UMIN-CTR Clinical Trial

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
Email	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/
Email	maedat@saitama-med.ac.jp

Sponsor
Institute	Japan Adult Leukemia Study Group (JALSG)
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050359