UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044306 |
|---|---|
| Receipt number | R000050359 |
| Scientific Title | Analysis of clinical outcome in patients with therapy-related APL compared to de novo APL in the JALSG AML/MDS/CMML clinical observation study (JALSG CS-07/11-tAPL) |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/05/24 15:38:27 |
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Basic information
Public title
Analysis of clinical outcome in patients with tAPL compared to de novo APL in the JALSG AML/MDS/CMML clinical observation study (JALSG-CS-07/11) -JALSG CS-07/11-tAPL study-
Acronym
Analysis of clinical outcome in patients with tAPL in the JALSG AML/MDS/CMML clinical observation study (JALSG CS-07/11-tAPL)
Scientific Title
Analysis of clinical outcome in patients with therapy-related APL compared to de novo APL in the JALSG AML/MDS/CMML clinical observation study (JALSG CS-07/11-tAPL)
Scientific Title:Acronym
Analysis of clinical outcome in patients with tAPL in the JALSG AML/MDS/CMML clinical observation study (JALSG CS-07/11-tAPL)
Region
| Japan |
Condition
Condition
de novo and therapy-related APL (acute promyelocytic leukemia)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to determine the incidence, risk factors, response to therapy and long-term outcome in patients with therapy-related acute promyelocytic leukemia (tAPL) from the JALSG observation studies. Our aim is also to analyze the impact of additional cytogenetic abnormalities and the role of hematopoietic stem cell transplantation (HSCT) in patients with t-APL.
Basic objectives2
Others
Basic objectives -Others
Overall survival rate in patients with t-APL. Compare the survival between t-APL and de novo cases.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS) rates in patients*1 with t-APL and de novo APL, respectively.
Key secondary outcomes
1. Complete remission (CR) rates (*1)
2. Relapse free survival (*1)
3. Cumulative incidence of relapse (*1)
4. Comparison of OS, disease free survival (DFS) and event free survival (EFS)*2 between t-APL and de novo APL
*2: Event is defined as failure to achieve CR, relapse including molecular relapse, or death from any cause.
5. Age, gender, ECOG PS and additional chromosomal abnormalities of onset of APL (*1)
6. Backgrounds before the onset of t-APL: primary neoplasm, previous therapy, treatment effect, and latency period to the occurrence of t-APL
7. Comparison of clinical data and biological characteristics between therapy-related and de novo patients at the time of initial diagnosis of APL
8. Implementation status of actual administration of the chemotherapy drugs. Rates of complete remission and safety profile and grades. Incidence and outcome of hematopoietic stem cell transplantation (HSCT: allogeneic- and/or autologous-). Efficacy and safety of HSCT, such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), chronic GVHD, and so on (*3).
*3: These are the data from the Japan Society for Hematopoietic Cell Transplantation Transplant Registry Unified Management Program (TRUMP) database.
9. Association of known prognostic factors for de novo APL with prognosis in t-APL. Exploration of new prognostic factors in t-APL. Feasibility of classification according to these prognostic factors.
10. Long-term outcomes (OS, DFS, and EFS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
t-APL and de novo APL patients registered as JALSG-CS-07 or JALSG-CS-11 between 2007 and 2016.
Key exclusion criteria
For survival analysis, patients who did not receive chemotherapy-as-usual* for APL.
*: Regimens including not hypomethylating agents but all-trans retinoic acid (ATRA), arsenic trioxide (ATO), or tamibarotene (Am80).
Target sample size
670
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Maeda |
Organization
Saitama International Medical Center, Saitama Medical University
Division name
Department of Hemato-Oncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan
TEL
042-984-4111
maedat@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Maeda |
Organization
Saitama International Medical Center, Saitama Medical University
Division name
Department of Hemato-Oncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan
TEL
042-984-4111
Homepage URL
https://www.jalsg.jp/
maedat@saitama-med.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group (JALSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Adult Leukemia Study Group (JALSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan
Tel
042-984-4523
imc_irb@saitama-med.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
| 2021 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective cohort study including patients with t-APL and de novo APL, who were already enrolled in JALSG-CS-07 or CS-11 study between 2007 and 2016.
Endpoints are as follows:
1. Overall survival (OS) rates
2. Complete remission (CR) rates
3. Relapse free survival
4. Cumulative incidence of relapse
5. Comparison of OS, disease free survival (DFS) and event free survival (EFS) between t-APL and de novo APL
6. Age, gender, ECOG PS and additional chromosomal abnormalities of onset of APL.
7. Backgrounds before the onset of t-APL
8. Comparison of clinical data and biological characteristics between therapy-related and de novo patients at the time of initial diagnosis of APL.
9. Implementation status of actual administration of the chemotherapy drugs. Rates of complete remission and safety profile and grades. Incidence and outcome of hematopoietic stem cell transplantation (HSCT: allogeneic- and/or autologous-). Efficacy and safety of HSCT.
10. Association of known prognostic factors for de novo APL with prognosis in t-APL. Exploration of new prognostic factors in t-APL. Feasibility of classification according to these prognostic factors.
11. long-term outcomes (OS, DFS, and EFS)
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050359
