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Chemotherapy
Cord Blood Transplant + Chemo for Blood Cancers
Phase 2
Recruiting
Led By Ann Dahlberg
Research Sponsored by Fred Hutchinson Cancer 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 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well giving cord blood transplant and chemo helps treat hematologic diseases.
Who is the study for?
This trial is for patients aged 6 months to 65 years with high-risk blood cancers like leukemia, who haven't responded well to initial treatments or have specific genetic abnormalities. They must be in remission but can have some remaining cancer signs. Good organ function and performance status are required, and they shouldn't be pregnant, breastfeeding, or have had certain other recent treatments.
What is being tested?
The study tests if a cord blood transplant (CBT) combined with chemotherapy drugs cyclophosphamide, fludarabine, thiotepa and total-body irradiation (TBI) is effective for high-risk hematologic diseases. It aims to destroy cancer cells and prevent immune rejection of the donor stem cells which help rebuild the patient's bone marrow.
What are the potential side effects?
Possible side effects include reactions from the body's immune response against normal cells post-transplant, infection risks due to weakened immunity from chemotherapy and TBI, organ inflammation from medications used after transplant like cyclosporine and mycophenolate mofetil.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1, 2 and 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1, 2 and 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival
Secondary study objectives
Cumulative incidence of neutrophil and platelet engraftment
Incidence of adverse events
Incidence of chronic graft-versus-host disease (cGVHD)
+7 moreAwards & Highlights
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 II (myeloablative UCBT)Experimental Treatment13 Interventions
See detailed description.
Group II: Arm I (myeloablative UCBT)Experimental Treatment12 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470
Cyclophosphamide
2010
Completed Phase 4
~2310
Thiotepa
2008
Completed Phase 3
~2120
Cyclosporine
1997
Completed Phase 3
~1820
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Total-Body Irradiation
1997
Completed Phase 3
~1180
Biospecimen Collection
2004
Completed Phase 3
~2030
Echocardiography
2013
Completed Phase 4
~11580
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
571 Previous Clinical Trials
1,340,917 Total Patients Enrolled
National Cord Blood NetworkUNKNOWN
Ann DahlbergPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
7 Total Patients Enrolled