Actively Recruiting

Phase 2
Age: 14Years +
All Genders
NCT04440267

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06

50

Participants Needed

1

Research Sites

388 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy,effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.

CONDITIONS

Official Title

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged above 14 years with acute leukemia of ambiguous lineage
  • Eastern Cooperative Oncology Group (ECOG) Performance status 2
  • Adequate organ function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); SGOT and SGPT ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless tumor related
  • Adequate cardiac function with ejection fraction ≥ 45% on MUGA scan
  • Laboratory values at or above lower limit of normal (LLN) for potassium, magnesium, and phosphorus, or corrected to normal before first dose
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Impaired cardiac function: long QT syndrome or family history; resting bradycardia (<50 bpm); ejection fraction < 45% on MUGA; QTc interval > 450 msec on ECG after electrolyte correction
  • Myocardial infarction within 12 months before study start
  • Other significant heart diseases such as unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmias
  • Other severe or uncontrolled medical conditions including another primary malignant disease requiring treatment, acute or chronic liver, pancreatic or severe renal disease
  • Pregnant or breastfeeding women

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

HBDH

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

J

Jianxiang Wang, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage | DecenTrialz