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Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant

NCT00796068 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-02-17

Study results available
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Summary

This phase II trial studies how well giving treosulfan together with fludarabine phosphate and total-body irradiation (TBI) works in treating patients with hematological cancer who are undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CsA) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.

Conditions

  • Acute Biphenotypic Leukemia
  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Blasts Under 5 Percent of Bone Marrow Nucleated Cells
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Myelodysplastic Syndrome (MDS)

Interventions

DRUG

Cyclosporine

Given IV or PO

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given IV

RADIATION

Total-Body Irradiation

TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)

DRUG

Treosulfan

Given IV

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo single or double unit UCBT

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Filippo Milano · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-24
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796068 on ClinicalTrials.gov