Fludarabine + Total Marrow Irradiation for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndrome+3 MoreFludarabine + Total Marrow Irradiation - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to give radiation and chemotherapy before a stem cell transplant to people with leukemia or myelodysplasia.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Leukemia

Treatment Effectiveness

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: 3 years

1 year
Incidence of non-relapse mortality
Overall survival (OS) rate 1 year post transplant-Phase II only
100 days
Frequency of non hematologic toxicity
Incidence of acute graft versus host disease
Incidence of chronic graft versus host disease
Incidence of mucositis
Incidence of pneumonitis
Incidence of relapse mortality
Incidence of sinusoidal obstruction syndrome
3 years
Disease free survival
Year 3
Mean Quality of Life (QOL) as measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) version 4
Year 3
Overall Survival
Day 40
Maximum tolerated dose of Total Marrow Irradiation (TMI) followed by 150 mg/m2 fludarabine- Phase I only
rom date of transplant to the first of three consecutive days after transplantation during which the absolute neutrophil count (ANC) is greater than or equal to 0.5 x 10^9/liter
Time to engraftment of neutrophils
Day 0
Time to engraftment of platelets

Trial Safety

Trial Design

1 Treatment Group

Fludarabine + Total Marrow Irradiation
1 of 1

Experimental Treatment

53 Total Participants · 1 Treatment Group

Primary Treatment: Fludarabine + Total Marrow Irradiation · No Placebo Group · Phase 1 & 2

Fludarabine + Total Marrow Irradiation
CombinationProduct
Experimental Group · 1 Intervention: Fludarabine + Total Marrow Irradiation · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Naoyuki G. Saito, M.D., Ph.D.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Naoyuki Saito, MD PhDPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
57 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Duration of first CR < 6 months (if previously in CR), based on the best overall clinical assessment of the disease course, not solely based on blood test or bone marrow biopsy results.
Bone marrow blasts >25% within 30 days before the start of the conditioning regimen.
You have 10-19% blasts in peripheral blood white cells or bone marrow.
Basophils must be present in peripheral blood.