Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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, and 2 years after cbt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1, and 2 years after cbt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Cumulative incidence of neutrophil and platelet engraftment
Incidence of adverse events
Incidence of chronic graft-versus-host disease (cGVHD)
+9 moreTrial 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
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Total-Body Irradiation
1997
Completed Phase 3
~1180
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470
Cyclosporine
1997
Completed Phase 3
~1830
Cyclophosphamide
1995
Completed Phase 3
~3770
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Thiotepa
2008
Completed Phase 3
~2210
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,341 Total Patients Enrolled
National Cord Blood NetworkUNKNOWN
Ann DahlbergPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
7 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the eligibility to participate in this clinical study?
"This clinical trial seeks 54 individuals with acute leukemia aged between 6 Months and 65."
Answered by AI
Does the trial offer participation to individuals below two decades of age?
"The age range for participants in this trial is 6 months to 65 years old. Specifically, 825 trials are available for individuals younger than 18 and 3809 studies exist that accept patients over the age of 65."
Answered by AI
Has the FDA sanctioned Arm I (myeloablative UCBT) for use?
"Our team at Power estimates the safety of Arm I (myeloablative UCBT) to be a 2 due to prior Phase 2 trial data which suggests some security but no proof of efficacy."
Answered by AI
Is this medical experiment presently enrolling participants?
"The clinical trial described, which was originally posted on January 1st 2024 and last modified on August 22nd 2023, is no longer recruiting patients. However, the same website reveals there are over 4300 other trials that currently require volunteers."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger