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Stem Cell Transplantation

Dilanubicel + Cord Blood Transplant for Leukemia and Myelodysplastic Syndromes

Phase 2
Recruiting
Led By Filippo Milano
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
Patients must meet specific renal, hepatic, pulmonary, and cardiac function criteria
Patients 10 to 65 years old with a hematologic malignancy in need of hematopoietic cell transplant who are > 30 kg and without a suitable related donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years post-transplant
Awards & highlights

Study Summary

This trial is studying how well dilanubicel, a cell product made from umbilical cord blood, works in treating patients with blood cancer.

Who is the study for?
This trial is for patients aged 18-65 with acute leukemia, chronic myeloid leukemia, or myelodysplastic syndromes who are eligible for a cord blood transplant. Participants must have good heart function and kidney health, no uncontrolled infections or recent severe fungal infections, not be HIV positive or pregnant, and haven't had a prior allogeneic transplant.Check my eligibility
What is being tested?
The study tests if a donor umbilical cord blood transplant combined with dilanubicel (expanded cord blood cells) after chemotherapy (fludarabine, cyclophosphamide) and radiation therapy can effectively treat blood cancers by replacing bone marrow stem cells and boosting the immune system to fight cancer.See study design
What are the potential side effects?
Potential side effects include reactions from the infusion of expanded cord blood cells, complications from chemotherapy such as nausea and hair loss, risks associated with total-body irradiation like fatigue and skin changes, plus typical transplantation risks like infection risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney, liver, lung, and heart functions meet the required health standards.
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I am between 10 and 65 years old, need a stem cell transplant for blood cancer, weigh more than 30 kg, and don't have a related donor.
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I am eligible for a cord blood transplant according to my hospital's rules.
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My condition is one of the following: acute leukemia, MDS, chronic myeloid leukemia, or I am receiving a specific intensity treatment regimen.
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I meet the age and health activity level requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of graft failure
Secondary outcome measures
Incidence and severity of acute graft versus host disease (GVHD)
Incidence and severity of chronic graft versus host disease (GVHD)
Incidence of adverse events
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, TBI, NLA101)Experimental Treatment13 Interventions
Patients receive either regimen A or regimen B. REGIMEN A: Patients (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo TBI BID on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0. REGIMEN B: Patients (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients undergo TBI QD on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0. All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo MUGA or ECHO, and CT during screening. Patients also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrocardiography
2014
N/A
~150
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1080
Total-Body Irradiation
1997
Completed Phase 3
~1180
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470
Thiotepa
2008
Completed Phase 3
~2210

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,315 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,458 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,695 Previous Clinical Trials
40,929,774 Total Patients Enrolled
1 Trials studying Biphenotypic Leukemia
44 Patients Enrolled for Biphenotypic Leukemia

Media Library

Umbilical Cord Blood Transplantation (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03399773 — Phase 2
Biphenotypic Leukemia Research Study Groups: Treatment (chemotherapy, TBI, NLA101)
Biphenotypic Leukemia Clinical Trial 2023: Umbilical Cord Blood Transplantation Highlights & Side Effects. Trial Name: NCT03399773 — Phase 2
Umbilical Cord Blood Transplantation (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03399773 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many precedents for Umbilical Cord Blood Transplantation?

"As of now, there are 937 studies in operation studying Umbilical Cord Blood Transplantation. 165 of those live trials are in Phase 3. While the majority of studies for Umbilical Cord Blood Transplantation are based in Philadelphia, Pennsylvania, there are 28788 locations running trials for this treatment."

Answered by AI

Are there risks associated with Umbilical Cord Blood Transplantation?

"While Phase 2 trials offer some evidence of safety, there is no data supporting efficacy. Consequently, our team at Power gave Umbilical Cord Blood Transplantation a score of 2."

Answered by AI

Who qualifies to participate in this research?

"This clinical trial is looking for 15 participants who currently have myelodysplastic syndrome with excess blasts. The ideal candidate will also meet the following criteria: Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% in a representative bone marrow aspirate, Patient must have hematologic malignancy that meets institutional eligibility requirements for cord"

Answered by AI

Are new patients being enrolled in this study?

"Yes, this trial is still looking for volunteers. The most recent update on clinicaltrials.gov was on May 11th, 2022 and the posting date was May 10th, 2022."

Answered by AI

Does this research require participants to be a certain age?

"This clinical trial only enrolls patients aged 18-65. There are 1179 other trials for minors and 2984 for senior citizens."

Answered by AI

How many people are eligible for this clinical trial?

"That is accurate. The website clinicaltrials.gov has the most recent information on this trial, which was first posted on May 10th, 2022 and last updated on May 11th, 2022. They are searching for 15 patients who meet the criteria to participate at 1 location."

Answered by AI

What conditions does Umbilical Cord Blood Transplantation typically help alleviate?

"Umbilical Cord Blood Transplantation is a standard treatment for multiple sclerosis. Additionally, it can be used to target other conditions like leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
2022. "Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03399773.
~3 spots leftby Oct 2024
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