Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

NCT04232397 | Terminated Phase 2 DMC

• 1 other identifier: SHSYXY-Anlo-cGVHD-2019001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Graft-versus-host-disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of Response (DOR)

  1year

Study Arms (1)

therapy

EXPERIMENTAL

therapy with 1 arm. Anlotinib 8mg qd po。

Drug: Anlotinib

Interventions

Anlotinib DRUG

anlotinib 8mg qd po

therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Neutrophil≥1.5×109/L，platelet≥50×109/L
• Karnofsky or Lansky performance status\>=60
• Participants should sign the agreement.

You may not qualify if:

• 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 .

Sponsors & Collaborators

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

Study Sites (1)

Hematology Department

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• xianmin song, M.D.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: April 10, 2020
• Primary Completion: September 15, 2020
• Study Completion: March 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

CN (1)