Acute Leukemia of Ambiguous Lineage
Conditions
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.
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
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
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). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | up to 5 years | From the date of diagnosis until the date of death from any cause, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse free survival (RFS) | up to 5 years | From the date of CR until the date of relapse or death |
| The complete remission (CR) rate | up to 2.5 years | Incidence of complete remission after induction chemotherapy |
| Mortality within 60 days | up to 60 days | Proportion of patients died within 60 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chromosomal abnormalities detected by G-banding | Baseline | — |
| Fusion genes detected by polymerase chain reaction | Baseline | — |
| Mutations detected by next-generation sequencing | Baseline | — |
| Minimal residual disease（MRD） | 1 year | The presence of small numbers of leukemic cells detected by the flow cytometry after remission |
Countries
China
Contacts
Primary ContactJianxiang Wang, Dr
Outcome results
None listed