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Anti-metabolites

Treosulfan-Based vs Clofarabine-Based Conditioning for Leukemia

Phase 2
Recruiting
Led By Phuong Vo
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DONOR: Human leukocyte antigen (HLA)-identical related donors or unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for only one HLA allele at class I is allowed
Diagnosis of MDS-EB or AML with less than 5% marrow blasts at time of transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after transplant
Awards & highlights

Study Summary

This trial looks at 2 different chemo regimens to see which is better before a stem cell transplant for blood cancers.

Who is the study for?
Adults aged 18-70 with myelodysplastic syndromes or acute myeloid leukemia, having less than 5% marrow blasts and a Karnofsky performance score of at least 60%. Participants must have compatible donors for stem cell transplant. Exclusions include severe non-cancer illnesses, active infections, HIV/hepatitis positivity, certain heart/lung/kidney diseases, pregnant or breastfeeding women, and those unwilling to use contraception.Check my eligibility
What is being tested?
The trial compares two pre-transplant chemotherapy regimens: treosulfan-based vs clofarabine-based conditioning. These treatments aim to eliminate cancer cells and make space in the bone marrow for donor stem cells which can regenerate healthy blood cells and help destroy any remaining cancer.See study design
What are the potential side effects?
Potential side effects may include damage to organs from chemotherapy drugs or total-body irradiation; risks associated with stem cell transplantation like infection risk due to immune suppression; reactions related to infusion of new stem cells; fatigue; nausea; liver complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My donor matches me closely in genetic markers for transplant.
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I have MDS-EB or AML with less than 5% marrow blasts.
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I can care for myself but cannot do normal activities or work.
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I am between 18 and 75 years old.
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I can donate stem cells and will use G-CSF for mobilization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after transplant 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
Secondary outcome measures
Duration of hospitalization
Incidence of acute graft versus host disease
Overall survival
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (clofarabine, TBI, HCT)Experimental Treatment3 Interventions
Patients receive clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI followed by HCT on day 0.
Group II: Arm A (treosulfan, fludarabine, TBI, HCT)Experimental Treatment4 Interventions
Patients receive treosulfan IV over 2 hours on days -6 to -4 and fludarabine IV over 30 minutes on days -6 to -2. Patients also undergo TBI followed by HCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Total-Body Irradiation
1997
Completed Phase 3
~1180
Treosulfan
2009
Completed Phase 3
~2320
Clofarabine
2007
Completed Phase 3
~1130
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,292 Total Patients Enrolled
Medexus Pharma, Inc.Industry Sponsor
3 Previous Clinical Trials
107 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,315 Total Patients Enrolled

Media Library

Clofarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04994808 — Phase 2
Myelodysplastic Syndrome Research Study Groups: Arm B (clofarabine, TBI, HCT), Arm A (treosulfan, fludarabine, TBI, HCT)
Myelodysplastic Syndrome Clinical Trial 2023: Clofarabine Highlights & Side Effects. Trial Name: NCT04994808 — Phase 2
Clofarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04994808 — Phase 2

Frequently Asked Questions

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

How hazardous is Hematopoietic Cell Transplantation for those receiving it?

"Preceding clinical trials have provided evidence of Hematopoietic Cell Transplantation's safety, so it attained a score of 2."

Answered by AI

Have there been investigations into Hematopoietic Cell Transplantation prior to this one?

"Presently, there are 385 active clinical trials related to Hematopoietic Cell Transplantation with 26 of those in the third phase. While most of these studies are located in Boston, Massachusetts, a total of 4352 medical sites throughout America are conducting such research."

Answered by AI

What criteria must participants meet to be able to join this research?

"This clinical trial is seeking 80 individuals between 18 and 70 years old who have been diagnosed with muscular dystrophy. Applicants must satisfy additional conditions, such as having an intermediate to very high Revised International Prognostic Scoring System (IPSS-R) score, exhibiting less than 5% marrow blasts via morphology or flow cytometry, possessing a Karnofsky performance score of at least 60%, being able to donate peripheral blood stem cells through granulocyte colony-stimulating factor mobilization if applicable, and potentially undergoing prior autologous or allogeneic hematopoietic stem cell transplantation."

Answered by AI

Is this research endeavor recruiting participants currently?

"Unfortunately, recruitment for this trial has ended. Its first post date was November 30th 2022 and the last update occurred on September 30th 2022. If you're interested in other medical studies, there are presently 2804 clinical trials actively seeking participants with muscular dystrophy and 385 studies recruiting patients for Hematopoietic Cell Transplantation therapy."

Answered by AI

What ailments can be addressed through Hematopoietic Cell Transplantation?

"Chronic lymphocytic leukemia is usually managed with Hematopoietic Cell Transplantation, which has also seen success in treating hsct conditioning therapy, refractory acute lymphoblastic leukemia (all), and acute myelocytic leukemia."

Answered by AI

How many participants are currently taking part in this medical experiment?

"At this moment in time, no candidates are being sought for the trial which went up on November 30th 2022 and was recently edited on September 30th. Should you search for other studies relating to muscular dystrophy, there are currently 2804 trials with openings; 385 open clinical trails associated with Hematopoietic Cell Transplantation also exist."

Answered by AI

Are persons aged 30 and older eligible to participate in this investigation?

"Eligibility for this medical trial necessitates that individuals are aged 18-70. For those who do not meet the age requirements, 947 studies exist catering to minors and 2415 trials have been developed with seniors in mind."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia
2023. "Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04994808.
~53 spots leftby Oct 2026
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