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Alkylating agents

IM-TMI + Chemotherapy for AML and MDS

Phase 2

Recruiting

Led By Damiano Rondelli, 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

Age 18-65 years

Patients with AML or MDS meeting specific criteria including relapsed or refractory AML, poor-risk AML in first remission, primary refractory disease, MDS with poor-risk features, and CML with a history of accelerated or blast phase

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing whether adding a new kind of radiation to the standard myeloablative fludarabine/ i.v. targeted busulfan conditioning improves outcomes for patients receiving allogeneic hematopoietic stem cell transplant (HSCT).

Who is the study for?

This trial is for adults aged 18-65 with high-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS), including those with specific genetic mutations, poor response to prior treatments, or severe blood cell shortages. Participants need a compatible stem cell donor and must be in relatively good health without serious heart, liver, lung conditions, active infections like hepatitis or HIV, and not pregnant.Check my eligibility

What is being tested?

The study tests adding Intensity Modulated Total Marrow Irradiation (IM-TMI) at a dose of 9 Gy to the standard Fludarabine/Busulfan conditioning before allogeneic hematopoietic stem cell transplant. This Phase II trial aims to see if this combination improves outcomes for patients with high-risk AML/MDS.See study design

What are the potential side effects?

Potential side effects include damage to bone marrow resulting in low blood counts; organ toxicity affecting the heart, lungs, liver; increased risk of infections due to immune suppression; mouth sores from chemotherapy; and complications related to stem cell infusion.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My leukemia or myelodysplastic syndrome is in a difficult-to-treat stage or has returned after treatment.

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I have a stem cell donor who matches the required HLA criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

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

Relapse free survival of approximately 30% in high-risk patients conditioned with the Fludarabine/ Busulfan regimen

Secondary outcome measures

Overall survival

Relapse free survival

Transplant related mortality rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patient TreatmentExperimental Treatment7 Interventions

Patients will receive fludarabine 40 mg/m2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2, IV busulfan targeting a 4800μM/min/ day from day -5 through day -2, and ATG (Thymoglobulin®) at 0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1 (Only for recipients of stem cells from unrelated or mismatched donors). In addition to the above conditioning regimen all patients will receive TMI at a dose of 3Gy on days -3, -2 and -1. On day 0, the stem cell product will be infused according to BMT unit policy. Graft versus host disease (GVHD) prophylaxis will consist of administration of tacrolimus and methotrexate. Post-transplant evaluation will be done as per standard care with study data collected at day 30, 60, 90, 180, 365 and 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total Marrow Irradiation

2014

Completed Phase 1

~20

Fludarabine

2012

Completed Phase 3

~1100

ATG

2016

Completed Phase 4

~1070

Tacrolimus

2011

Completed Phase 4

~4740

Methotrexate

2013

Completed Phase 4

~3800

Busulfan

2008

Completed Phase 3

~1120

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,271 Total Patients Enrolled

Damiano Rondelli, MDPrincipal Investigator - University of Illinois at Chicago

University of Illinois at Chicago Eye & Ear Infirmary

6 Previous Clinical Trials

247 Total Patients Enrolled

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03121014 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Patient Treatment

Acute Myeloid Leukemia Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT03121014 — Phase 2

Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03121014 — Phase 2

Frequently Asked Questions

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

For whom is enrollment in this clinical trial open?

"This medical study requires that the participants have myelodysplastic syndromes and are within 18 to 65 years old. The total number of patients required for this trial is 38."

Answered by AI

What maladies does Fludarabine typically address?

"Fludarabine is typically used to combat dermatitis, atopic. This medication may also be employed to address additional illnesses such as multiple sclerosis, advance directives, and psoriasis."

Answered by AI

What adverse effects could be associated with Fludarabine use?

"Our team at Power has rated Fludarabine a 2 on the safety scale as there is limited clinical evidence supporting its efficacy, but some data indicating that it can be safe to use."

Answered by AI

Are there any opportunities available for patients to participate in this research endeavor?

"Clinicaltrials.gov confirms that this medical study is actively recruiting participants, having been initially posted to the site on April 24th 2017 and most recently updated June 15th 2022."

Answered by AI

How many participants has this experiment been limited to?

"Indeed, the information hosted on clinicaltrials.gov attests to this trial being actively recruiting at present. This research was first made available April 24th 2017 and its latest update occurred June 15th 2022. The study is seeking 38 participants from a single site."

Answered by AI

Are there any prior experiments conducted with Fludarabine?

"Currently, Fludarabine is included in 708 active clinical trials with 113 Phase 3 studies. Although Philadelphia has the most sites researching this medication, there are over 12000 other locations conducting experiments on it."

Answered by AI

Is there an age limitation for recruitment into this trial?

"This clinical trial is applicable to adults ages 18-65. Nonetheless, there are 766 and 1966 studies dedicated to younger and older individuals respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

Damiano Rondelli, MD 2017. "Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03121014.

All > Mds > Myelodysplastic Syndrome