← Back to Search

Alkylating agents

Cord Blood Transplant + Chemo/Radiation for Leukemia and Lymphoma

Phase 2

Waitlist Available

Led By Ann E. Dahlberg

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Specific criteria for liver function, pulmonary function, and cardiac function

If 2 UCB units are required to reach the target cell dose, each unit must be a 4-6 antigen match to the recipient

Must not have

Patients who have received Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy are not eligible for Regimen A

Uncontrolled viral or bacterial infection at the time of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving an umbilical cord blood transplant together with chemotherapy and radiation therapy works better than just giving an umbilical cord blood transplant for treating patients with hematologic disease.

Who is the study for?

This trial is for patients with various hematologic diseases who have a specific match of human leukocyte antigens (HLA) with the umbilical cord blood donor. Adults must have a performance status score indicating they can carry out daily activities, and children must be able to perform most activities. Patients up to 65 years old may qualify depending on their disease, health conditions, and doctor's assessment. Pregnant or breastfeeding individuals, those with uncontrolled infections or HIV, or certain prior treatments are excluded.

What is being tested?

The study tests if chemotherapy drugs like cyclophosphamide and fludarabine combined with total-body irradiation (TBI), followed by an umbilical cord blood transplant can effectively treat hematologic diseases. It also looks at preventing immune reactions against the patient's body using medications such as cyclosporine and mycophenolate mofetil after the transplant.

What are the potential side effects?

Possible side effects include reactions from chemotherapy like nausea, hair loss, mouth sores; from TBI like fatigue and skin changes; risks associated with stem cell transplants such as infection risk increase due to low blood counts; graft-versus-host disease where donor cells attack your body; organ damage; infertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver, lungs, and heart are functioning well.

Select...

If I need 2 units of UCB, each must closely match my antigens.

Select...

I am between 6 months and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not received Y-90 ibritumomab or I-131 tostumomab as part of my treatment.

Select...

I do not have any uncontrolled infections.

Select...

I have a history of HIV infection.

Select...

I have not had a bone marrow transplant in the last 6 months.

Select...

I am 45 or older with a comorbidity score of 5 or more.

Select...

My large cell/high grade NHL did not respond to 2 or more treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Overall survival

Secondary study objectives

Change in level of chimerism at multiple time points

Incidence of chronic GVHD

Incidence of clinically significant infections

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (myeloablative UCBT)Experimental Treatment8 Interventions

Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.

Group II: Arm II (myeloablative UCBT)Experimental Treatment9 Interventions

Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Fludarabine

2012

Completed Phase 4

~1860