UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015373 |
|---|---|
| Receipt number | R000017890 |
| 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) |
| Date of disclosure of the study information | 2014/10/20 |
| Last modified on | 2020/03/14 19:21:54 |
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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
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
takexsaito@jikei.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017890
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