Phase I/II Clinical Study of Fludarabine and Etoposide in Combination with Nelarabine in Pediatric Patients with Refractory or Relapsed Acute T-lymphoblastic leukemia.

Phase I/II Clinical Study of Fludarabine and Etoposide in Combination with Nelarabine in Pediatric Patients with Refractory or Relapsed Acute T-lymphoblastic leukemia. - JPLSG ALL-RT11

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006467

Enrollment

Registered

2011-10-04

Start date

2011-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory or Relapsed Acute T-lymphoblastic leukemia

Interventions

Phase I: level-2 NEL 650, FLD 20, ETP 50 mg/m2/day level-1 NEL 650, FLD 20, ETP 75 mg/m2/day level 1 NEL 650, FLD 30, ETP 75 mg/m2/day level 2 NEL 650, FLD 30, ETP 100 mg/m2/day Each levels inclu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provide signed, written informed consent. 2. T-ALL patients with induction failure or > or = 1st relapse. 3. T-ALL patients should have >25% blasts present in the bone marrow. 4. Be > or = 1 year old, and be <18 years old at time of disease onset 5. Have a Eastern Cooperative Oncology Group Performance Status (PS) of 0-2. 6. Have adequate liver, renal, and cardiac function.

Exclusion criteria

Exclusion criteria: 1. Have central nervous system involvement. 2. Have history of receiving hematopoietic cell transplantation 3. Secondary T-ALL 4. Have other malignancy 5. Are pregnant or lactating. 6. Have psychiatric disorders that would interfere with consent, study participation, or follow-up. 7. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or pancreas.

Design outcomes

Primary

Measure	Time frame
Phase I: To determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and the recommended Phase 2 dose (RP2D) of FLEND therapy in pediatric patients with relapsed or refractory T-ALL. Phase II: To estimate the overall response (OR) rate of FLEND therapy in pediatric patients with refractory or relapsed T-ALL.	—

Secondary

Measure	Time frame
1. Incidence rate of adverse event 2. Overall response rate 3. Complete response rate 4. Event-free survival (4-month and 1-year) 5. Overall survival (4-month and 1-year) 6. Pharmacokinetic (PK) study 7. Minimal residual disease (MRD) 8. Drug-resistant genes	—

Countries

Japan

Contacts

Public ContactHiroaki Goto

Kanagawa Children's Medical Center Department of Hematology and Oncology

hgotou@kcmc.jp+81-45-711-2351

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026