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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006467
Receipt No. R000007389
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.
Date of disclosure of the study information 2011/10/04
Last modified on 2019/05/23

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000007389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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