UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006467 |
|---|---|
| Receipt number | 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 14:59:52 |
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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
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
hgotou@kcmc.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007389
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| Registered date | File name |
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