Clinical trial NCT06636175: 64Cu-LLP2A for Imaging Hematologic Malignancies
Official title: Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma
Low-Grade Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Lymphoplasmacytic Lymphoma
Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia
Keywords: PET
Imaging
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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

Primary outcomes:
measure: Organ dosimetry of participants
timeFrame: Through completion of PET/CT scans (estimated to be up to 2 days)
measure: Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events
timeFrame: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)
Secondary outcomes:
measure: Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images
timeFrame: Through completion of PET/CT scans (estimated to be up to 2 days)
measure: Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake
timeFrame: Through completion of PET/CT scans (estimated to be up to 2 days)
measure: Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio
timeFrame: Through completion of PET/CT scans (estimated to be up to 2 days)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Farrokh Dehdashti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: