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Alkylating agents
Stem Cell Transplantation for Blood Cancers
Phase 2
Recruiting
Led By Margaret MacMillan
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 months
Awards & highlights
Study Summary
This trial tests a new stem cell transplantation method for treating blood cancer in children & adults.
Who is the study for?
This trial is for children and adults up to 60 years old with various blood cancers, including leukemia and myelodysplasia. Participants must have confirmed hematological malignancies, be in a specific health condition (Karnofsky performance status ≥ 70% or Lansky play score ≥ 50%), and have adequate organ function. Pregnant individuals, those with active infections or known HIV/Hepatitis B/C, prior transplants, CML blast crisis, or CNS malignancy cannot join.Check my eligibility
What is being tested?
The study tests T cell receptor alpha/beta depletion PBSC transplantation using drugs like Fludarabine, Busulfan, Melphalan, Rituximab & Levetiracetam on patients with blood cancers. It's an open-label phase II trial aiming to see how well this treatment works for these conditions.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to stem cell transplant process; chemotherapy-related nausea; fatigue; risk of infection; possible liver damage from drugs like Busulfan; neurological issues from Levetiracetam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 85 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the rate of GVHD after alpha beta TCR depletion
Secondary outcome measures
Graft Failure
Non-relapse mortality (NRM)
Overall survival (OS)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI RegimenExperimental Treatment2 Interventions
Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Group II: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients OnlyExperimental Treatment5 Interventions
Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.
Group III: Fludarabine (flu), Busulfan (bu), Flu/Bu RegimenExperimental Treatment4 Interventions
Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Busulfan
2008
Completed Phase 3
~1120
Melphalan
2008
Completed Phase 3
~1500
Rituximab
1999
Completed Phase 4
~1880
Levetiracetam
2017
Completed Phase 4
~3990
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,503 Total Patients Enrolled
Margaret MacMillanPrincipal InvestigatorUniversity of Minnesota Masonic Cancer Center
Najla El JurdiPrincipal InvestigatorUniversity of Minnesota Masonic Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active brain or spinal cord tumor.I am 60 years old or younger.My leukemia is considered low risk based on specific criteria.I have been diagnosed with Acute Myeloid Leukemia or a related condition.My condition is in the blast phase of chronic myeloid leukemia.My blood cancer has been confirmed by lab tests.I have had a stem cell transplant before.My organs are working well.I can care for myself but may not be able to do active work or play.I have been diagnosed with acute leukemia.I do not have an active infection.
Research Study Groups:
This trial has the following groups:- Group 1: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen
- Group 2: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
- Group 3: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
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.
How many participants are being enrolled in this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this research is actively searching for suitable candidates and has a current enrollment of 150 patients from one medical centre. The trial was first posted on May 11th 2023 and its details have been recently updated as of 12th May 2023."
Answered by AI
Are participants currently being enrolled in this research endeavor?
"Affirmative. According to the information on clinicaltrials.gov, this medical trial is currently sourcing applicants and was first published on May 11th 2023 with its most recent update occurring one day later. There are 150 slots available at a single hospital centre."
Answered by AI
What health risks have been associated with the Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen when used in pediatric patients?
"Our team at Power assigned Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only a score of 2 to indicate that, although there exists some evidence supporting safety, no data has been collected in regards to its efficacy."
Answered by AI
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