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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 within a certain age range (0 to 55 years)
Be younger than 65 years old
Must not have
HIV positive patients
Patients with chemotherapy refractory large cell and high grade NHL (i.e. progressive disease after > 2 salvage regimens)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group

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.
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.
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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I am between 0 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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My large cell or high grade NHL cancer did not respond to more than 2 treatments.
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I've had extensive cancer treatment, including long-term alkylator therapy or radiation.
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I have had a bone marrow transplant within the last 6 months if I am under 18, or any type of bone marrow transplant if I am older than 18.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Survival at 1 year post-transplant
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Umbilical cord blood
2020
N/A
~70
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
279 Previous Clinical Trials
15,381 Total Patients Enrolled
8 Trials studying Burkitt Lymphoma
555 Patients Enrolled for Burkitt Lymphoma
Claudio Brunstein, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
252 Total Patients Enrolled
1 Trials studying Burkitt Lymphoma
2 Patients Enrolled for Burkitt Lymphoma

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
Burkitt Lymphoma Research Study Groups: Umbilical Cord Blood Transplant
Burkitt Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01962636 — N/A
~23 spots leftby Oct 2025
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