CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant

NCT03922035 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 18193NCI-2018-01886
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial studies the side effects and how well CBM588 works in improving clinical outcomes in patients who have undergone donor hematopoietic stem cell transplant. Gut microbiota (formerly called gut flora) is the name given to the microbe (bacteria) population living in the intestine. Gut bacteria help the body to digest certain foods that the stomach and small intestine have not been able to digest. CBM588, may increase gut bacteria biodiversity, prevent recurrent symptoms of gastrointestinal toxicity (ranging from diarrhea to life-threatening inflammation of the colon).

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Will be scored according to the modified Bearman Scale and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 scale. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

  From initiation of treatment until end of treatment assessed up to 100 days

• Feasibility of CBM588

  Will be evaluated by assessment of patients' ability to take half of the specified dose.

  During the safety lead-in phase

Secondary Outcomes (6)

• Incidence and severity of adverse events

  Up to 2 years

• Overall survival

  Up to 2 years

• Cumulative incidence (CI) of chronic graft versus host disease (cGVHD)

  Up to 2 years

• CI of acute graft versus host disease (aGVHD)

  Up to 2 years

• CI of relapse/progression of disease

  Up to 2 years

Other Outcomes (5)

• Gut microbiome diversity

  Up to 2 years

• Gut microbiome diversity and bloodstream infection

  Up to 2 years

• Gut microbiome diversity aGVHD incidence

  Up to 2 years

Study Arms (2)

Arm I (CBM588)

EXPERIMENTAL

Patients receive standard peri-/post-transplant supportive care and CBM588 PO BID from day of admission to day 28 in the absence of disease progression or unacceptable toxicity.

Other: Best Practice; Drug: Clostridium butyricum CBM 588 Probiotic Strain

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard peri-/post-transplant supportive care.

Other: Best Practice

Interventions

Best Practice OTHER

Receive standard peri-/post-transplant supportive care

Also known as: standard of care, standard therapy

Arm I (CBM588); Arm II (standard of care)

Clostridium butyricum CBM 588 Probiotic Strain DRUG

Given PO

Also known as: C. butyricum CBM 588 Probiotic Strain, C. butyricum MIYAIRI Strain, C. butyricum Strain MIYAIRI 588, CBM 588, CBM588, Clostridium butyricum MIYAIRI 588, Clostridium butyricum MIYAIRI 588 Probiotic Strain, MIYAIRI 588, MIYAIRI 588 Strain of C. butyricum

Arm I (CBM588)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative.
• Assent, when appropriate, will be obtained per institutional guidelines.
• Willingness to be followed for the planned duration of the trial (2 years).
• Karnofsky performance status must be \>= 60%.
• Any hematologic disorders receiving allogeneic hematopoietic stem cell transplant with reduced intensity conditioning.
• Planned 8/8 or 7/8 (human leukocyte antigens \[HLA\]-A, B, C, DR) related or unrelated donor hematopoietic cell transplantation (HCT).
• Clinical Laboratory and Organ Function Criteria: Consistent with City of Hope (COH) standard operating procedure (SOP) for "patient evaluation for selection for hematopoietic cell transplantation.
• Patient is eligible to receive allogeneic hematopoietic cell transplantation with reduced intensity conditioning.
• Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy.
• Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).

You may not qualify if:

• Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study. A legal guardian may substitute for the research participant.
• Refusing to use contraception up to 90 days post-HCT.
• Pregnant and/or breast feeding if a female recipient.
• Patients with history of chronic intestinal disease (e.g., Crohn's disease, ulcerative colitis).
• In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment.
• Research participants receiving any other investigational agents.
• Known or documented history of hypersensitivity to all the listed antibiotics, used for severe infections related to CBM588:
• Ampicillin.
• Chloramphenicol.
• Clindamycin.
• Erythromycin.
• Metronidazole.
• Tetracycline.
• Vancomycin.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (i.e., research participants whom are severe lactose intolerance or intolerance to milk products).

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Ryotaro Nakamura

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: April 19, 2019
• Study Start: April 18, 2019
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

US (1)