RecruitingPhase 2NCT04440267

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

A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

50 participants

Start Date

Jul 8, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether chemotherapy regimens typically used for acute lymphoblastic leukemia (ALL) can effectively treat a rare type of leukemia called acute leukemia of ambiguous lineage, which has features of both common leukemia types. **You may be eligible if...** - You are 14 years or older - You have been diagnosed with acute leukemia of ambiguous lineage - Your organ function (liver, kidneys, heart) is adequate enough to tolerate treatment - Your general health and activity level are sufficient (ECOG performance status 2 or better) **You may NOT be eligible if...** - You have a serious heart condition, including a known long QT interval on ECG - You have active uncontrolled infection - You are pregnant or breastfeeding - You have had prior treatment for this leukemia (except emergency stabilizing treatment) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGvincristine

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGdaunorubicin

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGcyclophosphamide

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGL-Asparaginase

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGprednisone

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGmercaptopurine

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGmethotrexate

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGdexamethasone

acute lymphoblastic leukemia (ALL) -based chemotherapy

DRUGTyrosine kinase inhibitor

acute lymphoblastic leukemia (ALL) -based chemotherapy


Locations(1)

HBDH

Tianjin, Tianjin Municipality, China

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NCT04440267


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