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

Sponsor
wang, jianxiang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04440267
Collaborator
(none)
50
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Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 20, 2020
Anticipated Primary Completion Date :
Jun 20, 2025
Anticipated Study Completion Date :
Dec 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: vincristine
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: daunorubicin
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: cyclophosphamide
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: L-Asparaginase
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: prednisone
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: mercaptopurine
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: methotrexate
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: dexamethasone
acute lymphoblastic leukemia (ALL) -based chemotherapy

Drug: Tyrosine kinase inhibitor
acute lymphoblastic leukemia (ALL) -based chemotherapy

Outcome Measures

Primary Outcome Measures

  1. Overall survival (OS) [up to 5 years]

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

Secondary Outcome Measures

  1. Relapse free survival (RFS) [up to 5 years]

    From the date of CR until the date of relapse or death

  2. The complete remission (CR) rate [up to 2.5 years]

    Incidence of complete remission after induction chemotherapy

  3. Mortality within 60 days [up to 60 days]

    Proportion of patients died within 60 days

Other Outcome Measures

  1. Chromosomal abnormalities detected by G-banding [Baseline]

  2. Fusion genes detected by polymerase chain reaction [Baseline]

  3. Mutations detected by next-generation sequencing [Baseline]

  4. Minimal residual disease(MRD) [1 year]

    The presence of small numbers of leukemic cells detected by the flow cytometry after remission

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

  1. 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 HBDH Tianjin Tianjin China 300020

Sponsors and Collaborators

  • wang, jianxiang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
wang, jianxiang, Director of leukemia center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT04440267
Other Study ID Numbers:
  • IHBDH-IIT2020009-EC-1
First Posted:
Jun 19, 2020
Last Update Posted:
Jun 19, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 19, 2020