID
- SHSYXY-Anlo-cGVHD-2019001
- Status last verified
- Mar 2021
- First submitted
- 15 Jan 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Anlotinib in Subjects With Steroid Depenent/Refractory Chronic Graft Versus Host Disease(cGVHD)
- ClinicalTrials.gov ID
- NCT04232397
- Acronym / sponsor ID
- SHSYXY-Anlo-cGVHD-2019001
- Conditions
- Chronic Graft-versus-host-disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the efficency is not good enough to enroll more patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 Jan 2020 (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 a single center, single arm, prospective, phase II clinical study. The main purpose of this study is to evaluate the efficacy and safety of anlotinib in the treatment of steroid dependent/refractory chronic graft-versus-host disease (cGVHD) after allogeneic peripheral blood stem cell transplantation (allo HSCT).
Detailed description
Anlotinib 8mg qd po for 6months if no progression in 4weeks or reach PR in 3months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy | Experimental | Drug: Anlotinibtherapy with 1 arm. Anlotinib 8mg qd po。 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must be diagnosed as hematopoiesis disorders and receiving hematopoietic stem cells transplantation.
- Steroid dependent or refractory classic chronic GVHD disease defined as modified National Institutes of Health criteria(2014) below at any time post-hematopoietic cell transplant(post-HCT)
- Participants must be receiving baseline systemic glucocorticoid therpy for cGVHD at study entry. The dose of steroids must be stable for 14 days prior to starting anlotinib.
- At the time of trial enrollment, participants may be receiving other immunosuppressive therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for 14 days prior to starting anlotinib.
- Neutrophil≥1.5×109/L，platelet≥50×109/L
Key exclusion criteria (6 listed)
- Known or suspected active acute GVHD.
- Current treatment with a tyrosine kinase inhibitor, purin analogs or other cancer chemotherapy in the 4weeks prior to starting study drug.
- Concomitant use of warfarin or other Vitamin K antogonists.
- Known bleeding disorders or hemophilia.
- Known history of human immunodeficiency virus or active with hepatitis C. virus or hepatitis B virus.
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 |
|---|---|---|
| Anlotinibanlotinib 8mg qd po | Drug | therapy |
Primary outcome
Overall response rate as the percentage of participants with response.
Time frame: 1year
Overall response rate is defined as the proportion of subjects who achieved complete response CR or partial response PR. Response criteria are based on NIH cGVHD Response assessment.
1 secondary outcome
Duration of Response (DOR)
Time frame: 1year
Results and safety
The study was stopped early (reason given: the efficency is not good enough to enroll more patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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.
xianmin song, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 Anlotinib in people with Chronic Graft-versus-host-disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 9 inclusion and 6 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 24 Mar 2021. 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 China. 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 was stopped early (reason given: the efficency is not good enough to enroll more patients). 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?
Overall response rate as the percentage of participants with response. (time frame: 1year). 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 24 Mar 2021.