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Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD

NCT ID: NCT06364319

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2028-06-30

Brief Summary

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The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.

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Detailed Description

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Conditions

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cGVHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anti-CD25 rhMAb + traditional therapy

Group Type EXPERIMENTAL

anti-CD25 rhMAb

Intervention Type DRUG

1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49.

Prednisone

Intervention Type DRUG

Maintain pre-screening dose

Ruxolitinib

Intervention Type DRUG

10mg, BID PO

Cyclosporine

Intervention Type DRUG

1.25mg/kg, BID PO/IV, target:150-250ng/ml

traditional therapy

Group Type PLACEBO_COMPARATOR

Prednisone

Intervention Type DRUG

Maintain pre-screening dose

Ruxolitinib

Intervention Type DRUG

10mg, BID PO

Cyclosporine

Intervention Type DRUG

1.25mg/kg, BID PO/IV, target:150-250ng/ml

Interventions

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anti-CD25 rhMAb

1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49.

Intervention Type DRUG

Prednisone

Maintain pre-screening dose

Intervention Type DRUG

Ruxolitinib

10mg, BID PO

Intervention Type DRUG

Cyclosporine

1.25mg/kg, BID PO/IV, target:150-250ng/ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 16 and 65 years
2. Received allogeneic hematopoietic stem cell transplantation
3. Developed chronic GVHD in the liver after transplantation
4. Ineffective prednisone treatment prior to screening
5. Received ≤4 lines of systemic therapy prior to screening
6. After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment

Exclusion Criteria

1. Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
2. No prior treatment with prednisone
3. Overlap syndrome
4. Uncontrolled active infection
5. Organ failure
6. Early progression or recurrence of hematologic diseases
7. Allergy to anti-CD25 rhMAb
8. Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
9. Participated in other clinical studies within one month
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Jun Huang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2024PHD002-001

Identifier Type: -

Identifier Source: org_study_id

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