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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2 years

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