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

Acute Leukemia of Ambiguous Lineage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04440267
• Other study ID #: IHBDH-IIT2020009-EC-1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 20, 2020
• Est. completion date: December 20, 2025

Study information

• Verified date: June 2020
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Jianxiang Wang, Dr
• Phone: 86-22-23909120
• Email: wangjx[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 20, 2025
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia of Ambiguous Lineage
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• vincristine
acute lymphoblastic leukemia (ALL) -based chemotherapy
• daunorubicin
acute lymphoblastic leukemia (ALL) -based chemotherapy
• cyclophosphamide
acute lymphoblastic leukemia (ALL) -based chemotherapy
• L-Asparaginase
acute lymphoblastic leukemia (ALL) -based chemotherapy
• prednisone
acute lymphoblastic leukemia (ALL) -based chemotherapy
• mercaptopurine
acute lymphoblastic leukemia (ALL) -based chemotherapy
• methotrexate
acute lymphoblastic leukemia (ALL) -based chemotherapy
• dexamethasone
acute lymphoblastic leukemia (ALL) -based chemotherapy
• Tyrosine kinase inhibitor
acute lymphoblastic leukemia (ALL) -based chemotherapy

Locations

Country	Name	City	State
China	HBDH	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
wang, jianxiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chromosomal abnormalities detected by G-banding		Baseline
Other	Fusion genes detected by polymerase chain reaction		Baseline
Other	Mutations detected by next-generation sequencing		Baseline
Other	Minimal residual disease(MRD)	The presence of small numbers of leukemic cells detected by the flow cytometry after remission	1 year
Primary	Overall survival (OS)	From the date of diagnosis until the date of death from any cause,	up to 5 years
Secondary	Relapse free survival (RFS)	From the date of CR until the date of relapse or death	up to 5 years
Secondary	The complete remission (CR) rate	Incidence of complete remission after induction chemotherapy	up to 2.5 years
Secondary	Mortality within 60 days	Proportion of patients died within 60 days	up to 60 days