UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study of clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy in adult patients with refractory or relapse acute lymphoblastic leukemia (JALSG RR-ALL214)
Acronym	JALSG RR-ALL214
Scientific Title	Phase I/II study of clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy in adult patients with refractory or relapse acute lymphoblastic leukemia (JALSG RR-ALL214)
Scientific Title:Acronym	JALSG RR-ALL214
Region	Japan

Condition
Condition	acute lymphoblastic leukemia (ALL) which is relapsed or refractory to induction therapy (including the ph chromosome positive ALL)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We decide the MTD of CLEC therapy for relapsed and refractory adult acute lymphoblastic leukemia, which uses clofarabine, etoposide and cyclophosphamide, with dose-escalation method in Phase I study. In Phase II study, we evaluate the efficacy and safety of the recommended dose which is decided in the phase I study.
Basic objectives2	Others
Basic objectives -Others	the decision of MTD and the evaluation of the efficacy and safety of the recommended doses. Investigation of safety and recommended schedule of combination chemotherapy of clofarabine, etoposide and cyclophosphamide.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I : tolerability, safety Phase II: CR (complete remission) rates, CRp rates
Key secondary outcomes	Phase I: 1) CR (complete remission) rates, CRp rate, tolerability, safety, 2) adverse event rates, 3) Overall survival, 4) reccurrence free survival time, Phase II: 1) adverse event rates, 2) Overall survival, 3) reccurrence free survival time

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	clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy
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	15 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) ALL which is relapsed or refractory to induction therapy (including the ph chromosome positive ALL). (2) Age; above 15 to younger than 60 years old. (3) PS 0-2 (ECOG) (4) Adequate hepatic, renal, pulmonary and cardiac function. SpO2 more 94%, Creatinine clearance and more 30ml/min, serum total bilirubin and less 2.0mg/dl, ECG: WNL, (5) Written informed consent.
Key exclusion criteria	1. CNS leukemia 2. Uncontrolled infection 3. Sever comorbidity (diabetes mellitus, infection or liver cirrhosis) 4. Complication of active malignant disease 5. Pregnant and/or lactating woman 6. Psychological disorder 7. Positive HBV, HIV infection 8. Judged to be inadequate
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Hatta
Organization	Sapporo Hokuyu Hospital
Division name	Department of hematology
Zip code	173-8610
Address	30-1 Okaguchi Kami-cho Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	hatta.yoshihiro@nihon-u.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Saito
Organization	The Jikei University School of Medicine
Division name	Department of Clinical oncology and hematology
Zip code	105-8471
Address	3-25-8 Nishishinbashi Minato-ku Tokyo
TEL	03-3433-1111
Homepage URL
Email	takexsaito@jikei.ac.jp

Sponsor
Institute	Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyou Jikei Medical School IRB
Address	3-25-8 Nishi-Shinbashi, Shinjyuku-ku, Tokyo
Tel	03-3433-1111
Email	takexsaito@jikei.ac.jp

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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 20 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	2014 Year 07 Month 07 Day
Date of IRB	2019 Year 01 Month 15 Day
Anticipated trial start date	2014 Year 11 Month 10 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 08 Day
Last modified on	2020 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017890