Acute Lymphocytic LeukemiaPhase 1REALIZENCT03633955
Pilot Imaging Study of Leukemia
A Phase 1 study testing FLT in people with Acute Lymphocytic Leukemia and Acute Myeloid Leukemia, run by University of Oklahoma at 3 sites in United States.
Trial summary
This is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments. Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Ambiguous Lineage Leukemia or Lymphoma
- What is being tested?
- FLT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jan 2023to Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 4 to 80 years
- 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
- Agree to use contraceptive measures during study protocol participation (when age appropriate)
- Patient or parent/guardian capable of providing informed consent.
- Ability to undergo 18F FLT imaging without sedation
Show all 10Show fewer
- Bilirubin < 2.5 mg/dL, AST/ALT <5x upper limit of normal, Serum creatinine < 1.0 or 2x the upper limit of normal (whichever is higher)
- Pulse oximetry of > 90% on room air
- Ability to undergo 18F FLT imaging without sedation
- Anticipated immunotherapy (Arm A to include patients who received immune therapy with co-enrollment on a separate protocol or other immunotherapy) and Arm B, those who received other non-immune therapies to treat their cancers (excludes HSCT but includes chemotherapy or non-HSCT radiotherapy).
Who cannot join
- Patients with uncontrolled infections
- Pregnancy or lactating
- History of prior fluorothymidine allergy or intolerance.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Kirsten M Williams, MD
Kirsten M Williams, MD
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
Jennifer Holter Chakrabarty, MD, 405-271-4022, jholter2@ouhsc.edu
- Withdrawn
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Official title: Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
This is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
Read the detailed description
This prospective trial is designed to evaluate whether investigational 18F FLT imaging can identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis in medullary spaces) and objectively (by SUV determination).
Patients undergoing therapy for treatment of high-risk acute leukemia or myeloma will be eligible for this study. Patients may or may not have undergone myeloablative hematopoietic stem cell transplantation. Two cohorts will be accrued: patients with high risk acute leukemia and patients with myeloma. In each cohort, patients will be accrued under two arms: Arm A - patients receiving immunotherapy and Arm B - patients who are receiving standard therapy (not immunotherapy or bone marrow transplant). Therefore, the leukemia cohort will consist of patients accrued in Arm A-L (immunotherapy) or in Arm B-L (standard therapy), and the myeloma cohort will consist of patients accrued in Arm A-M (immunotherapy) or in Arm B-M (standard therapy). Because patients with high risk acute leukemia or myeloma have poor prognosis with high risk for relapse, novel ways to evaluate the success of therapies would be valuable. 18F FLT reveals hematopoietic cell proliferation and can identify residual leukemia disease. On this trial, patients will undergo 18F FLT imaging pre-therapy and during a follow-up visit post-therapy. Patients in both cohorts will be imaged (Termed baseline scan) within one week prior to receiving respective therapies (e.g. immunotherapy or standard therapy) and then imaged approximately 28 days (+/-3 days) after the therapy termed Follow-up scan. After treatment, weekly follow-ups will be conducted for these patients till the follow-up scan (28 days +/-3 days) and then the final follow-up will be conducted post-1-year (after the start of immunotherapy or standard therapy).
- Conditions
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Ambiguous Lineage Leukemia or Lymphoma, Myeloma
- Being tested
- FLT
- Keywords
- FLT
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLTDrug
F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy - Acute leukemia cohort | Active comparator | The Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients). Receives: Drug: FLT |
| Immunotherapy - Acute leukemia cohort | Experimental | The Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients). Receives: Drug: FLT |
| Standard therapy - Myeloma cohort | Active comparator | The Arm will accrue patients receiving standard therapy from the myeloma cohort (9 patients). Receives: Drug: FLT |
| Immunotherapy - Myeloma cohort | Experimental | The Arm will accrue patients receiving immunotherapy from the myeloma cohort (9 patients). Receives: Drug: FLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease.
A proportion of patients will undergo 18F FLT imaging before and after immunotherapy or standard therapy for hematopoietic malignant disease. To detect changes in the progression of hematopoietic disease 18F FLT image scans collected pre-treatment (baseline) and post-treatment (follow-up) of patient visit at OUHSC will be compared with clinically validated evidence of hematopoietic malignant disease collected using MRD, molecular, flow and histology techniques.
Measured: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
A proportion of 18F FLT uptake in a standard region of interest in marrow to objectively identify disease status in patient with hematopoietic cancers.
For proportion of patient the analyses will be compared between two Arms of disease cohort. Arm A to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT). For marrow disease, the intra-medullary pattern and standard unit of uptake (SUV) will be compared pre- and post-treatment between patients in remission clinically versus those with greater disease burden, to determine if 18F FLT uptake correlates with identified clinical relapse.
Measured: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
Mean differences of 18F FLT uptake to determine extramedullary disease.
For proportion of patient undergoing 18F FLT scan, the extramedullary disease will be identified by comparing the SUV and size of lesions pre- and post-treatment. The comparisons will be done in two arms of disease cohort Arm A, i.e., to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT).
Measured: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start19 Jan 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective pilot study, the primary aim of which is to determine whether the abnormalities in 18F FLT imaging signal uptake correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Jennifer Holter, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633955
- Sponsor's protocol ID
- OU-SCC-REALIZE
- Acronym
- REALIZE
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
- ClinicalTrials.gov ID
- NCT03633955
- Acronym / sponsor ID
- REALIZE / OU-SCC-REALIZE
- Conditions
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Ambiguous Lineage Leukemia or Lymphoma, Myeloma
- Keywords
- FLT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
Detailed description
This prospective trial is designed to evaluate whether investigational 18F FLT imaging can identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis in medullary spaces) and objectively (by SUV determination).
Patients undergoing therapy for treatment of high-risk acute leukemia or myeloma will be eligible for this study. Patients may or may not have undergone myeloablative hematopoietic stem cell transplantation. Two cohorts will be accrued: patients with high risk acute leukemia and patients with myeloma. In each cohort, patients will be accrued under two arms: Arm A - patients receiving immunotherapy and Arm B - patients who are receiving standard therapy (not immunotherapy or bone marrow transplant). Therefore, the leukemia cohort will consist of patients accrued in Arm A-L (immunotherapy) or in Arm B-L (standard therapy), and the myeloma cohort will consist of patients accrued in Arm A-M (immunotherapy) or in Arm B-M (standard therapy). Because patients with high risk acute leukemia or myeloma have poor prognosis with high risk for relapse, novel ways to evaluate the success of therapies would be valuable. 18F FLT reveals hematopoietic cell proliferation and can identify residual leukemia disease. On this trial, patients will undergo 18F FLT imaging pre-therapy and during a follow-up visit post-therapy. Patients in both cohorts will be imaged (Termed baseline scan) within one week prior to receiving respective therapies (e.g. immunotherapy or standard therapy) and then imaged approximately 28 days (+/-3 days) after the therapy termed Follow-up scan. After treatment, weekly follow-ups will be conducted for these patients till the follow-up scan (28 days +/-3 days) and then the final follow-up will be conducted post-1-year (after the start of immunotherapy or standard therapy).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a prospective pilot study, the primary aim of which is to determine whether the abnormalities in 18F FLT imaging signal uptake correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
| Arm | Type | Receives |
|---|---|---|
| Standard therapy - Acute leukemia cohort | Active comparator | Drug: FLTThe Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients). |
| Immunotherapy - Acute leukemia cohort | Experimental | Drug: FLTThe Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients). |
| Standard therapy - Myeloma cohort | Active comparator | Drug: FLTThe Arm will accrue patients receiving standard therapy from the myeloma cohort (9 patients). |
| Immunotherapy - Myeloma cohort | Experimental | Drug: FLTThe Arm will accrue patients receiving immunotherapy from the myeloma cohort (9 patients). |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 4 to 80 years
- 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
- Agree to use contraceptive measures during study protocol participation (when age appropriate)
- Patient or parent/guardian capable of providing informed consent.
Key exclusion criteria (3 listed)
- Patients with uncontrolled infections
- Pregnancy or lactating
- History of prior fluorothymidine allergy or intolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLTF18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies. | Drug | Immunotherapy - Acute leukemia cohort, Immunotherapy - Myeloma cohort, Standard therapy - Acute leukemia cohort, Standard therapy - Myeloma cohort |
Primary outcome
Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease.
Time frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
A proportion of patients will undergo 18F FLT imaging before and after immunotherapy or standard therapy for hematopoietic malignant disease. To detect changes in the progression of hematopoietic disease 18F FLT image scans collected pre-treatment (baseline) and post-treatment (follow-up) of patient visit at OUHSC will be compared with clinically validated evidence of hematopoietic malignant disease collected using MRD, molecular, flow and histology techniques.
A proportion of 18F FLT uptake in a standard region of interest in marrow to objectively identify disease status in patient with hematopoietic cancers.
Time frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
For proportion of patient the analyses will be compared between two Arms of disease cohort. Arm A to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT). For marrow disease, the intra-medullary pattern and standard unit of uptake (SUV) will be compared pre- and post-treatment between patients in remission clinically versus those with greater disease burden, to determine if 18F FLT uptake correlates with identified clinical relapse.
Mean differences of 18F FLT uptake to determine extramedullary disease.
Time frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment
For proportion of patient undergoing 18F FLT scan, the extramedullary disease will be identified by comparing the SUV and size of lesions pre- and post-treatment. The comparisons will be done in two arms of disease cohort Arm A, i.e., to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Lymphocytic Leukemia
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingPhase 3
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
B-Cell Acute Lymphoblastic Leukaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Holter, MD principal investigator
Stephenson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FLT in people with Acute Lymphocytic Leukemia and Acute Myeloid Leukemia, run by University of Oklahoma at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heme Onc Lead Nurse (1-405-271-8777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease. (time frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.