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Radiation

Targeted Total Marrow Irradiation for Leukemia

Phase 2
Recruiting
Led By Pritesh Patel, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate end-organ function as measured by:
Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (> 3 abnormalities), inv(3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will use a new treatment for leukemia that includes targeted total marrow irradiation and graft-versus-host disease prophylaxis.

Who is the study for?
Adults aged 18-75 with certain types of leukemia or myelodysplastic syndrome, who haven't responded well to other treatments and need frequent transfusions. They must have a related donor that's at least half-matched genetically, or an unrelated donor with specific mismatches. Participants should be in decent health otherwise, without serious liver issues or heart and lung function below half the normal level.Check my eligibility
What is being tested?
The trial is testing a pre-transplant conditioning process using targeted total marrow irradiation (TMI) at a dose of 6Gy. After transplant, patients will receive cyclophosphamide along with tacrolimus and mycophenolate mofetil to prevent graft-versus-host disease.See study design
What are the potential side effects?
Possible side effects include damage to organs from radiation, complications from immune suppression such as infections or reaction against host tissues by the graft (graft-versus-host disease), plus typical chemotherapy-related issues like nausea, fatigue, blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vital organs are functioning well.
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My cancer has specific genetic features considered high-risk.
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My cancer has high-risk genetic features like the FLT3 mutation.
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I was diagnosed with MDS before turning 21.
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My acute lymphoblastic leukemia is in its first remission and is considered high risk.
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My donor matches me in at least half of the required genetic markers.
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My leukemia is Philadelphia-like ALL.
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My leukemia has returned or didn't respond to treatment.
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My cancer has high-risk genetic features.
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I am older than 35.
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My MDS has at least one high-risk feature.
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I need blood transfusions more than once a week due to severe blood cell shortages.
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I have a bone marrow disorder related to previous cancer treatment.
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My leukemia is of a mixed or dual type.
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My diagnosis is listed as eligible for the trial.
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My cancer has specific genetic features considered high-risk.
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I am between 18 and 75 years old.
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My AML is in its first remission and is considered high-risk.
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My condition did not improve after DNA-methyltransferase inhibitor therapy.
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My AML developed from a previous blood disorder.
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My cancer has high-risk genetic features like BCOR or p53 mutations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft-vs-Host Disease
Rate of 1 year Graft-Versus-Host Disease (GVHD) relapse free survival
Secondary outcome measures
Engraftment rates
Rates of incidence of full donor chimerism
The number of patients with greater than or equal to grade 4 non-hematologic toxicities
+6 more

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
605 Previous Clinical Trials
1,559,218 Total Patients Enrolled
Pritesh Patel, MDPrincipal InvestigatorUniversity of Illinois at Chicago
3 Previous Clinical Trials
18 Total Patients Enrolled
Rondelli Damiano, MDPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Total Marrow Irradiation (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04187105 — Phase 2
Acute Leukemia Research Study Groups:
Acute Leukemia Clinical Trial 2023: Total Marrow Irradiation Highlights & Side Effects. Trial Name: NCT04187105 — Phase 2
Total Marrow Irradiation (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04187105 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on participants in this clinical trial?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, which was first uploaded on January 27th 2020 is currently searching for participants to join the study. The total number of patients needed are 27, who will be recruited from one medical facility."

Answered by AI

What key aims is this clinical trial attempting to attain?

"Over the course of a year, this clinical trial will primarily measure GVHD relapse-free survival. Secondary metrics include event free-survival (EFS), progression at one year post transplantation and engraftment rates 30 days into the study."

Answered by AI

Am I eligible to join the investigation?

"This clinical trial is seeking 27 leukemia patients, ranging in age from 18 to 75 years old. In accordance with the protocol requirements, participants must possess a related donor who shares at least one allele of each HLA loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLADQB1; alternatively an unrelated donor that mismatches at least one of these loci will be accepted as long as they share 5/10 genetic markers. Additionally applicants should have relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia"

Answered by AI

Are participants being accepted for this study at the current time?

"Clinicaltrials.gov reveals that recruitment for this trial is ongoing and has been since the study was first published on January 27th 2020, with a final update taking place October 13th 2022."

Answered by AI

What potential risks might be associated with this particular treatment?

"The perceived safety of this treatment has been rated at a 2 by Power, as the Phase 2 trial only provides evidence for its security and not its efficacy."

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Is the study recruiting participants who are 45 years of age and older?

"The age cutoff for this trial is 18 years old and 75, as dictated by the requirements listed in the eligibility criteria."

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~3 spots leftby Nov 2024