Acute Lymphoblastic Leukemia (ALL) Clinical Trials

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Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging

Who is this study for? Patients with acute leukemia
What treatments are being studied? FLT
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 cancers (excludes HSCT but includes chemotherapy or non-HSCT radiotherapy).

Locations
United States
Washington, D.c.
Children's National Health System
WITHDRAWN
Washington D.c.
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Contact Information
Primary
Heme Onc Lead Nurse
SCC-IIT-Office@ouhsc.edu
1-405-271-8777
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2028-04
Participants
Target number of participants: 60
Treatments
Active_comparator: Standard therapy - Acute leukemia cohort
The Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients).
Experimental: Immunotherapy - Acute leukemia cohort
The Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients).
Active_comparator: Standard therapy - Myeloma cohort
The Arm will accrue patients receiving standard therapy from the myeloma cohort (9 patients).
Experimental: Immunotherapy - Myeloma cohort
The Arm will accrue patients receiving immunotherapy from the myeloma cohort (9 patients).
Sponsors
Collaborators: Emory University
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov