Study of IRNEA (Irinotecan, Etoposide, Cytarabine) for Refractory or Relapsed Acute Leukemia in Children and Adolescents

Phase 1

• Conditions: Acute Leukemia
• Interventions: Drug: Irinotecan

• Registration Number: NCT01239485
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-17
• Last Update Posted: 2013-11-19
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Diagnosis of ALL or AML.

• Prior therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

  • ALL patients must have had two or more prior therapeutic attempts defined as

    • Persistent (BM blast>5%) initial disease after two induction attempts, or
    • Persistent (BM blast>5%) after re-induction attempt for first relapse or
    • Relapse after one re-induction attempt (2nd relapse)

  • AML patients must have one or more prior therapeutic attempts defined as

    • Refractory (BM blast>20%) initial disease after one induction attempts, or
    • Persistent (BM blast>5%) initial disease after two induction attempts, or
    • Relapse after one induction attempt (1st relapse)

  • Relapse after stem cell transplant: Patients are eligible 12 weeks after allogeneic stem cell transplant as long as patients are not actively being treated for GvHD and have recovered from transplant-related toxicities. Patients are eligible 8 weeks from the day of stem cell infusion for myeloablative autologous stem cell transplant, if hematological and all other eligibility criteria are met.

• Age: ≤ 21 years.

• Performance status: ECOG 0-2.

• Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

  1. Heart: a shortening fraction ≥ 28%
  2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
  3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.

• Patients must lack any active viral infections or active fungal infection.

• Patients (or one of parents if patients age < 19) should sign informed

Exclusion Criteria

1. Pregnant or nursing women.
2. Malignant (except acute leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.	28 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the incidence and severity of toxicity and treatment related mortality. 2. To evaluate the response rate. 3. To determine the pharmacokinetic profile of irinotecan in combination with etoposide, cytarabine in pediatric patients.	2 years

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of