Conventional Chemotherapy in combination with or without Gemtuzumab Ozogamicin (Mylotarg) in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia (a serious malignant blood disorder which is fatal if not treated)
Phase 1
- Conditions
- Acute myeloid leukaemiaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001533-28-Outside-EU/EEA
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1070
Inclusion Criteria
Infants, Children, Adolescents, and Young Adults (<30 year old) with newly diagnosed acute myeloid leukemia (AML).
Are the trial subjects under 18? yes
Number of subjects for this age range: 1022
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Major exclusion criteria included juvenile myelomonocytic leukemia, Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome, promyelocytic leukemia (M3), secondary or treatment-related AML; prior chemotherapy, radiation therapy, or any antileukemic therapy; other prior treatment for AML.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •Event-free Survival at 3 Years <br>•Overall Survival at 3 Years <br>;Secondary Objective: •Remission Induction Rate After 2 Courses of Induction Therapy<br>•Disease-free Survival <br>•Mortality <br>•Time to Marrow Recovery <br>•Toxicities, Including Infectious Complications ;Primary end point(s): • Overall survival at 3 years, defined as time from study entry, and from<br>end of induction course 2 for patients in CR, until death.<br>• Event-free survival at 3 years defined as time from study entry until<br>death from any cause, induction failure or any relapse of any type<br>;Timepoint(s) of evaluation of this end point: Overall survival at 3 years, defined as time from study entry, and from<br>end of induction course 2 for patients in CR, until death.<br>Event-free survival at 3 years defined as time from study entry until<br>death from any cause, induction failure or any relapse of any type<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Remission rate (RR) after 2 courses of induction therapy<br>• Disease-free survival<br>• Mortality<br>• Time to marrow recovery<br>• Toxicities, including infectious complications<br>;Timepoint(s) of evaluation of this end point: Remission rate (RR) after 2 courses of induction therapy- After 2 courses of induction (I and II) therapy, assessed for up to 10 years;<br>Disease-free survival: Time from the end of course 3 (Intensification I) to death or relapse; assessed for up to 10 years; <br>Mortality: During the first three courses of therapy;<br>Time to marrow recovery: At 25 days after treatment with Induction I, Induction II, and Intensification I;<br>Toxicities, including infectious complications: From the time therapy is initiated, assessed up to 10 years