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New treatment option for Acute Lymphocytic Leukemia
Official title Pilot Imaging Study of Leukemia
ClinicalTrials.gov ID: NCT03633955
What this study is testing
What is FLT?
FLT is an investigational medicine, given as an once-weekly, being studied as a potential treatment for acute lymphocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 80
You may be able to join if
- Aged 4 to 80 years
- Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous...
- 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.
You likely can't join if
- Patients with uncontrolled infections
- Pregnancy or lactating
- History of prior fluorothymidine allergy or intolerance.
See the full eligibility criteria
- 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
- 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...
- Patients with uncontrolled infections
- Pregnancy or lactating
- History of prior fluorothymidine allergy or intolerance.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.