ALL-style chemotherapy for people with acute leukemia of ambiguous lineage.

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

This trial will try ALL-style chemotherapy (including vincristine, daunorubicin, cyclophosphamide, L-asparaginase, and prednisone) in people aged 14 and older with acute leukemia of ambiguous lineage and may offer stem-cell transplant after remission.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT04440267 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label Phase 2 trial enrolling 50 patients with acute leukemia of ambiguous lineage to receive an ALL-based chemotherapy regimen. Patients with the t(9;22) abnormality will receive tyrosine kinase inhibitors in addition to chemotherapy, and those who achieve complete remission may proceed to allogeneic hematopoietic stem cell transplant; others will continue consolidation chemotherapy. The study will measure clinical responses, track minimal residual disease (MRD), and relate genetic abnormalities to outcomes. Data will be used to estimate remission rates and inform prognosis for this uncommon leukemia subtype.

Who should consider this trial

Good fit: People aged 14 years or older with a diagnosis of acute leukemia of ambiguous lineage who meet the trial's performance-status and organ-function requirements and can give informed consent.

Not a fit: Patients with significant cardiac impairment, uncontrolled organ dysfunction, long QT syndrome, or who cannot tolerate intensive chemotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the regimen could raise remission rates and help tailor further therapy based on genetic findings and MRD status for patients with ambiguous-lineage acute leukemia.

How similar studies have performed: Some retrospective series and small prospective reports suggest ALL-based regimens can produce remissions in mixed-phenotype or ambiguous-lineage leukemias, but high-quality randomized evidence is limited.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Hbdh — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jianxiang Wang, Dr

Conditions Acute Leukemia of Ambiguous Lineage