What side effects are associated with this type of intervention?

Common treatments for leukemia include chemotherapy, radiation therapy, targeted therapy, and stem cell transplants. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infections. Radiation therapy may lead to skin irritation, fatigue, and long-term risks like secondary cancers. Targeted therapies, which focus on specific molecules involved in cancer growth, can cause diarrhea, liver problems, and high blood pressure. Stem cell transplants carry risks of graft-versus-host disease, infections, and organ damage. Probiotics like Lactobacillus plantarum, used to maintain or restore gut microbiota, are generally considered safe with minimal side effects, but their efficacy and safety in leukemia treatment specifically require further research.

What prior FDA approvals exist?

The FDA has approved various treatments for leukemia, including chemotherapy agents, targeted therapies, immunotherapies, and stem cell transplants. Some notable drugs include imatinib (Gleevec) for chronic myeloid leukemia, and blinatumomab (Blincyto) for acute lymphoblastic leukemia. While these treatments focus on directly targeting cancer cells, there is growing interest in using probiotics to maintain or restore gut microbiota, especially in patients undergoing intensive treatments like stem cell transplants. Probiotics such as Lactobacillus plantarum are being studied for their potential to prevent complications like graft-versus-host disease by promoting a healthy gut microbiome.

What other types of research exist?

Promising alternatives to Lactobacillus plantarum for leukemia patients include Lactobacillus reuteri and Lactobacillus rhamnosus GG. These probiotics have shown potential in maintaining gut health and modulating the immune system, which could be beneficial for leukemia patients undergoing treatment.

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Probiotic

Probiotics for Preventing Graft-versus-Host Disease

Phase 3

Waitlist Available

Led By Michael L Nieder

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant

Be younger than 65 years old

Must not have

Patient plans on receiving stem cells from a matched (8/8) related donor

Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn's disease, ulcerative colitis), history of gastrointestinal GVHD, or history of bowel resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 days post stem cell infusion

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether Lactobacillus plantarum, a beneficial bacteria found in foods like yogurt, can prevent a serious gut complication called acute graft versus host disease in young patients receiving stem cell transplants. The bacteria may help by keeping the gut healthy and reducing inflammation. Lactobacillus plantarum has been used in human studies to promote beneficial effects in the immune system, alleviate intestinal disorders, and reduce the risk of cardiovascular disease. The study will compare patients taking Lactobacillus plantarum to those not taking it.

Who is the study for?

This trial is for children with leukemia, lymphoma, or other blood cancers who are undergoing a donor stem cell transplant. They must have good performance status and be receiving cells from a partially matched donor. Kids can't join if they're allergic to certain antibiotics, recently took probiotics, are pregnant, have active infections or severe GI issues.

What is being tested?

The study tests whether Lactobacillus plantarum strains (299 and 299v) can prevent acute graft versus host disease in the gut after stem cell transplants compared to a placebo. It's randomized: patients don't choose which treatment they get.

What are the potential side effects?

Possible side effects may include reactions related to gut health since Lactobacillus plantarum is involved with gastrointestinal function. Specific side effects will depend on how each child's body responds to the bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with a condition treated by a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I plan to receive stem cells from a fully matched family member.

Select...

I have had severe gastrointestinal problems or surgeries in the past.

Select...

I am not pregnant and have a negative pregnancy test.

Select...

I am allergic to specific antibiotics used for treating blood infections.

Select...

I currently have diarrhea that tested positive for C. difficile.

Select...

I am currently on antibiotics for a bacterial infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 days post stem cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 days post stem cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days post stem cell infusion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Participants With Stage 1-4 Gastrointestinal (GI) Acute Graft Versus Host Disease (aGVHD)

Other study objectives

Bacterial Genes and Pathways, and Bacterial Metabolites (Blood/Stool Measures of Intestinal Flora - Function and Phylogenetic Composition)

Blood/Stool Measures of Intestinal Flora Assessed Using Sequencing

Hospital Days

+6 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (Lactobacillus plantarum, alloHCT)Experimental Treatment3 Interventions

Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.

Group II: Arm II (placebo, alloHCT)Placebo Group2 Interventions

Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240

0 / 7Eligibility criteria met

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 leukemia include chemotherapy, which uses drugs to kill rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in cancer cell growth; immunotherapy, which boosts the body's immune system to fight cancer; and stem cell transplants, which replace diseased bone marrow with healthy cells. These treatments are crucial for leukemia patients as they aim to eliminate cancer cells, restore normal blood cell production, and prevent relapse. While probiotics like Lactobacillus plantarum are not directly used to treat leukemia, maintaining a healthy gut microbiota can support overall health and potentially improve the immune system's function, which is beneficial during cancer treatment.