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Stem Cell Transplant + Chemo for Blood Cancer
Phase 2
Recruiting
Led By Mark Juckett
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 months
Awards & highlights
Study Summary
This trial studies a low-toxicity transplant for blood cancer. It includes chemo, radiation, stem cell infusion, and drugs to prevent GVHD.
Who is the study for?
This trial is for people aged 0-75 with various blood diseases or leukemias in remission, who have a compatible donor for stem cell transplant. They must not be pregnant, breastfeeding, or have untreated infections and should have adequate heart, lung, liver, and kidney function. HIV+ individuals can join if they're on treatment with an undetectable viral load.Check my eligibility
What is being tested?
The study tests a non-myeloablative preparative regimen using cyclophosphamide/fludarabine/total body irradiation followed by stem cell infusion from related/unrelated donors. Post-transplant care includes cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil to prevent graft-versus-host disease.See study design
What are the potential side effects?
Possible side effects include reactions to medication infusions; organ damage due to the drugs or radiation; increased risk of infections; graft-versus-host disease where the new cells attack the body; and complications from suppressed bone marrow function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate rates of acute graft-versus-host disease (GVHD)
Evaluate rates of chronic graft-versus-host disease (GVHD)
Secondary outcome measures
Observe rates of relapse (RR)
Observe transplant related mortality (TRM)
Overall Survival (OS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cy/Flu/TBI + Post transplant CYExperimental Treatment8 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Peripheral Blood Stem Cell Transplant
2011
Completed Phase 2
~80
Allopurinol 300 MG
2019
Completed Phase 3
~700
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Total Body Irradiation
2006
Completed Phase 3
~820
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Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,597 Total Patients Enrolled
Mark JuckettPrincipal InvestigatorUniversity of Minnesota Masonic Cancer Center
2 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 0 and 75 years old and mostly able to care for myself.I have a diagnosis of leukemia, lymphoma, or a related blood disorder.My donor is a close genetic match to me.I had a bone marrow transplant less than 3 months ago.I currently have an infection that hasn't been treated.I have an active brain or spinal cord tumor.My leukemia is in a very advanced stage.My condition meets the specific requirements for bulky disease.My related donor will follow the UMN BMT program's standard procedures.My liver, kidneys, heart, and lungs are functioning well.My lymphoma is worsening despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cy/Flu/TBI + Post transplant CY
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.
Is there potential for harm from the combined Cy/Flu/TBI + Post transplant CY treatment?
"With limited data available on efficacy, the safety of Cy/Flu/TBI + Post transplant CY was ranked a 2. This score takes into account that there is some prior evidence which suggests its safety profile."
Answered by AI
Is enrollment still open for participation in this trial?
"As per information on clinicaltrials.gov, this research is not currently recruiting participants. The trial was first posted in April 1st 2023 and last updated on March 27th 2023. Nonetheless, there are over 4400 other medical protocols that have active recruitment needs at present."
Answered by AI
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