What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as chemotherapy and stem cell transplants, often result in a range of side effects. These can include gastrointestinal issues like nausea, diarrhea, and life-threatening inflammation of the colon. Other frequent side effects are hematologic toxicities such as anemia, neutropenia, and thrombocytopenia, as well as infections due to weakened immune systems. Treatments like CBM588, which aim to increase gut bacteria biodiversity, are being studied to mitigate some of these gastrointestinal toxicities.

What prior FDA approvals exist?

FDA approvals for blood cancer treatments have included various targeted therapies and immunotherapies. For example, ibrutinib, a Bruton's tyrosine kinase inhibitor, has been approved for chronic lymphocytic leukemia (CLL) and other blood cancers. Venetoclax, a BCL-2 inhibitor, is another approved drug for CLL. While these treatments do not specifically focus on gut bacteria biodiversity like CBM588, they represent significant advancements in targeted therapy for blood cancers. There is limited information on FDA-approved treatments that directly increase gut bacteria biodiversity to prevent gastrointestinal toxicity in blood cancer patients.

What other types of research exist?

Promising alternatives to CBM588 for blood cancer patients include: 1) Probiotics such as Lactobacillus and Saccharomyces boulardii, which have shown effectiveness in preventing Clostridium difficile-associated diarrhea and rebalancing intestinal microbiota. 2) Fidaxomicin, which has been studied for prophylaxis of Clostridium difficile-associated diarrhea in patients undergoing hematopoietic stem cell transplantation. 3) Clostridium difficile toxoid vaccines, which have demonstrated safety and immunogenicity in preventing recurrent C. difficile-associated diarrhea.

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CBM588 Probiotic for Blood Cancer Post-Transplant Care

Phase 1

Waitlist Available

Led By Ryotaro Nakamura

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a drug to help improve outcomes for people who have had a stem cell transplant from a donor. The drug may help increase gut bacteria biodiversity and prevent recurrent gastrointestinal symptoms.

Who is the study for?

This trial is for patients with blood cancers who are undergoing a donor stem cell transplant. They must be willing to follow the trial for 2 years, have a performance status of at least 60%, and agree to use birth control. Excluded are pregnant or breastfeeding women, those with chronic intestinal diseases, severe allergies to certain antibiotics, uncontrolled illnesses like active infections or hepatitis B/C, HIV positive individuals, other active malignancies within the last 2 years (except certain skin cancers and cervical cancer in-situ), or severe lactose intolerance.Check my eligibility

What is being tested?

The trial tests CBM588 probiotic strain's effectiveness in improving gut bacteria diversity and preventing gastrointestinal issues after stem cell transplants. It's compared against standard practices in patients who've had reduced intensity conditioning before their transplant.See study design

What are the potential side effects?

Potential side effects may include digestive disturbances such as diarrhea due to changes in gut microbiota from taking CBM588. Since it aims to prevent inflammation of the colon and other GI toxicity symptoms post-transplant, fewer serious side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of CBM588

Incidence of adverse events

Secondary outcome measures

CI of acute graft versus host disease (aGVHD)

CI of relapse/progression of disease

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

+3 more

Other outcome measures

Gut microbiome diversity

Gut microbiome diversity aGVHD incidence

Gut microbiome diversity and bloodstream infection

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (CBM588)Experimental Treatment2 Interventions

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.

Group II: Arm II (standard of care)Active Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also harm healthy cells, leading to side effects like gastrointestinal toxicity. Targeted therapies, such as tyrosine kinase inhibitors, specifically target cancer cell pathways, reducing damage to normal cells. Immunotherapy boosts the body's immune system to fight cancer. The CBM588 trial focuses on increasing gut bacteria biodiversity to prevent gastrointestinal toxicity, which is crucial for blood cancer patients as it can improve their overall treatment tolerance and quality of life by reducing one of the significant side effects of conventional therapies.

Towards Taming the Bugs to Improve the Drugs for Breast Cancer.Haematology.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,717 Previous Clinical Trials

40,953,328 Total Patients Enrolled

1 Trials studying Blood Cancers

70 Patients Enrolled for Blood Cancers

City of Hope Medical CenterLead Sponsor

570 Previous Clinical Trials

1,922,580 Total Patients Enrolled

Ryotaro NakamuraPrincipal InvestigatorCity of Hope Medical Center

5 Previous Clinical Trials

216 Total Patients Enrolled

Media Library

Clostridium butyricum CBM 588 Probiotic Strain Clinical Trial Eligibility Overview. Trial Name: NCT03922035 — Phase 1

Blood Cancers Research Study Groups: Arm I (CBM588), Arm II (standard of care)

Blood Cancers Clinical Trial 2023: Clostridium butyricum CBM 588 Probiotic Strain Highlights & Side Effects. Trial Name: NCT03922035 — Phase 1

Clostridium butyricum CBM 588 Probiotic Strain 2023 Treatment Timeline for Medical Study. Trial Name: NCT03922035 — Phase 1

~3 spots leftby Dec 2024

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