Clinical trial NCT03515018: Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients
Official title: Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Leukemia, Chronic Myeloid
Keywords: Leukemia, Myeloid, Chronic-Phase
hydroxyurea
Imatinib Mesylate
Pulse Therapy, Drug
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time.

PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.

Detailed description: OBJECTIVES: I. Compare the time of WBC decreased by 10%,20%,30%,50% of these patients treated with these two drugs. II. Compare the time of spleen size decreased by 10%,20%,30%,50% of chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated with hydroxyurea pulse therapy. III. Compare the time to achieve complete remission (CR) of these patients treated with these two drugs. iv. Estimate the overall survival, event-free survival, progression-free survival (OS, EFS, PFS) and major cytogenetic response of these patients treated with these two drugs.

OUTLINE: Patients are to receive one of two treatments. Arm I: Induction: Patients receive oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission. Maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 × 109 / L. Arm II: Induction: Patients receive imatinib 400mg qd until acceptable blood counts are achieved. Maintenance: Follow the recommendations of the NCCN guidelines for chronic-phase CML treatment.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 2 years.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.
2. No previous therapy with any drugs.
3. Age ≥ 16 years
4. Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
5. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.

Exclusion Criteria:

1. Patients treated with any chemotherapy drugs.
2. Patients younger than 16 years.

Primary outcomes:
measure: white blood cell count
timeFrame: 2 years
Secondary outcomes:
measure: spleen size
timeFrame: 2 years
measure: complete remission
timeFrame: 2 years
measure: long-term efficacy: OS, EFS, PFS
timeFrame: 5 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: the First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Jin Zhou, MD, PhD
role: STUDY_CHAIR
References:
citation: Valent P, Herndlhofer S, Schneeweiss M, Boidol B, Ringler A, Kubicek S, Gleixner KV, Hoermann G, Hadzijusufovic E, Mullauer L, Sperr WR, Superti-Furga G, Mannhalter C. TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML. Oncotarget. 2017 Apr 4;8(14):23061-23072. doi: 10.18632/oncotarget.15481.
citation: Huang J, Wang L, Chen L, Qun H, Yajing X, Fangping C, Xielan Z. Changing Treatment May Affect the Predictive Ability of European Treatment Outcome Study Scoring for the Prognosis of Patients with Chronic Myeloid Leukemia. Turk J Haematol. 2017 Mar 1;34(1):10-15. doi: 10.4274/tjh.2016.0156. Epub 2016 Oct 18.