Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Graft-versus-host-disease
• Intervention / Treatment: Drug: Anlotinib

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Hematology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	DOR is defined as the duration of time from the date of initial response	1year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: SHSYXY-Anlo-cGVHD-2019001

Drug and device information, study documents

• 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