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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • vincristine
  • daunorubicin
  • cyclophosphamide
  • L-Asparaginase
  • prednisone
  • mercaptopurine
  • methotrexate
  • dexamethasone
  • Tyrosine kinase inhibitor

Treatment groups

50 Participants
are divided into 1 treatment group