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-

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) - Analysis of clinical outcome in patients with tAPL in the JALSG AML/MDS/CMML clinical observation study (JALSG CS-07/11-tAPL)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044306

Enrollment

670

Registered

2021-06-01

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

de novo and therapy-related APL (acute promyelocytic leukemia)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: t-APL and de novo APL patients registered as JALSG-CS-07 or JALSG-CS-11 between 2007 and 2016.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) rates in patients*1 with t-APL and de novo APL, respectively.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactTomoya Maeda

Saitama International Medical Center, Saitama Medical University Department of Hemato-Oncology

maedat@saitama-med.ac.jp042-984-4111

Outcome results