Automated TMLI for Acute Myeloid Leukemia

HE
Overseen ByHany Elmariah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new automated radiation treatment called VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI) for individuals with high-risk blood cancers like acute myeloid leukemia (AML). The goal is to determine if this automated approach can effectively target cancer cells while reducing side effects. Participants will receive this treatment along with a stem cell transplant. Suitable candidates include those who have had AML for some time, even after other treatments, and are considering a stem cell transplant for the first time. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from innovative therapy.

What prior data suggests that this automated TMLI technique is safe for patients with acute myeloid leukemia?

Research has shown that Total Marrow and Lymphoid Irradiation (TMLI) offers a promising treatment for high-risk blood cancers like acute myeloid leukemia. TMLI targets cancer in the bone marrow and lymph tissues while protecting the rest of the body. This approach aims to enhance treatment effectiveness and reduce side effects.

Previous studies found that TMLI, combined with chemotherapy drugs like fludarabine and cyclophosphamide, is generally well-tolerated by patients. While some side effects can occur, they are usually manageable. Earlier research supports the safety and practicality of TMLI, demonstrating a good balance between effectiveness and tolerability.

The current trial will further explore the safety of using an automated system to deliver this treatment. As a phase 2 study, existing evidence suggests the treatment is safe, but more information is needed to confirm this. Prospective participants should discuss potential risks and benefits with their healthcare provider.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a cutting-edge approach called VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI) for treating Acute Myeloid Leukemia (AML). Unlike standard treatments that often involve more generalized radiation, TMLI specifically targets bone marrow and lymphoid tissues, which could potentially reduce damage to healthy tissues and lead to fewer side effects. Additionally, the use of advanced VMAT (Volumetric Modulated Arc Therapy) allows for precise delivery of radiation, which may improve the effectiveness of the treatment. This trial could pave the way for more targeted and less harmful radiation therapy options for AML patients.

What evidence suggests that this automated TMLI technique is effective for acute myeloid leukemia?

Studies have shown that Total Marrow and Lymphoid Irradiation (TMLI) effectively targets cancer cells in the bone marrow and lymph tissues, often involved in blood cancers like acute myeloid leukemia (AML). Research indicates that combining TMLI with chemotherapy can improve outcomes for patients unresponsive to other treatments. In this trial, participants will receive TMLI as part of different conditioning regimens. One study found that 85% of patients achieved a complete response (no signs of cancer) shortly after receiving TMLI and a transplant. TMLI also causes fewer harmful side effects compared to traditional radiation treatments. These findings support TMLI's potential effectiveness in treating high-risk blood cancers like AML.678910

Who Is on the Research Team?

HE

Hany Elmariah, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with high-risk blood cancers like acute myeloid leukemia or myelodysplastic syndrome, who are healthy enough for a stem cell transplant and have an eligible donor match. Participants must meet certain health criteria and performance status.

Inclusion Criteria

I have more than 5% blasts after two or more AML treatments.
I am able to care for myself and do normal activities.
I am receiving a stem cell transplant from a donor.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive fludarabine, cyclophosphamide, and TMLI conditioning followed by allogeneic peripheral blood stem cell transplantation

Approximately 1-2 weeks

Post-transplant GVHD Prophylaxis

Participants receive post-transplant GVHD prophylaxis including cyclophosphamide, mycophenolate mofetil, and tacrolimus

Up to Day 100 post-transplant

Follow-up

Participants are monitored for safety and effectiveness after transplantation, including assessment of non-relapse mortality, neutrophil engraftment, and incidence of GVHD

100 days

What Are the Treatments Tested in This Trial?

Interventions

  • VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI)

Trial Overview

The study tests an automated radiation technique (TMLI) combined with chemotherapy drugs (fludarabine, cyclophosphamide), followed by a stem cell transplant from a donor. Additional medications help prevent complications after the transplant.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort B: Total Marrow and Lymphoid Irradiation 150 cGy BID Conditioning RegimenExperimental Treatment6 Interventions
Group II: Cohort A: Total Marrow and Lymphoid Irradiation (TMLI) 200 cGy BID Conditioning RegimenExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Total marrow irradiation for hematopoietic malignancies ...

This review focused on aspects of TMI delivery using volumetric modulated arc therapy (VMAT). In particular, multiple arcs from isocenters with different ...

Total Marrow and Lymphoid Irradiation and Chemotherapy ...

This trial tests a new treatment approach for patients with high-risk acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who haven't responded ...

192 Total Marrow and Lymphoid Irradiation TMLI at a Dose of ...

192 Total Marrow and Lymphoid Irradiation TMLI at a Dose of 2000cGy Anthony S. Stein, MD City of Hope #ASH20 #AML #AcuteMyeloidLeukemia ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28192252/

Total Marrow and Lymphoid Irradiation to Rescue ...

Total Marrow and Lymphoid Irradiation to Rescue Refractory Leukemia ... Biol Blood Marrow Transplant. 2017 Apr;23(4):536-537. doi: 10.1016/j.bbmt.2017.02.005.

Total marrow irradiation (TMI): Addressing an unmet need ...

Conclusion TMI/TMLI shows significant promise, low NRM rates, the ability to offer myeloablative radiation containing regimens to older patients ...

Protecting the Public from Foodborne Infections

The rate of acceptance can increase from 50% up to 80 meat. Irradiating ground beef would effectively destroy E. coli.

What is Food Irradiation and Why is it Important?

Food irradiation is a gentle, non-invasive technique that uses radiation to keep food fresh and safe to eat. It eliminates microbes and controls ...

Food Irradiation: What You Need to Know

The FDA approves a source of radiation for use on foods only after it has determined that irradiating the food is safe. Why Irradiate Food?

Irradiation

Irradiation is the process by which an object is exposed to radiation. An irradiator is a device used to expose an object to radiation, most often gamma ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40068595/

Low-dose irradiation of the gut improves the efficacy of PD-L1 ...

Here, we show that off-target intestinal low-dose irradiation (ILDR) increases the clinical benefits of immune checkpoint inhibitors or ...