Trial Outcomes & Findings for FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT02392429)

Last Updated: 2025-09-17

Results Overview

Three imaging parameters (standardized uptake value \[SUV\]mean, SUVmax, heterogeneity of FLT uptake \[SUVhetero\]) will be measured from an FLT PET/CT scan and SUVmax will be the primary endpoint. Higher values of SUVmax assume to indicate a non-response the therapy and a cut point of 7 (SUVmax \>7) will be used as the threshold indicating a negative scan. The binomial proportion of negative predictive value (NPV) and the corresponding exact confidence intervals will be calculated. In addition, the calculated NPV will be tested against the null hypothesis to see if it's significantly larger than 0.64 (NPV of day-14 BMBX in CR prediction). CR:Complete remission CRi: Complete remission with incomplete platelet recovery LFS: Leukemia-free state Non-responders defined as Not (CR,CRi,or LFS) Negative predictive value (NPV) of the post-treatment FLT PET/CT scan is Probability ((not CR,CRi,or LFS) │ SUVmax \>7 )

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

Up to day 35

Results posted on

2025-09-17

Participant Flow

The study was activated on December 9, 2015 and finished accrual on October 16, 2018 after enrolling 87 participants from 9 institutions

Participant milestones

Participant milestones
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration Chemotherapy: Given anthracycline IV Computed Tomography: Undergo FLT PET/CT Cytarabine: Given IV Fluorothymidine F-18: Undergo FLT PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FLT PET/CT
Screening STARTED	102
Screening COMPLETED	87
Screening NOT COMPLETED	15
Enrolled Participants STARTED	87
Enrolled Participants Optional Pre-treatment FLT PET/CT	15
Enrolled Participants COMPLETED	71
Enrolled Participants NOT COMPLETED	16
Evaluable STARTED	71
Evaluable COMPLETED	61
Evaluable NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration Chemotherapy: Given anthracycline IV Computed Tomography: Undergo FLT PET/CT Cytarabine: Given IV Fluorothymidine F-18: Undergo FLT PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FLT PET/CT
Screening Screen failure	15
Enrolled Participants Ineligible due to disease	3
Enrolled Participants Withdrawal by Subject	4
Enrolled Participants Post-treatment FLT PET/CT scan not completed	9
Evaluable Death	5
Evaluable Withdrawal by Subject	1
Evaluable Adverse Event	1
Evaluable remission bone marrow biopsy	3

Baseline Characteristics

FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) n=87 Participants Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration Chemotherapy: Given anthracycline IV Computed Tomography: Undergo FLT PET/CT Cytarabine: Given IV Fluorothymidine F-18: Undergo FLT PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FLT PET/CT
Age, Continuous	59 years n=93 Participants
Sex: Female, Male Female	40 Participants n=93 Participants
Sex: Female, Male Male	47 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	77 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Leukemia classification AML with myelodysplasia-related changes	25 Participants n=93 Participants
Leukemia classification Other AML	62 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to day 35

Outcome measures

Outcome measures
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Negative n=15 Participants Patients with a Negative FLT PET (High FLT uptake defined as SUVmax \> 7)	FLT PET/CT Negative Patients with a Negative FLT PET (Negative FLT uptake defined as SUVmax \>7)
Negative Predictive Value of Post-treatment Fluorothymidine F 18 (FLT) Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging for Complete Remission (CR) in Comparison With Blast Counts From Bone Marrow Biopsy (BMBX)	0.20 Proportion of Negative scans Interval 0.04 to 0.48	—

SECONDARY outcome

Timeframe: Up to day 35

The binomial proportion of PPV and the corresponding exact confidence intervals will be calculated. In addition, the calculated PPV will be tested to see if it's significantly larger than 0.79 (PPV of day-14 BMBX in CR prediction).

Outcome measures

Outcome measures
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Negative n=46 Participants Patients with a Negative FLT PET (High FLT uptake defined as SUVmax \> 7)	FLT PET/CT Negative Patients with a Negative FLT PET (Negative FLT uptake defined as SUVmax \>7)
Positive Predictive Value (PPV) of Post-treatment FLT PET/CT Imaging for Complete Remission	0.89 Proportion of Positive Scans Interval 0.76 to 0.96	—

SECONDARY outcome

Timeframe: Up to day 35

Population: Responders: Patients with a Positive clinical response: CR, CRi, or LFS.

The binomial proportions and the corresponding exact confidence intervals will be calculated for sensitivity estimation where FLT Test : Negative: SUV \>7; Positive: SUV\<=7 Clinical Response: Negative: not (CR, CRi, or LFS); Positive (Responders): CR, CRi, or LFS

Outcome measures

Outcome measures
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Negative n=53 Participants Patients with a Negative FLT PET (High FLT uptake defined as SUVmax \> 7)	FLT PET/CT Negative Patients with a Negative FLT PET (Negative FLT uptake defined as SUVmax \>7)
Sensitivity of Post-treatment FLT PET/CT for Detecting Complete Remission (a Clinical Response of CR, CRi, or LFS )	0.77 Proportion of Responders Interval 0.64 to 0.88	—

SECONDARY outcome

Timeframe: Up to day 35

Population: Non-Responders: No Clinical Response for any of CR, CRi, or LFS.

The binomial proportions and the corresponding exact confidence intervals will be calculated for specificity estimation. Test response: Negative: SUV \>7; Positive: SUV\<=7 Clinical Response = Complete remissions: Negative (Non-Responders): not (CR, CRi, or LFS); Positive (Responders): CR, CRi, or LFS

Outcome measures

Outcome measures
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Negative n=8 Participants Patients with a Negative FLT PET (High FLT uptake defined as SUVmax \> 7)	FLT PET/CT Negative Patients with a Negative FLT PET (Negative FLT uptake defined as SUVmax \>7)
Specificity of Post-treatment FLT PET/CT for Detecting Complete Remission	0.38 Proportion of Non-Responders Interval 0.09 to 0.76	—

SECONDARY outcome

Timeframe: Up to day 35

FLT PET/CT imaging features will be compared with biologic correlates (minimal residual disease \[MRD\] assessment).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to day 35 and up to 4 years for RFS

Population: Only participants with a clinical response of CR, CRi, or LFS at the remission bone marrow biopsy (ie., where RFS is evaluable)

compare the Recurrence-Free Survival (RFS) between positive and negative post-treatment FLT PET/CT scans, where an SUVmax less than or equal to 7 (i.e., low FLT uptake) was considered a positive result, and an SUVmax greater than 7 (i.e., high FLT uptake) was a negative result. Participants were followed for survival outcomes until study closure when the last participant has been followed for 1 year after study enrollment. The relapse endpoint included both reappearance of blasts in the blood; and presence of more than 5% blasts not attributable to another cause Time-to-relapse was measured from the date of the remission bone marrow biopsy to the date of first recurrence or death, whichever came first. RFS was only evaluable for participants with a clinical response of CR, CRi, or LFS at the remission bone marrow biopsy.

Outcome measures

Outcome measures
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Negative n=41 Participants Patients with a Negative FLT PET (High FLT uptake defined as SUVmax \> 7)	FLT PET/CT Negative n=12 Participants Patients with a Negative FLT PET (Negative FLT uptake defined as SUVmax \>7)
FLT PET/CT Imaging to Predict Relapse-free Survival Recurrence	25 Participants	6 Participants
FLT PET/CT Imaging to Predict Relapse-free Survival Disease-free	16 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to day 35 and up to 4 years for RFS

Population: All participants who received an FLT PET/CT scan were included in the OS analysis,

compare the Overall Survival (OS) between positive and negative post-treatment FLT PET/CT scans, where an SUVmax\<= 7 (i.e., low FLT uptake) was considered a positive result, and an SUVmax \> 7 (i.e., high FLT uptake) was a negative result. Participants were followed for survival outcomes until study closure when the last participant has been followed for 1 year after study enrollment.

Outcome measures

Outcome measures
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) Negative n=51 Participants Patients with a Negative FLT PET (High FLT uptake defined as SUVmax \> 7)	FLT PET/CT Negative n=20 Participants Patients with a Negative FLT PET (Negative FLT uptake defined as SUVmax \>7)
FLT PET/CT Imaging to Predict Overall Survival Survivors	37 Participants	10 Participants
FLT PET/CT Imaging to Predict Overall Survival Non-survivors	14 Participants	10 Participants

Adverse Events

Diagnostic (Anthracycline, Cytarabine, FLT PET/CT)

Serious events: 24 serious events

Other events: 4 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) n=87 participants at risk Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration Chemotherapy: Given anthracycline IV Computed Tomography: Undergo FLT PET/CT Cytarabine: Given IV Fluorothymidine F-18: Undergo FLT PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FLT PET/CT
Gastrointestinal disorders Abdominal pain	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Immune system disorders Allergic reaction	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Cardiac disorders Cardiac arrest	2.3% 2/87 • Number of events 2 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
General disorders Death NOS	8.0% 7/87 • Number of events 7 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	3.4% 3/87 • Number of events 3 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Vascular disorders Hypotension	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Infections and infestations Lung infection	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
General disorders Multi-organ failure	2.3% 2/87 • Number of events 2 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Investigations Platelet count decreased	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Blood and lymphatic system disorders Progressive AML disease	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progressive disease	2.3% 2/87 • Number of events 2 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Infections and infestations Sepsis	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Nervous system disorders Stroke	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.
Cardiac disorders Troponin elevated	1.1% 1/87 • Number of events 1 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.

Other adverse events

Other adverse events
Measure	Diagnostic (Anthracycline, Cytarabine, FLT PET/CT) n=87 participants at risk Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration Chemotherapy: Given anthracycline IV Computed Tomography: Undergo FLT PET/CT Cytarabine: Given IV Fluorothymidine F-18: Undergo FLT PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FLT PET/CT
General disorders Fever	4.6% 4/87 • Number of events 4 • 5 years Within 24 hours after administration of FLT, all serious AEs worsening or emergent after FLT administration were considered reportable. After 24 hours after administration of FLT, all serious AEs that were attributed as possibly, probably, or definitely related to the study procedure were considered reportable.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60