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Alkylating agents

Cord Blood Transplant for Leukemia

N/A
Recruiting
Led By Claudio Brunstein, 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
Patients who have achieved certain levels of remission or response to initial therapy
Patients within a certain age range (0 to 55 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2 years
Awards & highlights

Study Summary

This trial is testing a new way to treat leukemia with an unrelated umbilical cord blood transplant. The transplant will use a myeloablative preparative regimen, which will include the drugs cyclophosphamide, fludarabine, and fractionated total body irradiation.

Who is the study for?
This trial is for people aged 0-55 with certain blood diseases like leukemia, lymphoma, and myeloma. They should be in specific stages of the disease and have responded to initial treatments. Participants must consent to join. It's not for those who've had recent transplants, are pregnant or breastfeeding, HIV positive, or have had extensive prior therapy.Check my eligibility
What is being tested?
The study tests an umbilical cord blood transplant using a strong chemotherapy regimen (cyclophosphamide and fludarabine) plus total body irradiation as treatment for various hematological diseases. The goal is to see how well this combination works in patients with these conditions.See study design
What are the potential side effects?
Possible side effects include damage to bone marrow resulting in low blood cell counts, increased risk of infections, mouth sores from chemotherapy drugs Fludarabine and Cyclophosphamide; nausea; hair loss; liver problems due to Cyclosporine A; diarrhea from Mycophenylate mofetil.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My initial cancer treatment has been effective.
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I am between 0 and 55 years old.
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I have a specific type or stage of blood cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival at 1 year post-transplant
Secondary outcome measures
Incidence of acute graft versus host disease at 100 days.
Incidence of chronic graft versus host disease at 1 year.
Incidence of disease free survival
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Umbilical Cord Blood TransplantExperimental Treatment6 Interventions
The myeloablative preparative regimen will consist of cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI)followed by umbilical cord blood transplant. Immunosuppressive Cyclosporine and Mycophenylate Mofetil (MMF) will be administered pre- and post UCBT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Total Body Irradiation
2006
Completed Phase 3
~820
Cyclosporine
FDA approved
Mycophenylate mofetil
2005
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
270 Previous Clinical Trials
14,392 Total Patients Enrolled
Claudio Brunstein, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
252 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01962636 — N/A
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01962636 — N/A
Acute Myeloid Leukemia Research Study Groups: Umbilical Cord Blood Transplant
Acute Myeloid Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01962636 — N/A

Frequently Asked Questions

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

Are participants still being admitted to this research project?

"According to clinicaltrials.gov, the trial is open for enrollment at this moment in time. The study was initially posted on December 1st 2016 and most recently updated on November 2nd 2022."

Answered by AI

Are there any other published reports assessing the efficacy of Total Body Irradiation?

"Presently, 937 studies are underway exploring Total Body Irradiation. Of these active trials, 171 have reached Phase 3. Even though the majority of research for this procedure is centered in Philadelphia, Pennsylvania there exists 28877 other testing sites across the world."

Answered by AI

Are there any limits to the number of participants being recruited for this trial?

"Affirmative. The clinicaltrial.gov repository shows that the current status of this trial is actively recruiting, with an initial posting date on December 1st 2016 and most recent edit from November 2nd 2022. 200 participants are needed at a single site for completion of the study."

Answered by AI

In which cases is Total Body Irradiation commonly utilized?

"Total Body Irradiation is often used for transplantation and has also been deemed an effective treatment option for multiple sclerosis, lupus nephritis, as well as acute myelocytic leukemia."

Answered by AI
~13 spots leftby Oct 2024