Hematopoietic and Lymphoid Cell NeoplasmPhase 1NCT03922035
CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant
A Phase 1 study testing Best Practice and Clostridium butyricum CBM 588 Probiotic Strain in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Best Practice and Clostridium butyricum CBM 588 Probiotic Strain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 5 Feb 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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.
- Research participants with presence of other active malignancy within 2 years of study entry. Participants with history of prior malignancy treated with curative intent who achieved complete response (CR) more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer.
- 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).
- Research participants having any uncontrolled illness including ongoing or active infection. Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections.
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Randomized Open Label Pilot Study of Clostridium Butyricum MIYAIRI 588 (CBM588) in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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).
Read the detailed description
PRIMARY OBJECTIVES:
- In patients with hematologic malignancies who are undergoing standard reduced intensity conditioning regimen (RIC) prior to allogeneic stem cell transplantation, to evaluate the safety and feasibility of Clostridium butyricum CBM 588 probiotic strain (CBM588) treatment by assessing:
Ia. Type, frequency, severity, attribution, time course and duration of adverse events, including diarrhea, bloodstream/intestinal infections.
Ib. Patient compliance, the patients' ability to take CBM588 during the treatment period.
SECONDARY OBJECTIVES:
- Compare the incidence and severity of adverse events (AE) among CBM588-treated and untreated patients, including diarrhea, bloodstream infections and intestinal infections.
II. Estimate overall survival (OS), cumulative incidence (CI) of chronic graft versus host disease (GVHD), relapse/progression, and non-relapse mortality (NRM) at 100 days, 6 months, 1 year and 2 years.
EXPLORATORY OBJECTIVES:
- Compare gut microbiome diversity among CBM588-treated/untreated patients. II. Obtain a preliminary estimate of the possible association between gut microbiome diversity and bloodstream infections.
III. Characterize and compare graft versus host disease (GVHD) inflammatory biomarkers (presence, level) among CBM588-treated and untreated patients.
IV. Obtain preliminary estimates of gut microbiome diversity, as assessed by the inverse Simpson Index, in CBM588-treated/untreated patients.
- Obtain a preliminary estimate of the possible association between gut microbiome diversity and acute GVHD cumulative incidence, including time to onset.
VI. Characterize and compare urinary uindoxyl sulfate, tryptophan and kynurenine levels between CBM588- treated and untreated patients.
VII. To obtain a preliminary estimate of gut microbiome diversity and calorie intake.
VIII. Characterize and compare impact of CBM588 administration on regulatory T cells (T regs) reconstitution between CBM588-treated and untreated patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (CBM588): Patients receive standard peri-/post-transplant supportive care and CBM588 orally (PO) twice daily (BID) from day of admission to day 28 in the absence of disease progression or unacceptable toxicity.
ARM II (STANDARD OF CARE): Patients receive standard peri-/post-transplant supportive care.
After completion of study treatment, patients are followed up for 100 days and then up to 2 years.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Best Practice, Clostridium butyricum CBM 588 Probiotic Strain
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard peri-/post-transplant supportive care
Clostridium butyricum CBM 588 Probiotic StrainDrug
Also called C. butyricum CBM 588 Probiotic Strain, C. butyricum MIYAIRI Strain, C. butyricum Strain MIYAIRI 588, CBM 588
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the safety lead-in phase
Secondary outcomes (6)
Incidence and severity of adverse events
Assessed by modified Bearman criteria and NCI CTCAE version 5 scale. Will be compared among CBM588 treated and untreated patients.
Measured: Up to 2 years
Overall survival
Will be estimated using the product-limit method of Kaplan and Meier.
Measured: Up to 2 years
Cumulative incidence (CI) of chronic graft versus host disease (cGVHD)
Will be estimated using the method described by Gooley et al (1999).
Measured: Up to 2 years
CI of acute graft versus host disease (aGVHD)
Will be estimated using the method described by Gooley et al (1999).
Measured: Up to 2 years
CI of relapse/progression of disease
Will be estimated using the method described by Gooley et al (1999).
Measured: Up to 2 years
Non-relapse mortality
Will be estimated using the method described by Gooley et al (1999).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start17 Jun 2019
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryotaro Nakamura, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922035
- Sponsor's protocol ID
- 18193
- Other IDs
- NCI-2018-01886, 18193
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2018
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No