ReCALL: Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals)
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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)
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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]
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Bone marrow aspiration
Study Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Safety/Efficacy [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.
Secondary Outcome Measures
- Disease-free survival rate (Blinatumomab) [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
- Disease-free survival rate (standard risk) [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
- Disease-free survival rate (Comparing minimal residual disease) [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
- Death rate related to treatment [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
- Death rate related to toxicity [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
- Toxicity rate during consolidation therapy [through study completion, an average of 9 year]
Checking occurence rate of toxicity related to treatment during consolidation for patients in low-risk group
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who are confirmed as relapse, aged above a year (12 months), below 22
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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)
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Patients who have never received allogeneic stem cell transplant
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Patients who have never received blinatumomab before
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Patients who relapsed within a month after completing 4 therapies
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Adequate Renal Function Creatinine clearance or radioisotope Glomerular filtration rate≥ 70 mL/min/1.73 m2, or
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
Exclusion Criteria:
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Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
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Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome
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Patients with HIV
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Severance Hospital | Seoul | Gangnam-gu | Korea, Republic of | 03722 |
| 2 | Samsung Medical Center | Seoul | Gangnam-gu | Korea, Republic of | 06351 |
| 3 | The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | Gangnam-gu | Korea, Republic of | 06591 |
| 4 | Seoul National University Hospital | Seoul | Jongro-gu | Korea, Republic of | 03080 |
| 5 | Asan Medical Center | Seoul | Korea, Republic of | 05505 |
Sponsors and Collaborators
- Ho Joon Im
Investigators
- Study Chair: Ho Joon Im, Professor, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KPHOG_T1RALL2201