search
Back to results

Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia (ReCALL)

Primary Purpose

Acute Lymphoid Leukemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Blincyto
Sponsored by
Ho Joon Im
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Lymphoid Leukemia focused on measuring combination chemotherapy

Eligibility Criteria

1 Year - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 Patients who relapsed within a month after completing 4 therapies 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 Patients with mixed phenotype leukemia 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

Sites / Locations

  • Severance Hospital
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St.Mary's Hospital
  • Seoul National University Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group study

Arm Description

Apply Blinatumomab Cycle 1,2, S cycle 1, 2 (High Risk Group)- 4 weeks to patients before transplantation

Outcomes

Primary Outcome Measures

Safety/Efficacy
Patients with relapsed acute lymphoblastic leukemia are being treated after sorted into groups with their potential risk, and disease-free survival rate will be checked.

Secondary Outcome Measures

Disease-free survival rate (Blinatumomab)
Blinatumomab is used before transplantation to patients with high-risk group, and then disease-free survival rate will be compared before and after
Disease-free survival rate (standard risk)
Patients with standard risk who are not eligible for allogenic stem cell transplantation are given consolidation and maintenance therapies, and disease-free survival rate will compared before and after
Disease-free survival rate (Comparing minimal residual disease)
Comparing minimal residual disease negative rate with the study before by adding blinatumomab to patients in high risk group
Death rate related to treatment
Children and adolescents who have relapsed acute lymphoblastic leukemia re administered different treatments depending on their assigned groups, and disease-free survival rate will be compared before and after
Death rate related to toxicity
Comparing remission rate and occurrence rate of toxicity during re-intervention therapy after changed schedules of idarubicin
Toxicity rate during consolidation therapy
Checking occurence rate of toxicity related to treatment during consolidation for patients in low-risk group

Full Information

First Posted
March 16, 2023
Last Updated
June 29, 2023
Sponsor
Ho Joon Im
search

1. Study Identification

Unique Protocol Identification Number
NCT05827549
Brief Title
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Acronym
ReCALL
Official Title
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 14, 2023 (Anticipated)
Primary Completion Date
December 31, 2032 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ho Joon Im

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals) 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) 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] Bone marrow aspiration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoid Leukemia
Keywords
combination chemotherapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Blinatumomab Cycle 1,2 S cycle 1,2 (High risk group) is going to be given for 4 weeks before transplantation
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single group study
Arm Type
Experimental
Arm Description
Apply Blinatumomab Cycle 1,2, S cycle 1, 2 (High Risk Group)- 4 weeks to patients before transplantation
Intervention Type
Drug
Intervention Name(s)
Blincyto
Other Intervention Name(s)
Blinatumomab (Amgen)
Intervention 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.
Primary Outcome Measure Information:
Title
Safety/Efficacy
Description
Patients with relapsed acute lymphoblastic leukemia are being treated after sorted into groups with their potential risk, and disease-free survival rate will be checked.
Time Frame
through study completion, an average of 9 year
Secondary Outcome Measure Information:
Title
Disease-free survival rate (Blinatumomab)
Description
Blinatumomab is used before transplantation to patients with high-risk group, and then disease-free survival rate will be compared before and after
Time Frame
through study completion, an average of 9 year
Title
Disease-free survival rate (standard risk)
Description
Patients with standard risk who are not eligible for allogenic stem cell transplantation are given consolidation and maintenance therapies, and disease-free survival rate will compared before and after
Time Frame
through study completion, an average of 9 year
Title
Disease-free survival rate (Comparing minimal residual disease)
Description
Comparing minimal residual disease negative rate with the study before by adding blinatumomab to patients in high risk group
Time Frame
through study completion, an average of 9 year
Title
Death rate related to treatment
Description
Children and adolescents who have relapsed acute lymphoblastic leukemia re administered different treatments depending on their assigned groups, and disease-free survival rate will be compared before and after
Time Frame
through study completion, an average of 9 year
Title
Death rate related to toxicity
Description
Comparing remission rate and occurrence rate of toxicity during re-intervention therapy after changed schedules of idarubicin
Time Frame
through study completion, an average of 9 year
Title
Toxicity rate during consolidation therapy
Description
Checking occurence rate of toxicity related to treatment during consolidation for patients in low-risk group
Time Frame
through study completion, an average of 9 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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 Patients who relapsed within a month after completing 4 therapies 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 Patients with mixed phenotype leukemia 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Joon Im, Professor
Phone
+82-2-3010-3371
Email
hojim@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Joon Im, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Min Hahn, Professor
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Young Ju, Professor
Facility Name
The Catholic University of Korea Seoul St.Mary's Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Wook Lee, Professor
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongro-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, Professor
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Joon Im, Professor
Email
hojim@amc.seoul.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia

We'll reach out to this number within 24 hrs