Status:
COMPLETED
Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy
Lead Sponsor:
Notable Labs
Conditions:
Acute Myelogenous Leukemia
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and ...
Detailed Description
This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United State...
Eligibility Criteria
Inclusion
- Provide written informed consent;
- Age ≥ 18 years, male or female, of any race;
- Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy:
- Acute myelogenous leukemia (AML)
- Multiple myeloma (MM)
- Myelodysplastic syndrome (MDS)
- Lymphoma
- Acute lymphocytic leukemia (ALL)
- Chronic lymphocytic leukemia (CLL)
- Chronic myelogenous leukemia (CML)
- Neoplasm (MPN)
- Other (upon review and approval by medical monitor)
- Note: \*Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study
- Intent to start anti-cancer therapy within 21 days of biospecimen collection
- •≥7 days from last anti-cancer therapy;
- Any number of prior therapies
- Subject cohort is currently open
Exclusion
- Unwilling or unable to give consent
- Subject's disease is in remission
- Subject cohort is not open at time of consent
- Subject is restarting an ongoing treatment regimen after a dose interruption
Key Trial Info
Start Date :
December 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04014764
Start Date
December 15 2019
End Date
March 31 2022
Last Update
April 5 2022
Active Locations (20)
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1
CBCC Global Research
Bakersfield, California, United States, 93309
2
Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center
San Luis Obispo, California, United States, 93401
3
Colorado West Healthcare System, dba Grand Valley Oncology
Grand Junction, Colorado, United States, 81505
4
Ocala Oncology Center
Ocala, Florida, United States, 34474