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

No Placebo-Only Group

Summary

This trial studies how well a probiotic called CBM588 works in patients who have had a stem cell transplant. These patients often have gut problems and infections. CBM588 aims to increase the variety of good bacteria in their intestines to help with digestion and reduce harmful side effects. Clostridium butyricum MIYAIRI 588 (CBM 588) is a probiotic strain developed for use by humans and animals, known for its beneficial health effects and safety profile.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of CBM588

Incidence of adverse events

Secondary study objectives

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 study objectives

Gut microbiome diversity

Gut microbiome diversity aGVHD incidence

Gut microbiome diversity and bloodstream infection

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clostridium butyricum CBM 588 Probiotic Strain

2019

Completed Phase 1

~30

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.