← Back to Search

FLT Imaging for Leukemia (REALIZE Trial)

Phase 1
Recruiting
Led By Jennifer Holter, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma
Karnofsky/Lansky score of ≥ 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
Awards & highlights

REALIZE Trial Summary

This trial is looking at whether 18F FLT imaging signal uptake abnormalities can be used to detect hematopoietic malignant disease after immunotherapy and other treatments.

Who is the study for?
This trial is for people aged 4-80 with high-risk blood cancers like acute lymphocytic leukemia, who have relapsed or are not responding to treatment. They must be able to undergo FLT imaging without sedation, have certain levels of liver and kidney function, a decent quality of life score (Karnofsky/Lansky ≥ 50), and agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests whether abnormalities in FLT imaging signal uptake match up with other clinical evidence of blood cancer after treatments such as immunotherapy. Participants will either receive immunotherapy (Arm A) or non-immune therapies like chemotherapy (Arm B).See study design
What are the potential side effects?
While the side effects specific to FLT imaging aren't detailed here, typical risks may include discomfort during the procedure, allergic reactions to tracers used in imaging, and exposure to radiation.

REALIZE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood cancer has returned or is not responding to treatment.
Select...
I am able to live with some level of independence.
Select...
I can have a special type of imaging test without needing to be sedated.
Select...
I am between 4 and 80 years old.

REALIZE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A proportion of 18F FLT uptake in a standard region of interest in marrow to objectively identify disease status in patient with hematopoietic cancers.
Mean differences of 18F FLT uptake to determine extramedullary disease.
Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease.
Secondary outcome measures
Blood biomarkers
Computer assisted evaluation of leukemia and myeloma disease
Computer assisted evaluation of leukemia disease
+1 more

Side effects data

From 2014 Phase 2 trial • 26 Patients • NCT00963807
11%
Death
11%
Dyspnea
11%
Neutropenic Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)

REALIZE Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Immunotherapy - Myeloma cohortExperimental Treatment1 Intervention
The Arm will accrue patients receiving immunotherapy from the myeloma cohort (9 patients).
Group II: Immunotherapy - Acute leukemia cohortExperimental Treatment1 Intervention
The Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients).
Group III: Standard therapy - Myeloma cohortActive Control1 Intervention
The Arm will accrue patients receiving standard therapy from the myeloma cohort (9 patients).
Group IV: Standard therapy - Acute leukemia cohortActive Control1 Intervention
The Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FLT
2017
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,863 Total Patients Enrolled
Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,636 Total Patients Enrolled
Jennifer Holter, MDPrincipal InvestigatorStephenson Cancer Center
2 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

FLT Clinical Trial Eligibility Overview. Trial Name: NCT03633955 — Phase 1
Ambiguous Lineage Leukemia or Lymphoma Research Study Groups: Standard therapy - Myeloma cohort, Immunotherapy - Acute leukemia cohort, Immunotherapy - Myeloma cohort, Standard therapy - Acute leukemia cohort
Ambiguous Lineage Leukemia or Lymphoma Clinical Trial 2023: FLT Highlights & Side Effects. Trial Name: NCT03633955 — Phase 1
FLT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03633955 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment opportunities for this research venture still available?

"The data hosted on clinicaltrials.gov for this medical trial indicates that it is not accepting any more patients at the moment, as its last update was posted on February 21st 2022. However, 1691 other trials are actively seeking participants presently."

Answered by AI

May I be considered for participation in this research?

"To qualify for participation in this experiment, patients must suffer from acute myelocytic leukemia within the ages of 4 and 80. Currently, 36 individuals are being recruited by the research team."

Answered by AI

Has fludarabine-based therapy attained regulatory endorsement from the FDA?

"As this is a Phase 1 trial, meaning there are limited clinical data points related to FLT's safety and efficacy, our team at Power gave it an evaluation score of 1."

Answered by AI

Is the age restriction for this research limited to octogenarians?

"The parameters of this medical trial necessitate that all participants are aged between 4 and 80 years old. Separately, there are 497 trials for those below 18 and 1368 designed for adults above the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pilot Imaging Study of Leukemia
2023. "Pilot Imaging Study of Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03633955.
~24 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top