NCT05682131

Brief Summary

In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%. A number of in vitro studies have shown that arsenic trioxide (ATO) can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
53mo left

Started Sep 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Sep 2022Sep 2030

Study Start

First participant enrolled

September 27, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2030

Last Updated

January 12, 2023

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

January 2, 2023

Last Update Submit

January 10, 2023

Conditions

Arsenic TrioxideChildhood ALL

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    Complete response rate after induction treatment in two groups

    from diagnosis, an average of 7 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Oral placebo was added to conventional chemotherapy

Combination Product: Conventional chemotherapy

Experimental Group

EXPERIMENTAL

Oral RIF was added to conventional chemotherapy

Drug: Realgar Indigo naturalis formulaCombination Product: Conventional chemotherapy

Interventions

Realgar Indigo naturalis formulaDRUG

Realgar Indigo naturalis formula was used in the induction, consolidation and intensive treatment of patients in intermediate or high risk

Also known as: RIF
Experimental Group
Conventional chemotherapyCOMBINATION_PRODUCT

conventional chemotherapy

Control groupExperimental Group

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • B or T cell type;
  • the first recurrence;
  • the risk stratification was medium or high risk.

You may not qualify if:

  • mature B cell leukemia;
  • acute mixed phenotype leukemia;
  • patients with positive BCR/ABL fusion gene;
  • the second tumor
  • definite CML blast crisis;
  • ALL with Down's syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Xin Y Chen, Doctoral

    Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Pei J Fang, Doctoral

CONTACT

13682290830jpfang2005@163.com

Jian Wang, Master's

CONTACT

18588935208459283765@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 12, 2023

Study Start

September 27, 2022

Primary Completion (Estimated)

September 27, 2027

Study Completion (Estimated)

September 27, 2030

Last Updated

January 12, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)