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Anti-metabolites

Treosulfan and Fludarabine for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by medac GmbH

Eligibility Criteria Checklist

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

Must have

Participants must have available matched-related, matched-unrelated, haploidentical, or a mismatched unrelated donor with specific HLA matching criteria

Participants with AML or MDS who qualify for treosulfan-based conditioning treatment indicated for alloHSCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -4 and day -2: pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose

Awards & highlights

Study Summary

This trial aims to see if kidney function and race affect how the drug treosulfan works in the body. They want to find a safe dose for patients with kidney problems undergoing stem cell transplant for

Who is the study for?

Adults aged 18-80 with acute myeloid leukemia or myelodysplastic syndrome, eligible for stem cell transplant and treosulfan treatment. Must have a compatible donor, adequate kidney function (creatinine clearance >=30 mL/min), and agree to use effective birth control. Excludes pregnant women.Check my eligibility

What is being tested?

The study is testing how kidney function and race/ethnicity affect the body's handling of Treosulfan in patients receiving it as part of their conditioning regimen before stem cell transplantation for certain blood disorders.See study design

What are the potential side effects?

Potential side effects of Treosulfan may include nausea, vomiting, fatigue, lowered blood counts leading to increased infection risk, liver problems, and potential harm to kidneys or other organs.

Eligibility Criteria

Inclusion Criteria

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

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I have a donor who matches me closely for a transplant.

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I have AML or MDS and am eligible for a specific transplant prep treatment.

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My kidneys are functioning well enough (creatinine clearance >=30 mL/min).

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I am between 18 and 80 years old.

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I am mostly able to care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -4 and day -2: pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -4 and day -2: pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -4 and day -2: pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Concentration-time Curve From Time of Administration to Time of Infinity (AUCinf) for Treosulfan

Area Under the Concentration-time Curve From Time of Administration to the Last Measurable Concentration (AUClast) for Treosulfan

Secondary outcome measures

Area Under the Concentration-time Curve From Time of Administration to 24 hours (AUC0-24) for Treosulfan and its Metabolite Treosulfan Monoepoxide

Area Under the Concentration-time Curve From Time of Administration to the Last Measurable Concentration (AUClast) for Treosulfan Metabolite (Treosulfan Monoepoxide)

Area Under the Plasma Concentration-time Curve From Time of Administration to Time of Infinity (AUCinf) for Treosulfan Metabolite (Treosulfan Monoepoxide)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treosulfan and FludarabineExperimental Treatment2 Interventions

Participants will receive treosulfan 10 gram per square meter (g/m^2), intravenous (IV) infusion, given over 2 hours once daily on three consecutive days (day -4 to day -2), followed by fludarabine, 30 milligram per square meter (mg/m^2) IV infusion once daily on 5 consecutive days (days -6 to -2), preceding allogeneic haematopoietic stem cell transplantation (alloHSCT) on Day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Treosulfan

2009

Completed Phase 3

~2320

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Synteract, Inc.Industry Sponsor

20 Previous Clinical Trials

5,866 Total Patients Enrolled

medac GmbHLead Sponsor

38 Previous Clinical Trials

9,070 Total Patients Enrolled

Frequently Asked Questions

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

Does this medical study allow individuals who are at least 18 years old to participate?

"Potential candidates must be at least 18 years of age but no more than 80 years old to be considered for inclusion in this research."

Answered by AI

Are multiple facilities within the state conducting this medical investigation?

"Patients can enroll in this research at notable institutions such as Memorial Sloan Kettering Cancer Center in New york City, The Ohio State University in Columbus, Ohio, and VCU Massey Cancer Center in Richmond, Virginia. These are among the four sites participating in the trial."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Affirmative. The information on clinicaltrials.gov reveals that this investigation is currently seeking eligible individuals. Initially shared on February 1st, 2024, with the latest update made on February 19th, 2024, this trial aims to recruit a total of 36 volunteers from four distinct locations."

Answered by AI

Is the enrollment for this medical study currently open and accepting participants?

"Per the details on clinicaltrials.gov, this investigation is presently enrolling volunteers. The trial was initially listed on 2/1/2024 and last revised on 2/19/2024."

Answered by AI

What are the safety profiles of Treosulfan and Fludarabine for individuals undergoing treatment?

"According to our evaluation at Power, the safety rating for Treosulfan and Fludarabine is 1 on a scale of 3. This score reflects that as a Phase 1 trial, there is only preliminary data available regarding the safety and effectiveness of this combination therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

2024. "Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05534620.