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the efficency is not good enough to enroll more patients
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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).
Anlotinib 8mg qd po for 6months if no progression in 4weeks or reach PR in 3months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapy | Experimental | therapy with 1 arm. Anlotinib 8mg qd po。 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | anlotinib 8mg qd po |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the duration of time from the date of initial response | 1year |
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Inclusion Criteria:
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
Karnofsky or Lansky performance status>=60
Participants should sign the agreement.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xianmin song, M.D. | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Department | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |