UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II Clinical Study of Fludarabine and Etoposide in Combination with Nelarabine in Pediatric Patients with Refractory or Relapsed Acute T-lymphoblastic leukemia.
Acronym	JPLSG ALL-RT11
Scientific Title	Phase I/II Clinical Study of Fludarabine and Etoposide in Combination with Nelarabine in Pediatric Patients with Refractory or Relapsed Acute T-lymphoblastic leukemia.
Scientific Title:Acronym	JPLSG ALL-RT11
Region	Japan

Condition
Condition	Refractory or Relapsed Acute T-lymphoblastic leukemia
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of combination chemotherapy consist of nelarabine, fludarabine, and etoposide FLEND therapy) for pediatric patients with refractory or relapsed acute T-lymphoblastic leukemia (T-ALL).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	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.
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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 include 3-6 patients. Each anti-cancer drugs are administrated for 5 days. NEL: Neralabine, FLD: fludarabine, ETP: Etoposide Phase II: NEL 650mg/m2/day, FLD RP2D, ETP RP2D Phase II study includes 22-25 patients. Each anti-cancer drugs are administrated for 5 days. RP2D: Recommended phase II dose
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	20 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	31

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroaki Goto
Organization	Kanagawa Children's Medical Center
Division name	Department of Hematology and Oncology
Zip code
Address	2-138-4, Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL	+81-45-711-2351
Email	hgotou@kcmc.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroaki Goto
Organization	Kanagawa Children's Medical Center
Division name	Department of Hematology and Oncology
Zip code
Address	2-138-4, Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL	+81-45-711-2351
Homepage URL
Email	hgotou@kcmc.jp

Sponsor
Institute	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Funding Source
Organization	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	第I相試験 横浜市立大学附属病院（神奈川県）、昭和大学藤が丘病院（神奈川県）、埼玉県立小児医療センター（埼玉県）、成田赤十字病院（千葉県）、聖路加国際病院（東京都）、名古屋医療センター（愛知県）、名古屋第一赤十字病院（愛知県）、三重大学医学部附属病院（三重県）、兵庫県立こども病院（兵庫県）、鹿児島大学医学部・歯学部附属病院（鹿児島県） 第II相試験 上記施設を含む40-50施設に限定する。

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 23 Day
Date of IRB	2011 Year 07 Month 21 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 10 Month 04 Day
Last modified on	2019 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007389