Trial Title:
64Cu-LLP2A for Imaging Hematologic Malignancies
NCT ID:
NCT06636175
Condition:
Multiple Myeloma
Low-Grade Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Lymphoplasmacytic Lymphoma
Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Lymphoma
Multiple Myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Waldenstrom Macroglobulinemia
Lymphoma, Non-Hodgkin
Conditions: Keywords:
PET
Imaging
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
For Cohort 1B, 6 healthy volunteers and 6 patients with either multiple myeloma (MM) or
lymphoma will be recruited (healthy volunteers will be split equally with 3 men and 3
women enrolled, all efforts will be made to keep the number of subjects with MM and
lymphoma enrolled equal to Cohort 1B but it will not be a requirement).
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
64Cu-LLP2A
Description:
64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP
facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
Arm group label:
Cohort 2B: Quantitative 64Cu-LLP2A
Arm group label:
Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A
Intervention type:
Device
Intervention name:
PET/CT
Description:
The results of 64Cu-LLP2A-PET/CT will not be provided to the patient or the treating
oncologist/surgeon unless, in the judgment of the principal investigator, the images
demonstrate an unsuspected abnormality that may warrant further evaluation.
Arm group label:
Cohort 2B: Quantitative 64Cu-LLP2A
Arm group label:
Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A
Summary:
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in
healthy normal volunteers to confirm the new formulation provides comparable human
dosimetry to which was seen and published in protocol part A. Additionally, the new
formulation will be studied utilizing an expanded patient population to include patients
with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma
patients who are status post bone marrow transplant (BMT) with negative imaging and
suspected recurrence.
Criteria for eligibility:
Criteria:
Inclusion Criteria Healthy Volunteer:
- Adult 18 years of age or older
- Able to give informed consent.
- Able to comprehend and willing to follow instructions for study procedures as called
for by the protocol
- Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
- No illicit drug use or other inhaled drug use (including pharmacologic agents and
illicit drugs) within the past year per self-reporting mechanisms.
- No history of claustrophobia or other condition that has previously or would
interfere with completion of protocol specified imaging sessions.
- Not currently pregnant or nursing: Subject must be surgically sterile (has had a
documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal
(cessation of menses for more than 1 year), non-lactating, or of childbearing
potential for whom a urine pregnancy test (with the test performed within the 24
hour period immediately prior to administration of 64Cu-LLP2A) is negative.
Inclusion Criteria Hematological Malignancy:
- Clinical or pathologically defined MM or lymphoma including both newly diagnosed,
relapsed or refractory disease:
- Multiple Myeloma defined in accordance with the International Myeloma Working
Group criteria
- Low-grade lymphoma, including the following subtypes: follicular lymphoma,
marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic
lymphoma/chronic lymphocytic leukemia
- Adult 18 years of age or older and able to provide informed consent
- Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
- No history of claustrophobia or other condition that has previously or would
interfere with completion of protocol specified imaging sessions
- Not currently pregnant or nursing: Subject must be surgically sterile (has had a
documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal
(cessation of menses for more than 1 year), non-lactating, or of childbearing
potential for whom a urine pregnancy test (with the test performed within the 24
hour period immediately prior to administration of 64Cu-LLP2A) is negative
- Patients participating in imaging or therapeutic trials with investigational agents
are eligible to participate
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Contact:
Last name:
Farrokh Dehdashti, M.D.
Phone:
314-362-1474
Email:
dehdashtif@wustl.edu
Contact backup:
Last name:
Jennifer Frye, CNMT, CCRC
Phone:
314-747-1604
Email:
fryej@wustl.edu
Investigator:
Last name:
Farrokh Dehdashti, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ravi Vij, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Keith Stockerl-Goldstein, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Amanda Cashen, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mark A Schroeder, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Armin Ghobadi, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Fei Wan, Ph.D.
Email:
Sub-Investigator
Start date:
November 30, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636175
http://www.siteman.wustl.edu
