NCT04440267

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Jul 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2020Dec 2027

First Submitted

Initial submission to the registry

June 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

6 years

First QC Date

June 11, 2020

Last Update Submit

August 1, 2025

Conditions

Acute Leukemia of Ambiguous Lineage

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    From the date of diagnosis until the date of death from any cause,

    up to 5 years

Secondary Outcomes (3)

  • Relapse free survival (RFS)

    up to 5 years

  • The complete remission (CR) rate

    up to 2.5 years

  • Mortality within 60 days

    up to 60 days

Other Outcomes (4)

  • Chromosomal abnormalities detected by G-banding

    Baseline

  • Fusion genes detected by polymerase chain reaction

    Baseline

  • Mutations detected by next-generation sequencing

    Baseline

  • +1 more other outcomes

Study Arms (1)

single arm

EXPERIMENTAL

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.

Drug: vincristineDrug: daunorubicinDrug: cyclophosphamideDrug: L-AsparaginaseDrug: prednisoneDrug: mercaptopurineDrug: methotrexateDrug: dexamethasoneDrug: Tyrosine kinase inhibitor

Interventions

vincristineDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
daunorubicinDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
cyclophosphamideDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
L-AsparaginaseDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
prednisoneDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
mercaptopurineDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
methotrexateDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
dexamethasoneDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm
Tyrosine kinase inhibitorDRUG

acute lymphoblastic leukemia (ALL) -based chemotherapy

single arm

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged above 14 years with acute leukemia of ambiguous lineage .
  • Eastern Cooperative Oncology Group (ECOG) Performance status 2.
  • 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).
  • 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
  • Patients should sign informed consent form.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HBDH

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Biphenotypic, Acute

Interventions

VincristineDaunorubicinCyclophosphamideAsparaginasePrednisoneMercaptopurineMethotrexateDexamethasoneTyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSulfhydryl CompoundsSulfur CompoundsPurinesAminopterinPterinsPteridinesPregnadienetriolsSteroids, FluorinatedProtein Kinase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Jianxiang Wang, Dr

CONTACT

86-22-23909120wangjx@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 19, 2020

Study Start

July 8, 2020

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

December 20, 2027

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN(1)