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Procedure

Total-Body Irradiation for Myelodysplastic Syndrome

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 at 6 months post-transplant

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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

Cancer
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic/myeloproliferative neoplasm
Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants That Did Not Progress Within 6 Months

Secondary study objectives

Change in Gene Expression Profiles

Relapse Risk as Measured by Degree of Change in Gene Expression Profiles

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~530

Fludarabine

FDA approved

Peripheral Blood Stem Cell Transplantation

1997