By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study.  For more information, including how to unsubscribe at any time, see our

A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

ABOUT CLINICAL TRIALS

FAQS

Have questions about or want more information about A Study of LY3471851 in Participants With Gastric Cancer? Contact us by filling out your information below and we’ll respond to you.

Purpose [I would like…]

Requestor Information [I am…]

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under “Sponsor Specific Details for Astellas.”

Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) and R/R higher risk Myelodysplastic Syndrome (MDS) received intravenous (IV) infusion of ASP7517 (human embryonic kidney cell [HEK293] transfected with encoding target WT-1) at a dose of 1x10^6 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).

Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).

Participants with R/R AML and R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 2 doses (1 cycle= 28 days).

Participants with R/R AML received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).

Participants with R/R higher risk MDS received IV infusion of ASP7517 (HEK293 transfected with encoding target WT-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for 6 doses (1 cycle= 28 days).

Redacted CSR Synopsis

PLS_English-7517-CL-0101.docx

Redacted Protocol English

Redacted SAP English

The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517. 

This study also evaluated the clinical response of ASP7517 as well as other measures of anticancer activity of ASP7517.

This study consisted of 2 parts: phase 1 dose escalation and phase 2 dose expansion.

Phase 1 Dose Escalation:

Approximately 18 subjects with either relapsed/refractory (R/R) AML or R/R higher risk MDS were enrolled. Participants received 2 single doses of ASP7517 via intravenous infusion. Dosing occured on day 1 of each cycle. Each cycle was defined as 28 days with a total of 2 treatment cycles.

Participants were managed under hospitalization for at least 7 days during the first cycle of the dose escalation phase. In addition, prior to hospital discharge, participant safety was ensured by performing medical tests and procedures listed on day 7 of cycle 1 and tests considered clinically necessary to evaluate the participant's general condition and adverse event (AE) resolution. The participant was also followed on an outpatient basis on planned visits during cycles 1 and 2 after hospital discharge during the dose limiting toxicity (DLT) assessment period to closely monitor any AEs. Participants were hospitalized days 1 to 7 during cycle 2.

Phase 2 Dose Expansion:

Approximately 104 participants per dose level were enrolled. Each dose level enrolled up to 52 R/R AML participants and up to 52 R/R higher risk MDS participants. Both groups of participants were enrolled in parallel and independently. The number of dose levels investigated during phase 2 were based upon the data from phase 1. When escalation and expansion cohorts were both open for enrollment, enrollment into escalation cohorts took priority such that participants who were eligible for both were preferentially enrolled in the escalation cohorts.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to plain language summary of the study on the Trial Results Summaries website.

Link to results and other applicable study documents on the Astellas Clinical Trials website.

Site JP81004

Site JP81007

Site JP81008

Site JP81005

Site JP81001

Site JP81002

Site JP81009

Site JP81010

Site JP81011

Site JP81013

Site JP81012

Site JP81016

Site JP81014

Gabrail Cancer Center

Memorial Healthcare System-West

City of Hope

Site JP81017

Site JP81015

University of Chicago Comprehensive Cancer Center

NYU Langone Health

Northside Hospital Cancer Institute

MD Anderson Cancer Center

UAB O’Neal Comprehensive Cancer Center

A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

A DLT is defined as any of the following events that occur within 28 days starting with the first dose on cycle 1 day 1 (C1D1) and that is considered to be related to investigation product (IP). The severity of AEs will be assessed according to National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. DLT is defined as follows: non-hematologic AEs that are ≥ grade 3; confirmed Hy’s law case; new onset of grade 4 thrombocytopenia (with minimum of 2 grade worsening from baseline) within 24 hours of dosing; prolonged myelosuppression, defined as absolute neutrophil count (ANC) < 500/μL for more than 28 days off therapy and in the absence of evidence of active leukemia or MDS in the marrow or blood, will be considered as a DLT.

An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be graded using NCI-CTCAE guidelines, version 5.0.

An AE is considered “serious” if the event: results in death; is life-threatening (An AE is considered “life-threatening” if its occurrence places the subject at immediate risk of death; it does not include an AE that, had it occurred in a more severe form, might have caused death.); results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect;  requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); other medically important events.

Number of participants with potentially clinically significant laboratory values.

Routine 12-lead ECGs will be taken after the subject has been resting in the supine position for at least 5 minutes. Routine 12-lead ECGs will be taken in triplicate during the Screening and Treatment Periods, and as a single assessment (in triplicate, if deemed necessary) during the Observation Periods 1 and 2.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant physical exam values.

The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

CRc rate is defined for AML subjects as the number of participants who achieve the best response of CRc (complete remission [CR], complete remission with incomplete platelet recovery [CRp] or complete remission with incomplete hematological recovery [CRi]) divided by the number of participants in the analysis population.

CR + BM CR + PR rate is defined for MDS participants as the number of participants who achieve the best response of CR + BM CR + PR divided by the number of subjects in the analysis population.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Number of participants with ECOG PS was reported and was measured on 6-point grade scale
0: Fully active, able to carry on all pre-disease performance without restriction
1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature
2: Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours
3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours
4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5: Dead

ECOG Perfomance Status (PS)

Study Specific Characteristic

The full analysis set (FAS) consisted of all participants who were enrolled and received at least one dose of study drug.

DLT was defined as any of the following events that occurred within 28 days starting with the first dose on cycle 1 day 1 (C1D1) and that was considered to be related to study drug. DLT was defined as follows: 

o	Grade 3 of more : non-hematologic AEs that are ≥ grade 3

o	Confirmed Hy’s law case

o	New onset of grade 4 thrombocytopenia (with minimum of 2 grade worsening from baseline) within 24 hours of dosing

o	Prolonged myelosuppression, defined as absolute neutrophil count (ANC) < 500/microliter (μL) for more than 28 days off therapy and in the absence of evidence of active leukemia or MDS in the marrow or blood.

The safety analysis set (SAF) consisted of all participants who were enrolled and received at least 1 dose of study drug.
SAF with available data was analyzed

Number of Participants with Dose Limiting Toxicities (DLTs)

TEAE

Serious TEAE

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered “serious” if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as an AE observed after starting administration of the study drug. TEAEs included both Serious and non-serious AEs.

Number of Participants with Treatment Emergent Adverse Events (TEAE) & Serious TEAE

Percentage of participants with CRc was reported. CRc:defined as rate of all complete & incomplete remissions (CR + CR with incomplete platelet recovery [CRp] + CR with incomplete hematological recover [Cri]). CR: achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If absolute neutrophil count (ANC) ≥ 1×10^9/L, platelet count (PC) ≥ 100×10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion & platelet transfusion prior to disease assessment). There was no evidence of extramedullary leukemia or Auer rods & blast counts in peripheral blood must be ≤ 2%. CRp: must achieve CR except for incomplete platelet recovery (< 100×10^9/L). CRi: must fulfil CR except for incomplete hematological recovery with residual neutropenia (ANC < 1×10^9/L), with or without complete platelet recovery. RBC and platelet transfusion independence not required.

Phase 2: Composite Complete Remission (CRc) Rate for participants with R/R AML

Percentage of participants with CR+BM CR+ PR was reported. CR, BM CR and PR achieved for minimum of 4 weeks;
CR: bone marrow: ≤ 5% myeloblasts with normal maturation of all cell Lines, peripheral blood evaluation (hemoglobin (Hb) ≥ 11 g/dL, platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood)

BM CR: bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment

PR: achieved all CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, cellularity and morphology not relevant.

Phase 2: Complete remission + bone marrow complete remission + partial remission (CR + BM CR + PR) rate for participants with R/R higher risk MDS

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale. 

0: Fully active, able to carry on all pre-disease performance without restriction.

1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5: Dead.

Number of participants with ECOG performance status at Cycle 1(C1) Day2(D2)

Number of participants with ECOG performance status at C1D4

Number of participants with ECOG performance status at C1D8

Number of participants with ECOG performance status at C1D11

Number of participants with ECOG performance status at C1D15

Grade  0

Number of participants with ECOG performance status at C1D18

Number of participants with ECOG performance status at C1D22

Number of participants with ECOG performance status at C1D25

Number of participants with ECOG performance status at C2D1

Number of participants with ECOG performance status at C2D2

Number of participants with ECOG performance status at C2D4

Number of participants with ECOG performance status at C2D8

Number of participants with ECOG performance status at C2D15

Number of participants with ECOG performance status at C2D22

Number of participants with ECOG performance status at C3D1

Number of participants with ECOG performance status at C3D15

Number of participants with ECOG performance status at C4D1

Number of participants with ECOG performance status at C4D15

Number of participants with ECOG performance status at C5D1

Gade 0

Number of participants with ECOG performance status at C5D15

Number of participants with ECOG performance status at C6D1

Number of participants with ECOG performance status at C6D15

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale. 

0: Fully active, able to carry on all pre-disease performance without restriction.

1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5: Dead.

EOT was calculated as last dose plus 7 days.

Number of participants with ECOG performance status at End of Treatment (EOT) (Dose Escalation Phase)

Number of participants with ECOG performance status at EOT (Dose Expansion Phase)

Number of participants with ECOG PS was reported. ECOG performance status was measured on a 6 point grade scale. 

0: Fully active, able to carry on all pre-disease performance without restriction.

1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5: Dead.

OP was the period observed after the last dose.

Number of participants with ECOG performance status at Observation Period (OP) (week 2)

Number of participants with ECOG performance status at OP (week 4)

Number of participants with ECOG performance status at OP (week 6)

Number of participants with ECOG performance status at OP (week 8)

Number of participants with ECOG performance status at OP (week 10)

Number of participants with ECOG performance status at OP (week 12)

Duration of CRc

Duration of CR/CRh

Duration of CRh

Duration of CR

Duration of response

DR for AML: included duration of CRc, duration of CR/complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR, and duration of response (i.e., CRc + PR).

CRh: achieved marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 × 10^9/L and platelets ≥ 50 × 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood was ≤ 2%.


PR for AML; achieved bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts with decrease of at least 50% in the percentage of blasts in bone marrow aspirate with total marrow blasts between 5% and 25%. Value ≤ 5% blasts was considered PR if Auer rods were present. No evidence of extramedullary leukemia. 

CR, CRc were defined in outcome measure #3. Kaplan Meier (KM) Estimate was used.

Response Analysis Set (RAS) included FAS participants and had at least 1 post baseline primary efficacy measurement. As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

Duration of Remission (DR)  for participants with R/R AML

Duration of Response

DR for MDS: included duration of CR and duration of response (i.e., CR + BM CR + PR).

CR, BM CR and PR achieved for minimum of 4 weeks;
CR: bone marrow: ≤ 5% myeloblasts with normal maturation of all cell Lines, peripheral blood evaluation (hemoglobin (Hb) ≥ 11 g/dL, platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood)

BM CR: bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment

PR: achieved all CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, cellularity and morphology not relevant. KM Estimate was used.

RAS
As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

Duration of Remission (DR)  for participants with R/R higher risk MDS

EFS was defined as the time from the date of first dose until the date of documented relapse, treatment failure or death from any cause within 30 days after the last dose of study drug (whichever occurred first earliest of [relapse date, treatment failure date, death date] – first dose date + 1). Relapse was defined as a reappearance of leukemic blasts in the peripheral blood (> 2%) or ≥ 5% blasts in the bone marrow aspirate not attributable to any other cause or reappearance or new appearance of extramedullary leukemia or reappearance of significant numbers of peripheral blasts and an increase in the percentage of blasts in the bone marrow aspirate to > 25% not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. KM Estimate was used.

FAS
As per change in the planned analysis, the dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

Event Free Survival (EFS)

OS was defined as the time from the date of first dose until the date of death from any cause (death date – first dose date + 1). For a Participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact – first dose date + 1). KM Estimate was used.

Overall Survival (OS)

Percentage of participants with CR  was reported. CR: achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If absolute neutrophil count (ANC) ≥ 1 × 10^9/L, platelet count (PC) ≥ 100 × 10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion & platelet transfusion prior to disease assessment). There was no evidence of extramedullary leukemia or Auer rods and blast counts in peripheral blood must be ≤ 2%.

CR for participants with R/R AML

Percentage of participants with best response (CRc + PR) was reported. CRc was defined as rate of all complete and incomplete remissions (CR + CR with incomplete platelet recovery [CRp] + CR with incomplete hematological recover [Cri]). CR, CRp and CRi were defined in Outcome measure # 3. 
PR: achieved bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts with decrease of at least 50% in the percentage of blasts in bone marrow aspirate with total marrow blasts between 5% and 25%. Value ≤ 5% blasts was considered PR if Auer rods were present. No evidence of extramedullary leukemia.

Best response (CRc + PR) rates for participants with R/R AML

Percentage of participants with CRh was reported. CRh: achieved marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 × 10^9/L and platelets ≥ 50 × 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood was ≤ 2%.

CRh for participants with R/R AML

Percentage of participants with CR was reported. CR: bone marrow: ≤ 5% myeloblasts with normal maturation of all cell Lines, peripheral blood evaluation (hemoglobin (Hb) ≥ 11 g/dL, platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L, 0% blasts in blood).

CR for participants with R/R higher risk MDS

HI - Erythroid

HI - Platelets

HI - Neutrophils

Percentage of participants with HI was reported. HI: One measurement of the following for at least 8 weeks without cytotoxic therapy: 

o	HI-erythroid: Hb increase of ≥ 1.5 g/dL or RBC transfusions performed for Hb ≤ 9.0 g/dL)

o	HI-platelets (pre-treatment PC: >20 ×10^9/L platelet, absolute increase of ≥ 30 ×10^9/L and < 20 ×10^9/L, platelet absolute increase of > 20 ×10^9/L and ≥ 100% increase from pre-treatment level

o	HI-neutrophils (increase of ≥ 100% from pre-treatment level and an absolute increase of > 0.5 ×10^9/L)