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

National Cancer Institute (NCI)

Status and phase

Active, not recruiting

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Procedure: Bone Marrow Aspiration

Drug: Chemotherapy

Procedure: Positron Emission Tomography

Other: Fluorothymidine F-18

Other: Laboratory Biomarker Analysis

Procedure: Bone Marrow Biopsy

Procedure: Computed Tomography

Drug: Cytarabine

Procedure: Biospecimen Collection

Study type

Interventional

Funder types

NIH

Identifiers

NCT02392429

NCI-2015-00328 (Registry Identifier)

U10CA180820 (U.S. NIH Grant/Contract)

EAI141

U10CA180827 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

87 participants in 1 patient group

Diagnostic (anthracycline, cytarabine, FLT PET/CT)

Experimental group

Description:

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.

Treatment: