Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

Phase 2

Terminated

• Conditions: Chronic Graft-versus-host-disease
• Interventions: Drug: Anlotinib

• Registration Number: NCT04232397
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-04-10
• Primary Completion: 2020-09-15
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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)

   1. 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
   2. 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.

3. 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.

4. 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.

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

6. Karnofsky or Lansky performance status>=60

7. 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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy	Anlotinib	therapy with 1 arm. Anlotinib 8mg qd po。

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Duration of Response (DOR)	1year	DOR is defined as the duration of time from the date of initial response

Trial Locations

Locations (1)

Hematology Department; 🇨🇳 Shanghai, Shanghai, China