Actively Recruiting

Phase 4
Age: 1Year - 14Years
All Genders
NCT05682131

South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-01-12

210

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead Sponsor

F

First Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol

Who Can Participate

Age: 1Year - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of B or T cell type acute lymphoblastic leukemia
  • Experiencing the first recurrence of ALL
  • Classified as intermediate or high risk for ALL
Not Eligible

You will not qualify if you...

  • Diagnosis of mature B cell leukemia
  • Diagnosis of acute mixed phenotype leukemia
  • Positive for BCR/ABL fusion gene
  • Having a second tumor
  • Diagnosed with chronic myeloid leukemia blast crisis
  • ALL with Down's syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510120

Actively Recruiting

Loading map...

Research Team

P

Pei J Fang, Doctoral

CONTACT

J

Jian Wang, Master's

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here