Status:
TERMINATED
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
Lead Sponsor:
Prolacta Bioscience
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a Phase 2a, open-label, multicenter study to evaluate the safety and efficacy of HMO (PBCLN-010) and B. infantis (PBCLN-014) on the gut microbiome and GI domination by pathobionts in participa...
Eligibility Criteria
Inclusion
- Signed informed consent prior to initiation of any study-specific procedure or treatment.
- Male and female participants 18 to 75 years of age at the time of informed consent.
- Planning to receive a first allo-HCT.
- Able to comply with protocol requirements.
Exclusion
- Participants with prior bowel resection resulting in colostomy
- Serious medical or psychiatric illness likely to interfere with participation in study.
- History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions.
- Female participants who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06102213
Start Date
September 18 2023
End Date
August 12 2024
Last Update
August 19 2024
Active Locations (1)
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1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030