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

NCT ID: NCT04440267

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2027-12-20

Brief 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.

Conditions

Acute Leukemia of Ambiguous Lineage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors.

Group Type: EXPERIMENTAL

vincristine

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

daunorubicin

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

cyclophosphamide

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

L-Asparaginase

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

prednisone

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

mercaptopurine

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

methotrexate

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

dexamethasone

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

Tyrosine kinase inhibitor

Intervention Type: DRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

Interventions

vincristine

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

daunorubicin

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

cyclophosphamide

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

L-Asparaginase

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

prednisone

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

mercaptopurine

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

methotrexate

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

dexamethasone

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

Tyrosine kinase inhibitor

acute lymphoblastic leukemia (ALL) -based chemotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged above 14 years with acute leukemia of ambiguous lineage .

2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.

3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(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 considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).

4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN

5. Patients should sign informed consent form.

Exclusion Criteria

1. Impaired cardiac function:

Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (<50 beats per minute); ejection fraction < 45 % on MUGA scan. Corrected QT (QTc) interval > 450 msec on baseline ECG (using the QTcF formula). If QTcF interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).

2. Other concurrent severe and/or uncontrolled medical conditions:

Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.

3. Patients who are: (a) pregnant and (b) breast feeding.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HBDH

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxiang Wang, Dr

Role: CONTACT

wangjx@ihcams.ac.cn

86-22-23909120

Facility Contacts

Hui Wei

Role: primary

Other Identifiers

IIT2020009

Identifier Type: -

Identifier Source: org_study_id