null - FindTrial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224797

Enrollment

Registered

2019-07-23

Start date

2019-03-04

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

None listed

Interventions

Experimental:AMG 420 - Single Arm Design - Interventions:Drug: AMG 420

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1. Number of Participants With Dose-limiting Toxicities (DLTs) [Time Frame: Day 1 to Week 4] DLTs were graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with the exception of cytokine release syndrome (CRS) and tumor lysis syndrome (TLS), which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008 respectively. A participant was non-DLT evaluable if they dropped out before completion of the DLT-evaluable period for reasons other than a DLT. 2. Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) [Time Frame: Up to approximately 3 years] The severity of TEAEs were graded using the CTCAE version 5.0 with the exception of CRS and TLS, which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests were recorded as TEAEs. 3. Number of Participants Who Experienced a Treatment-related TEAE [Time Frame: Up to approximately 3 years] The severity of treatment-related TEAEs were graded using the CTCAE version 5.0 with the exception of CRS and TLS, which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008. Treatment-related TEAEs were those that were considered related to the study treatment by the investigator.	—

Measure

Time frame

1. Number of Participants With Dose-limiting Toxicities (DLTs) [Time Frame: Day 1 to Week 4] DLTs were graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with the exception of cytokine release syndrome (CRS) and tumor lysis syndrome (TLS), which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008 respectively. A participant was non-DLT evaluable if they dropped out before completion of the DLT-evaluable period for reasons other than a DLT. 2. Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) [Time Frame: Up to approximately 3 years] The severity of TEAEs were graded using the CTCAE version 5.0 with the exception of CRS and TLS, which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests were recorded as TEAEs. 3. Number of Participants Who Experienced a Treatment-related TEAE [Time Frame: Up to approximately 3 years] The severity of treatment-related TEAEs were graded using the CTCAE version 5.0 with the exception of CRS and TLS, which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008. Treatment-related TEAEs were those that were considered related to the study treatment by the investigator.

—

Secondary

Measure	Time frame
1. Overall Response Rate (ORR) [Time Frame: Up to approximately 3 years] ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (CR), CR, very good partial response (PR), or partial response as determined by the IMWG Uniform Response Criteria. The ORR along with the associated 95% exact binomial confidence interval (Clopper Pearson Method) was determined. 2. Duration of Response (DOR) [Time Frame: Up to approximately 3 years] DOR was defined as number of months between first objective response to progressive disease or death (due to any cause), whichever occurred first. Kaplan-Meier methods were used to estimate the distribution of DOR. The median and corresponding two-sided 95% confidence intervals were calculated. 3. Percentage of Participants With Minimal Residual Disease (MRD) Negativity Response at CR [Time Frame: Up to approximately 3 years] MRD negativity at CR or better assessed by using the IMWG criteria. Percentage of MRD negative responders at CR along with exact 2- sided 95% were provided by using the Clopper Pearson method. 4. Number of Participants With Minimal Residual Disease (MRD) Negativity Response at CR [Time Frame: Up to approximately 3 years] Number of participants with MRD negativity at CR or better assessed by using the IMWG criteria.	—

Measure

Time frame

1. Overall Response Rate (ORR) [Time Frame: Up to approximately 3 years] ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (CR), CR, very good partial response (PR), or partial response as determined by the IMWG Uniform Response Criteria. The ORR along with the associated 95% exact binomial confidence interval (Clopper Pearson Method) was determined. 2. Duration of Response (DOR) [Time Frame: Up to approximately 3 years] DOR was defined as number of months between first objective response to progressive disease or death (due to any cause), whichever occurred first. Kaplan-Meier methods were used to estimate the distribution of DOR. The median and corresponding two-sided 95% confidence intervals were calculated. 3. Percentage of Participants With Minimal Residual Disease (MRD) Negativity Response at CR [Time Frame: Up to approximately 3 years] MRD negativity at CR or better assessed by using the IMWG criteria. Percentage of MRD negative responders at CR along with exact 2- sided 95% were provided by using the Clopper Pearson method. 4. Number of Participants With Minimal Residual Disease (MRD) Negativity Response at CR [Time Frame: Up to approximately 3 years] Number of participants with MRD negativity at CR or better assessed by using the IMWG criteria.

—

Countries

Australia, Belgium, Switzerland, United States

Outcome results