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FLT PET/CT zur Messung des Ansprechens bei Patienten mit zuvor unbehandelter akuter myeloischer Leukämie

22. September 2026 aktualisiert von: National Cancer Institute (NCI)

Frühzeitige Beurteilung des Behandlungsansprechens bei AML mit FLT-PET/CT-Bildgebung

This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVES:

I. To evaluate the negative predictive value (NPV) of post-treatment FLT PET/CT imaging for complete remission (CR) in patients receiving induction chemotherapy for acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. To evaluate the positive predictive value (PPV) of post-treatment FLT PET/CT imaging for complete remission.

II. To estimate the sensitivity and specificity of post-treatment FLT PET/CT imaging for detecting complete remission.

III. To correlate FLT PET/CT imaging with biologic correlates (minimal residual disease [MRD] assessment) IV. To correlate FLT PET/CT imaging with relapse-free survival and overall survival.

EXPLORATORY OBJECTIVES:

III. To evaluate pre-treatment FLT PET/CT imaging as a predictor of complete remission.

IV. To evaluate the change between pre-treatment and post-treatment FLT PET/CT imaging as a predictor of complete remission.

OUTLINE:

Patients receive anthracycline intravenously (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.

After completion of study, patients are followed up at day 28-35, and then up to 1 year beyond the end of study accrual period.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

87

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Mayo Clinic in Rochester
    • Missouri
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania/Abramson Cancer Center
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84112
        • Huntsman Cancer Institute/University of Utah
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients must have previously untreated AML and be candidates for intensive induction chemotherapy; patients are allowed to have had prior hydroxyurea
  • Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)
  • Patients must have left ventricular ejection fraction (LVEF) > 45% or within institutional normal limits
  • Patients must be able to lie still for a 1.5 hour PET scan
  • Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine
  • Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center
  • The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined
  • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Laboratory Biomarker Analysis

Correlative studies

Arzneimittel: Cytarabine

Given IV

Andere Namen:
  • Β-Cytosinarabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-Arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-Pyrimidinon, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinon, 4-Amino-1β-D-arabinofuranosyl-
  • Alexander
  • Ara-C
  • ARA-Zelle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin-Arabinosid
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinosid
  • Cytosin-β-arabinosid
  • Cytosin-beta-Arabinosid
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Verfahren: Biospecimen Collection

Undergo blood sample collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Verfahren: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Verfahren: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Arzneimittel: Chemotherapy

Given anthracycline IV

Andere Namen:
  • Chemo
  • Chemotherapie (NOS)
  • Chemotherapie, Krebs, Allgemein
Verfahren: Computed Tomography

Undergo FLT PET/CT

Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Sonstiges: Fluorothymidine F-18

Undergo FLT PET/CT

Andere Namen:
  • 18F-FLT
  • 3'-Desoxy-3'-[18F]fluorthymidin
  • 3'-Desoxy-3'-(18F)-Fluorthymidin
  • Fluorthymidin F 18
  • ALOVUDINE F-18
Verfahren: Positron Emission Tomography

Undergo FLT PET/CT

Andere Namen:
  • Medizinische Bildgebung, Positronen-Emissions-Tomographie
  • HAUSTIER
  • PET-Scan
  • Positronen-Emissions-Tomographie-Scan
  • Positronen-Emissions-Tomographie
  • Pt
  • Positronen-Emissions-Tomographie (Verfahren)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: Up to day 35

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 )
Up to day 35

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Positive Predictive Value (PPV) of Post-treatment FLT PET/CT Imaging for Complete Remission
Zeitfenster: 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).
Up to day 35
Sensitivity of Post-treatment FLT PET/CT for Detecting Complete Remission (a Clinical Response of CR, CRi, or LFS )
Zeitfenster: Up to day 35

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
Up to day 35
Specificity of Post-treatment FLT PET/CT for Detecting Complete Remission
Zeitfenster: Up to day 35

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
Up to day 35
FLT PET/CT Imaging Parameters With Biologic Correlates (Minimal Residual Disease Assessment)
Zeitfenster: Up to day 35

FLT PET/CT imaging features will be compared with biologic correlates (minimal residual disease [MRD] assessment).
Up to day 35
FLT PET/CT Imaging to Predict Relapse-free Survival
Zeitfenster: Up to day 35 and up to 4 years for RFS

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.
Up to day 35 and up to 4 years for RFS
FLT PET/CT Imaging to Predict Overall Survival
Zeitfenster: Up to day 35 and up to 4 years for RFS

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.
Up to day 35 and up to 4 years for RFS

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Robert Jeraj, ECOG-ACRIN Cancer Research Group

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. April 2016

Primärer Abschluss (Tatsächlich)

31. Dezember 2023

Studienabschluss (Geschätzt)

13. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

18. März 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. März 2015

Zuerst gepostet (Geschätzt)

19. März 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NCI-2015-00328
  • U10CA180820 (US NIH Stipendium/Vertrag)
  • NCI-2015-00328 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • EAI141 (Andere Kennung: CTEP)
  • U10CA180827 (US NIH Stipendium/Vertrag)
  • EAI141
  • EAI141 (Andere Kennung: ECOG-ACRIN Cancer Research Group)

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