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Acute Lymphoid LeukemiaPhase 2ReCALLNCT05827549

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

A Phase 2 study testing Reinduction(4weeks), Cosolodation 1st(3weeks) and Consolidation 2nd(3weeks) in people with Acute Lymphoid Leukemia, run by Ho Joon Im at 10 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and… Read more about this study

Who is it for?
Ages 1 year to 22 years
Conditions the study is for
Acute Lymphoid Leukemia
What is being tested?
Reinduction(4weeks), Cosolodation 1st(3weeks) and Consolidation 2nd(3weeks)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
10 sitesSouth Korea
Study dates
4 Apr 2024to 31 Dec 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 17Show fewer
  • Patients who have never received blinatumomab before
  • Adequate Renal Function
  • -A serum creatinine based on age/gender as follows:
  • 1 to \&lt; 2 years - Male (0.6) Female (0.6) 2 to \&lt; 6 years - Male (0.8) Female (0.8) 6 to \&lt; 10 years - Male (1) Female (1) 10 to \&lt; 13 years - Male (1.2) Female (1.2) 13 to \&lt; 16 years - Male (1.5) Female (1.4)
  • ≥ 16 years - Male (1.7) Female (1.4)
  • Adequate Liver Function defined as a direct bilirubin \&lt;3.0 mg/dL
  • Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram
  • Lansky (age \&lt; 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

Who cannot join

  • 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.
Show all 13Show fewer
  • Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome
  • Patients with known 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\&#39; 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ho Joon Im contact

+82-10-6231-1573

hojim@amc.seoul.kr

10 sites in 1 country

South Korea10 sites, 10 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Ji Yoon Kim, Professor, +82-53-200-5704, phojyk@knu.ac.kr

    Not yet recruiting

  • Chungnam National University Hospital

    Daejeon, 35015

    Yeon Jung Lim, Professor, +82-10-2705-1743, heagori@daum.net

    Not yet recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

    Hee Jo Baek, Ph.D, +82-10-4607-1784, swan93@naver.com

    Recruiting

  • Jeju National University Hospital

    Jeju City, 63241

    Hyun Sik Kang, Professor, +82-64-717-1528, medyapsb@naver.com

    Not yet recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Hyoung Jin Kang, Professor

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Seung Min Hahn, Professor, +82-10-8821-5201, bluenile88@yuhs.ac

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Ho Joon Im, Professor, 8201062311573, hojim@amc.seoul.kr

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Hee Young Ju, Professor

    Recruiting

  • Seoul saint Mary's Hospital

    Seoul, 06591

    Jae Wook Lee, Professor, +821026460668, dashwood@catholic.ac.kr

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

    Eu Jeen Yang, Professor, +82-10-6478-8489, 41sirius@hanmail.net

    Recruiting

Other trials in South Korea

About this study

This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.

Read the detailed description

The Risk Assessment is classified as follows based on the NGS-MRD results evaluated after EOI(End of Induction).

<Standard Risk>

  • Late (Relapse ≥ 1 year after off treatment) B-ALL marrow or Combined relapse AND
  • End of induction MRD < 0.01%

<High Risk>

  • T-ALL marrow or combined relapse (any timing)
  • All other B-ALL marrow or combined relapse cases

<Very High Risk>

  • End of Induction BM ≥ M2 AND B -ALL marrow or combined relapse
Being tested
Reinduction(4weeks), Cosolodation 1st(3weeks), Consolidation 2nd(3weeks), Blinatumomab 1st(High Risk Group)_4 Weeks, Blinatumomab 2nd (High Risk Group)_4 Weeks
Keywords
combination chemotherapy
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reinduction(4weeks)Drug

    Prednisolone 60 mg/m2/day tid days 1-28, Vincristine 1.5 mg/m2 on days 1, 8, 15, 22, L-asparaginase 6,000 IU/m2(days 2-4 start, total 9 doses for 3 weeks), Idarubicin 10 mg/m2 on days 1, 8, (15~17), IT Ara-C on days 1, IT MTX on days 8, 29

  • Cosolodation 1st(3weeks)Drug

    Ifosfamide: 1.8 g/m2 (days 1, 2, 3, 4, 5), Etoposide: 100 mg/m2 (days 1, 2, 3, 4, 5), IT MTX on day 1

  • Consolidation 2nd(3weeks)Drug

    MTX: 500 mg/m2 over 30 min followed by 1,000 mg/m2 over 23.5 hr (day 1), Ara-C: 3,000 mg/m2/dose (day 2, 3), IT MTX on day 1

  • Blinatumomab 1st(High Risk Group)_4 WeeksDrug

    Blinatumomab 15 mcg/m²/day(Days: 1-28), Dexamethasone 5 mg/m2/dose on Day 1, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

  • Blinatumomab 2nd (High Risk Group)_4 WeeksDrug

    Blinatumomab 15 mcg/m²/day(Days: 1-28), IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

  • Blinatumomab-Salvage 1st (Very High Risk Group)_4 WeeksDrug

    Blinatumomab 9 mcg/day(Weight ≥ 45kg) or 5 mcg/m²/day(Weight < 45kg) on 1-7 days, 28 mcg/day(Weight ≥ 45kg) or 15 mcg/m²/day(Weight < 45kg) on 8-28 days, Dexamethasone 5 mg/m2/dose on day 1 and day 8, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

  • Blinatumomab-Salvage 2nd (Very High Risk Group)_4 WeeksDrug

    Blinatumomab 28 mcg/day(Weight ≥ 45kg) or 15 mcg/m²/day(Weight < 45kg) on 1-28 days, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

  • Intensification courseDrug

    <Intensification 1st(3 Weeks)> Etoposide: 100 mg/m2 on day 1, 2, 3, Ifosfamide 3.4 g/m2 on day 1, 2, 3

    <Intensification 2nd(2 Weeks)> Oral 6-mercaptopurine 50 mg/m2/day PO (days 1-14), Methotrexate: 25 mg/m2 on day 1, 8, TIT on day 1

    <Intensification 3rd(3 Weeks)> Ara-C 1.0 g/m2 (days 1-3), Idarubicin: 5mg/m2 (days 1- 3)

    <Intensification 4th(2 Weeks)> Dexamethasone 8 mg/m2/day on days 1-14, Vincristine 2 mg/m2 on days 1 and 8, L-asparaginase 10,000 IU/m2 on days 1 and 8

  • Maintenance(12 Weeks/Cycle)Drug

    Prednisolone: 15 mg/m²/dose(Days 1-5, 29-33, 57-61), Vincristine: 1.5 mg/m²/dose(Day 1, 29, 57), Oral 6-mercaptopurine: 50 mg/m²/dose (Days 1-84), Methotrexate: 20 mg/m²/dose (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78), Intrathecal methotrexate (Day 1)

  • Stem Cell TransplantationProcedure or surgery

    All matters related to hematopoietic stem cell transplantation are subject to each institution's practice.

Study groups in NCT05827549
Study groupRoleWhat they receive
Standard Risk group with B-ALLExperimentalReinduction -> Consolidation 1st -> Consolidation 2nd -> Repeat the Intensification course in parentheses 3 times(Intensification 1st -> Intensification 2nd -> Intensification 3rd -> Intensification 4th) -> Maintenance
Receives: Drug: Reinduction(4weeks); Drug: Cosolodation 1st(3weeks); Drug: Consolidation 2nd(3weeks); Drug: Intensification course; Drug: Maintenance(12 Weeks/Cycle)
High Risk group with B-ALLExperimentalReinduction -> Consolidation 1st -> Consolidation 2nd -> Blinatumomab 1st -> Blinatumomab 2nd -> HSCT
Receives: Drug: Reinduction(4weeks); Drug: Cosolodation 1st(3weeks); Drug: Consolidation 2nd(3weeks); Drug: Blinatumomab 1st(High Risk Group)_4 Weeks; Drug: Blinatumomab 2nd (High Risk Group)_4 Weeks; Procedure: Stem Cell Transplantation
Very high Risk with B-ALLExperimentalReinduction -> Blinatumomab-Salvage 1st -> Blinatumomab-Salvage 2nd -> HSCT
Receives: Drug: Reinduction(4weeks); Drug: Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks; Drug: Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks; Drug: Intensification course
T-ALLExperimentalReinduction -> Consolidation 1st -> Consolidation 2nd -> HSCT
Receives: Drug: Reinduction(4weeks); Drug: Cosolodation 1st(3weeks); Drug: Consolidation 2nd(3weeks); Procedure: Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 9 year

Secondary outcomes (6)

  1. 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

    Measured: through study completion, an average of 9 year

  2. 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

    Measured: through study completion, an average of 9 year

  3. 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

    Measured: through study completion, an average of 9 year

  4. 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

    Measured: through study completion, an average of 9 year

  5. Death rate related to toxicity

    Comparing remission rate and occurrence rate of toxicity during re-intervention therapy after changed schedules of idarubicin

    Measured: through study completion, an average of 9 year

  6. Toxicity rate during consolidation therapy

    Checking occurence rate of toxicity related to treatment during consolidation for patients in low-risk group

    Measured: through study completion, an average of 9 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start4 Apr 2024
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827549
Sponsor's protocol ID
KPHOG_T1RALL2201
Acronym
ReCALL
Status last verified
Jul 2026
First submitted
16 Mar 2023
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Reinduction(4weeks), Cosolodation 1st(3weeks) and Consolidation 2nd(3weeks) in people with Acute Lymphoid Leukemia, run by Ho Joon Im at 10 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ho Joon Im (+82-10-6231-1573, hojim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety/Efficacy (time frame: through study completion, an average of 9 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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