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Alkylating agents
Stem Cell Transplant for Infant Leukemia
Phase 2
Recruiting
Led By Christen Ebens, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High risk cytogenetics t(4;11) or other MLL rearrangements; chromosome 5, 7, or 19 abnormalities; complex karyotype (>5 distinct changes); ≥ 2 cycles to obtain complete response (CR); CR2 or higher; Preceding myelodysplastic syndrome (MDS); All patients must be in CR or early relapse (i.e., <15% blasts in BM).
Acute lymphocytic leukemia: high risk CR1 as evidenced by: High-risk cytogenetic: t(4;11) or other MLL rearrangements; hypodiploid; t(9;22); >1 cycle to obtain CR; CR2 or higher; All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1, 2, and 5 years after transplant
Awards & highlights
Study Summary
This trial is studying how well combination chemotherapy followed by a donor umbilical cord blood transplant works in treating infants with high-risk acute leukemia or myelodysplastic syndromes.
Who is the study for?
This trial is for infants under 3 years old with high-risk acute leukemia or myelodysplastic syndromes. They must be in complete remission or early relapse, have a matched donor for stem cell transplant, and good organ function. Infants can't join if they have an active infection, HIV, extramedullary disease, or had a myeloablative transplant within the last 6 months.Check my eligibility
What is being tested?
The study tests how well chemotherapy (busulfan, fludarabine, melphalan) followed by umbilical cord blood stem cell transplant works in treating infant leukemia. It also looks at preventing immune reactions against normal cells using cyclosporine and mycophenolate mofetil after the transplant.See study design
What are the potential side effects?
Possible side effects include reactions to chemotherapy like nausea and hair loss; complications from stem cell transplantation such as infections; and immune system's possible attack on the body's own cells despite preventive medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has high-risk features and is either in remission or early relapse.
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My leukemia is high risk, in remission, and my bone marrow shows less than 5% blasts.
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My liver tests are within 5 times the normal range.
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My kidney function is good, with a filtration rate over 60.
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My blood disorder is considered high risk but with less than 10% immature blood cells.
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My transplant match is almost perfect and the cell dose is high enough.
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I can do most activities and my organs work well.
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I have a sibling donor who is a complete match or a partially matched unrelated donor.
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My transplant match is perfect and the cell dose is high enough.
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My heart pumps well, with an ejection fraction over 45%.
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My treatment requires a specific match and cell dose.
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My acute myeloid leukemia is considered high risk.
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My cancer remains or is increasing despite having standard chemotherapy.
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I was diagnosed with a blood cancer before I turned 4 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 2 years after transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years after transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Engraftment
Secondary outcome measures
Developmental Outcomes
Disease-free survival
Incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade III-IV
+5 moreSide effects data
From 2013 Phase 2 & 3 trial • 7 Patients • NCT00775931100%
Acute Sinusitis
100%
Atelectasis
100%
Fungal Infection, Respiratory
100%
Pericardial Effusion
100%
Bacterial Infection, Respiratory
100%
Bacterial Infection, Feces
100%
Blood Clot in Bladder Wall
100%
Fungal Infection, Feces
100%
Requires Hemodialysis, NOS
100%
Hyperechogenic Renomegaly with Ascites
100%
Requires Intubation, NOS
100%
Large Splenic Infarct
100%
Low Lung Volumes
100%
Pneumonia
100%
Pulmonary Hemorrhage
100%
Small Bowel Ascites
100%
Viral Infection, Blood
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cord Blood Transplant Conditioning
Marrow Graft Transplant Conditioning
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single Unit UCB TransplantationExperimental Treatment7 Interventions
Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).
Group II: Double Unit UCB TransplantationExperimental Treatment7 Interventions
Patients that receive 2 units of umbilical cord blood transplantation (UCBT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cyclosporine
2000
Completed Phase 3
~1290
umbilical cord blood transplantation
2008
Completed Phase 3
~1120
mycophenolate mofetil
2000
Completed Phase 3
~1730
fludarabine phosphate
2000
Completed Phase 3
~2660
melphalan
1994
Completed Phase 3
~3530
filgrastim
1997
Completed Phase 3
~7260
busulfan
1999
Completed Phase 3
~3630
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,605 Total Patients Enrolled
Christen Ebens, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia has high-risk features and is either in remission or early relapse.My leukemia is high risk, in remission, and my bone marrow shows less than 5% blasts.My liver tests are within 5 times the normal range.My kidney function is good, with a filtration rate over 60.I have a history of HIV or tested positive for it.My blood disorder is considered high risk but with less than 10% immature blood cells.My transplant match is almost perfect and the cell dose is high enough.I can do most activities and my organs work well.I have a sibling donor who is a complete match or a partially matched unrelated donor.I do not have an active infection, including mold infections, at the time of transplantation.My transplant match is perfect and the cell dose is high enough.My heart pumps well, with an ejection fraction over 45%.I had a bone marrow transplant less than 6 months ago.My treatment requires a specific match and cell dose.My acute myeloid leukemia is considered high risk.My leukemia has spread outside the bone marrow.My cancer remains or is increasing despite having standard chemotherapy.I was diagnosed with a blood cancer before I turned 4 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Double Unit UCB Transplantation
- Group 2: Single Unit UCB Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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