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

March 18, 2024 updated by: Ho Joon Im

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center
        • Contact:
          • Hee Young Ju, Professor
      • Seoul, Gangnam-gu, Korea, Republic of, 03722
        • Severance Hospital
        • Contact:
          • Seung Min Hahn, Professor
      • Seoul, Gangnam-gu, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St.Mary's Hospital
        • Contact:
          • Jae Wook Lee, Professor
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
        • Contact:
          • Hee Jo Baek, Ph.D
    • Jongro-gu
      • Seoul, Jongro-gu, Korea, Republic of, 03080
        • Seoul National University Hospital
        • Contact:
          • Hyoung Jin Kang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single group study
Apply Blinatumomab Cycle 1,2, S cycle 1, 2 (High Risk Group)- 4 weeks to patients before transplantation
Drug: Blincyto
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.
Other Names:
  • Blinatumomab (Amgen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/Efficacy
Time Frame: through study completion, an average of 9 year
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.
through study completion, an average of 9 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival rate (Blinatumomab)
Time Frame: through study completion, an average of 9 year
Blinatumomab is used before transplantation to patients with high-risk group, and then disease-free survival rate will be compared before and after
through study completion, an average of 9 year
Disease-free survival rate (standard risk)
Time Frame: through study completion, an average of 9 year
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
through study completion, an average of 9 year
Disease-free survival rate (Comparing minimal residual disease)
Time Frame: through study completion, an average of 9 year
Comparing minimal residual disease negative rate with the study before by adding blinatumomab to patients in high risk group
through study completion, an average of 9 year
Death rate related to treatment
Time Frame: through study completion, an average of 9 year
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
through study completion, an average of 9 year
Death rate related to toxicity
Time Frame: through study completion, an average of 9 year
Comparing remission rate and occurrence rate of toxicity during re-intervention therapy after changed schedules of idarubicin
through study completion, an average of 9 year
Toxicity rate during consolidation therapy
Time Frame: through study completion, an average of 9 year
Checking occurence rate of toxicity related to treatment during consolidation for patients in low-risk group
through study completion, an average of 9 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ho Joon Im

Investigators

  • Study Chair: Ho Joon Im, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KPHOG_T1RALL2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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