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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026445
Receipt No. R000030357
Scientific Title Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)
Date of disclosure of the study information 2017/04/17
Last modified on 2018/12/21

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Basic information
Public title Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)
Acronym Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)
Scientific Title Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)
Scientific Title:Acronym Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)
Region
Japan

Condition
Condition Philadelphia chromosome-positive acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of autologous peripheral blood stem cell transplantation for patients with Philadelphia-chromosome positive acute lymphoblastic leukemia who achieved complete molecular remission within 3 chemotherapy regimens.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Day 100- mortality after transplantation
Key secondary outcomes 1) Day 100- molecular and hematological replase rate.
2) 1 year- molecular and hematological replase rate.
3) 3 year- molecular and hematological replase rate.
4) Day 100- overall survival, event-free survival, relapse rate and non-relapse mortality.
5) 1 year- overall survival, event-free survival, relapse rate and non-relapse mortality.
6) 3 year- overall survival, event-free survival, relapse rate and non-relapse mortality.
7) The proportion of therapy related mortality.
8) The proportion of adverse events in each regimen.
9) Success rate of peripheral blood stem cell harvest.
10) Detection of BCR-ABL chimeric gene in harvested peripheral blood stem cell by real-time quantitative PCR.
11) Safety of peripheral blood stem cell transplantation (the proportion of engraftment and engraftment failure).
12) Cumulative dose of dasatinib during maintenance therapy.
13) Mutation analysis of BCR-ABL chimeric gene in relapsed patients.

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 Peripheral blood stem cell harvest is performed following JALSG Ph+ALL213 C2 regimen (CPM/DNR/VCR/PSL). Peripheral blood stem cell transplantation is performed using LEED regimen (L-PAM/CPM/ETP/DEX). Between 30 and 50 days after transplantation, patients proceed to 12 courses of 4-week dasatinib-based maintenance therapy.
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
55 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Acute lymphoblastic leukemia.
2. BCR/ABL positive.
3. aged >= 55 years and <= 70 years.
4. Newly diagnosed patients.
5. Complete molecular remission was achieved within 3 chemotherapy regimens.
6. ECOG performance status of 0, 1, 2 or 3.
7. Patients must have adequate cardiac, hepatic, renal, and pulmonary functions.
8. Voluntary written consent must be given before enrollment.
Key exclusion criteria 1. Heart insufficiency.
2. Pulmonary fibrosis, interstitial pneumonitis.
3. Uncontrollable diabetes mellitus.
4. Grade 4 infection.
5. HIV antibody positive.
6. HBs antigen positive.
7. Acquired bleeding diathesis.
8. Psychiatric illness.
9. Active another malignancy.
10. Patients who, in the judgment of the investigator, would be inappropriate for entry into this study.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Nishiwaki
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya, 4668560, Japan
TEL 052(744)-2942
Email n-3104@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Nishiwaki
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya, 4668560, Japan
TEL 052(744)-2942
Homepage URL
Email n-3104@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 17 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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 07 Day
Last modified on
2018 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030357

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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