Trial Title:
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
NCT ID:
NCT05827549
Condition:
Acute Lymphoid Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Blinatumomab
Conditions: Keywords:
combination chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Blinatumomab Cycle 1,2 S cycle 1,2 (High risk group) is going to be given for 4 weeks
before transplantation
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Blincyto
Description:
Vincristine 1.5mg/m2, L-asparaginase 6,000 IU/m2 Idarubicin 10mg/m2 will be administered
for induction therapy. Ifosfamide 1.8g/m2 Etoposide 100mg/m2 will be administered for
consolidation therapy, then patients will be sorted into groups depend on their potential
risk and Blinatumomab IV will be administered over 28 days. Intensification course will
be administered 4 times repeated. 1. etoposide 100mg/m2 Ifosfamide 3.4g/m2 with MESNA /
2.oral 6-mercaptopurine 50mg/m2, methotrexate 25mg/m2 / 3.Ara-C 1.0g/m2, Idarubicin
5mg/m2 / 4.vincristine 2mg/m2 are the courses for repetition.
Arm group label:
Single group study
Other name:
Blinatumomab (Amgen)
Summary:
This study is open-label, multi-center, prospective study, which targets childhood
patients with recurred acute lymphostatic leukemia including recurrence around marrow.
This study is designed to administer Idarubicin for Reinduction stage. Patients with
recurrence are sorted into groups with their potential risk, and depending on their
recurrence point, time, reaction to treatment etc, they are sorted into low-risk group,
high-risk group, and highest-risk group.
Patients with high-risk group are going to be given blinatumomab at consolidation stage
before hematopoietic stem cell transplantation.
Patients with low-risk group who are not suitable for hematopoietic stem cell
transplantation are going to be maintaining maintenance therapy for 2 years for
chemotherapy.
Detailed description:
1. Baseline demographics: Sex, Birth date, expire date (last follow-up date for the
survivals)
2. Diagnosis of Acute lymphoblastic leukemia and treatment history: Diagnosed date,
treatment history (Stem cell transplantation history, Administration of Blinatumomab
history, recurrence date to check whether recurred within a month after received 4
therapies of induction)
3. Tests before actual administration: EKG and or Echo, Blood sample: Complete Blood
Count/Diff/Platelets, Chemistry, Urinalysis, HIV, human chorionic gonadotrophin
[female], Minimal Residual Disease[Next-generation sequencing, after induction /
could be done after 1st, 2nd consolidation therapy]
4. Bone marrow aspiration
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients >= 1 year and < 22 years of age at the time of relapse will be
eligible
- Participants must have a histologic diagnosis of acute lymphoblastic leukemia:
- B-ALL: Precursor B-cell acute lymphoblastic leukemia
- T-ALL: Precursor T-cell acute lymphoblastic leukemia
- 1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow.
Enrolling patients with combined extra medullary relapse including bone marrow is
acceptable. (No limits for extra medullary site) Additionally, subjects whose blast
cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite)
- Patients who have never received allogeneic stem cell transplant
- Patients who have never received blinatumomab before
- Adequate Renal Function
-A serum creatinine based on age/gender as follows:
1 to < 2 years - Male (0.6) Female (0.6) 2 to < 6 years - Male (0.8) Female
(0.8) 6 to < 10 years - Male (1) Female (1) 10 to < 13 years - Male (1.2)
Female (1.2) 13 to < 16 years - Male (1.5) Female (1.4)
≥ 16 years - Male (1.7) Female (1.4)
- Adequate Liver Function defined as a direct bilirubin <3.0 mg/dL
- Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by
echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram
- Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% at
screening
- Patients with a life expectancy of 1 or more year
- Patients who are expected to comply with all required study procedures and follow
the study protocol in the opinion of the investigator
- Signed written informed consent and assent forms must be obtained prior to any study
procedures
Exclusion Criteria:
- Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
- Patients with Philadelphia chromosome positive (Ph+) ALL
- Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia
(non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are
not eligible for administration of Blinatumomab
- In case of relapsed within 1 month after the end of induction with the same 4-drug
therapy used in this study
- Patients with mixed phenotype leukemia
- patient who was relapsed within 1 month after the end of induction therapy with the
same 4-drug regimen to be used in this study.
- Patients with genetic syndrome: Down syndrome, Bloom syndrome,
ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone
marrow failure syndrome
- Patients with HIV
- Female patients who are not proved as infertile or pregnant (Evidence of
infertility: History taking of possibilities of pregnancy or urine human chorionic
gonadotrophin test negative, amenorrhea more than a year, Natural or artificial
(Ex.hormone therapy) menopause status more than a year, surgical
sterilization(Ex.Hysterectomy or ovariotomy etc)
- Currently receiving treatment in another investigational drug study or clinical
trial
- Evidence of unstable conditions that would pose a risk to subject safety or
interfere with the patients' compliance
- Patients with clinically relevant central nervous system (CNS) pathology or active
CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis,
aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome,
psychosis, coordination/movement disorder
- Known hypersensitivity to drugs or components to be administered: Idarubicin,
Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab
Gender:
All
Minimum age:
1 Year
Maximum age:
22 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seung Min Hahn, Professor
Phone:
+82-10-8821-5201
Email:
bluenile88@yuhs.ac
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hee Young Ju, Professor
Facility:
Name:
The Catholic University of Korea Seoul St.Mary's Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jae Wook Lee, Professor
Phone:
+821026460668
Email:
dashwood@catholic.ac.kr
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Hee Jo Baek, Ph.D
Phone:
+82-10-4607-1784
Email:
swan93@naver.com
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyoung Jin Kang, Professor
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ho Joon Im, Professor
Phone:
8201062311573
Email:
hojim@amc.seoul.kr
Start date:
April 4, 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Ho Joon Im
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05827549
