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Procedure

Total-Body Irradiation for Minimal Residual Disease

Phase 2
Waitlist Available
Led By H. Joachim Deeg
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 year
Awards & highlights

Study Summary

This trial is testing treosulfan and fludarabine phosphate with or without total-body irradiation before a donor stem cell transplant for myelodysplastic syndrome or acute myeloid leukemia.

Eligible Conditions
  • Minimal Residual Disease
  • Myelodysplastic Syndrome
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Number of Participants That Did Not Progress Within 6 Months
Secondary outcome measures
Change in Gene Expression Profiles
Incidence of Chronic GVHD Graded by the NCI CTCAE Version 4.0
Incidence of Relapse/Progression
+4 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478
23%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment5 Interventions
Arm B: Treosulfan, Fludarabine Phosphate, TBI Treosulfan and fludarabine phosphate as in Arm A and undergo low -dose total-body irradiation (TBI) on day 0
Group II: Arm AExperimental Treatment6 Interventions
Arm A: Treosulfan, Fludarabine Phosphate Treosulfan intravenously (IV) over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Bone Marrow Transplantation
2009
Completed Phase 2
~470
Fludarabine
FDA approved
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Total-Body Irradiation
1997
Completed Phase 3
~1180
Treosulfan
FDA approved

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,143 Total Patients Enrolled
1 Trials studying Minimal Residual Disease
24 Patients Enrolled for Minimal Residual Disease
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,114 Total Patients Enrolled
1 Trials studying Minimal Residual Disease
24 Patients Enrolled for Minimal Residual Disease
National Cancer Institute (NCI)NIH
13,646 Previous Clinical Trials
40,930,925 Total Patients Enrolled
10 Trials studying Minimal Residual Disease
197 Patients Enrolled for Minimal Residual Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Joachim Deeg 2013. "Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01894477.
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