TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

Summary

This multicenter randomized, open-label study aim to compare the efficacy and safety of TPO-RAs combining anti-CD 20 monoclonal antibody with TPO-RAs in China pediatric ITP patients .This study will be conducted in persistent or chronic pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

DRUG

TPO-RAs

After enrollment, all subjects receive TPO-RAs treatment. The initial dose of eltrombopag, hetrombopag and avatrombopag administration were the same as described in arm description. Complete blood count including platelet count was done once a week. The dose of TPO-RAs was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the TPO-RAs will stop until the platelet count \<100×10\^9/L.

DRUG

TPO-RAs combining anti-CD 20 monoclonal antibody

After enrollment, all subjects receive TPO-RAs treatment. The initial dose of eltrombopag, hetrombopag and avatrombopag administration were the same as described in arm description.The dose of TPO-RAs was adjusted according to the subject platelet count during the period from week 1 to week 24. Subjects in TPO-RAs combining anti-CD 20 monoclonal antibody treatment group received single dose infusion of Rituximab 375 mg/m2 within 14 days after enrollment. Subjects weighing less than 30kg will be given Rituximab 100 mg once a week for four times. Ortuzumab at 1000mg/ dose is also recommended for subjects weighing 45kg or greater. Ps.Participants in the TPO-RAs monotherapy group who have platelet count \< 20×10\^9/L or significant skin and mucosal bleeding at the end of 12 weeks of treatment will be given a single dose of Rituximab 375mg/m2 or Ortuzumab at 1000mg/ dose if weighing 45kg or greater.

Sponsors & Collaborators

• Beijing Children's Hospital

  collaborator OTHER

• Tianjin People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Tianjin Medical University Second Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Principal Investigators

• Lei Zhang, M.D.,Ph.D · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-23

Primary Completion

2025-05-14

Completion

2025-11-14

Countries

• China

Study Locations