Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05832320

Optimum Induction Therapy of Low-risk APL

Led by Peking University People's Hospital · Updated on 2024-05-10

74

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Despite the high cure probability for acute promyelocytic leukemia (APL), a minority of patients will relapse and the risk factors for relapse are unclear. The goal of this clinical trial is to compare the effectiveness and safety of induction of oral all-trans retinoic acid (ATRA) and realgar-indigo naturalis formula (RIF) combined with oral etoposide or daunorubicin as cytoreductive therapies in low-risk APL. The present study was to explored a cytoreduction of an oral etoposide for low-risk APL with dual induction of ATRA and RIF as a high efficacy, low recurrence, and more convenient all-oral regimen.

CONDITIONS

Official Title

Optimum Induction Therapy of Low-risk APL

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed APL patients according to WHO 2008 diagnostic classification
  • Aged between 18 and 75 years
  • Liver function tests: ALT and AST no more than 2.5 times upper limit of normal, bilirubin no more than 2 times upper limit of normal
  • Renal function: muscle salt (creatinine) no more than 3 times upper limit of normal
  • Physical strength score (ECOG) between 0 and 2
  • White blood cell count no greater than 10 x 10^9/L
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Participation in other clinical trials within the past 30 days
  • Pregnant or breastfeeding
  • Positive HIV serological test
  • Positive viral hepatitis serological test
  • Severe arrhythmia or abnormal electrocardiogram (QT interval greater than 500 ms)
  • Mental illness or inability to cooperate with treatment and monitoring
  • Participation in other clinical research simultaneously
  • Failure to sign informed consent form
  • Other conditions deemed unsuitable by the researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Institute of Hematology

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

X

Xiaolu Zhu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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