Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04232397
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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 HSCT).

Condition or Disease	Intervention/Treatment	Phase
Chronic Graft-versus-host-disease	Drug: Anlotinib	Phase 2

Detailed Description

Anlotinib 8mg qd po for 6months if no progression in 4weeks or reach PR in 3months

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Anlotinib in Subjects With Steroid Depenent/Refractory Chronic Graft Versus Host Disease(cGVHD)
• Actual Study Start Date: Apr 10, 2020
• Actual Primary Completion Date: Sep 15, 2020
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: therapy therapy with 1 arm. Anlotinib 8mg qd po。	Drug: Anlotinib; anlotinib 8mg qd po

Outcome Measures

Primary Outcome Measures

1. Overall response rate as the percentage of participants with response. [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.

Secondary Outcome Measures

1. Duration of Response (DOR) [1year]

   DOR is defined as the duration of time from the date of initial response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participants must be diagnosed as hematopoiesis disorders and receiving hematopoietic stem cells transplantation.

2. 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)

3. 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

4. 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.

5. 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.

6. 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.

7. Neutrophil≥1.5×109/L，platelet≥50×109/L

8. Karnofsky or Lansky performance status>=60

9. Participants should sign the agreement.

Exclusion Criteria:

1. Known or suspected active acute GVHD.

2. Current treatment with a tyrosine kinase inhibitor, purin analogs or other cancer chemotherapy in the 4weeks prior to starting study drug.

3. Concomitant use of warfarin or other Vitamin K antogonists.

4. Known bleeding disorders or hemophilia.

5. Known history of human immunodeficiency virus or active with hepatitis C. virus or hepatitis B virus.

6. Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicine or recent infection requiring systemic treatment .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology Department	Shanghai	Shanghai	China	200080

Sponsors and Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

• Principal Investigator: xianmin song, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xianmin Song, MD, professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04232397
• Other Study ID Numbers: SHSYXY-Anlo-cGVHD-2019001
• First Posted: Jan 18, 2020
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Mar 24, 2021