Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

NCT ID: NCT04232397

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2021-03-01

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

Conditions

Chronic Graft-versus-host-disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapy

therapy with 1 arm. Anlotinib 8mg qd po。

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

anlotinib 8mg qd po

Interventions

Anlotinib

anlotinib 8mg qd po

Intervention Type: DRUG

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xianmin Song, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xianmin song, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Hematology Department

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHSYXY-Anlo-cGVHD-2019001

Identifier Type: -

Identifier Source: org_study_id