← Back to Search

Alkylating agents

Cord Blood Transplant + Chemo/Radiation for Leukemia and Lymphoma

Q: Is it possible to enroll in this research project at this time?

The trial is still recruiting patients, according to the most recent update on clinicaltrials.gov from September 8th, 2022. The posting for the trial was made 18 November, 2005.

Q: What is the current FDA stance on Umbilical Cord Blood Transplantation?

Although there is some data suggesting it is safe, Umbilical Cord Blood Transplantation only received a score of 2 because there is no evidence that it actually works.

Q: What are some conditions that Umbilical Cord Blood Transplantation can help treat?

While transplantation is most often treated with Umbilical Cord Blood Transplantation, this method can also be effective for managing other conditions such as <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, <a href="https://www.withpower.com/clinical-trials/lupus">lupus</a> nephritis, and <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic, acute.

Q: Does this experimental treatment only cater to a certain age demographic?

As long as they are between 6 months and 45 years old, patients meet the age requirements for this clinical trial.

Q: Could you please provide a list of other research projects that have looked into Umbilical Cord Blood Transplantation?

Currently, there are 1041 active clinical trials studying umbilical cord blood transplantation. Of these trials, 185 are in phase 3. The majority of the trials for umbilical cord blood transplantation are located in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>; however, there are 29821 locations running studies for umbilical cord blood transplantation globally.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival

Secondary outcome measures

Change in level of chimerism at multiple time points

Incidence of chronic GVHD

Incidence of clinically significant infections

+8 more

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

Fludarabine

2012

Completed Phase 3

~1100

Umbilical Cord Blood Transplantation

2009

Completed Phase 2

~470

Thiotepa

2008

Completed Phase 3

~2150

Cyclophosphamide

1995

Completed Phase 3

~3780

Total-Body Irradiation

1997

Completed Phase 3

~1180

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Cyclosporine

1997

Completed Phase 3

~1830

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,110 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,133 Total Patients Enrolled

Ann E. DahlbergPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00719888 — Phase 2

Chronic Myelogenous Leukemia Research Study Groups: Treatment (myeloablative UCBT), Arm II (myeloablative UCBT)

Chronic Myelogenous Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00719888 — Phase 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00719888 — Phase 2

Frequently Asked Questions

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

What is the maximum number of patients who can be enrolled in this research project?

"According to the information available on clinicaltrials.gov, this research project is still recruiting patients. The first announcement was made on November 18th, 2005 and the most recent update happened September 8th of this year. They are looking for 135 individuals total across 1 location."

Answered by AI

Who would the investigators consider to be an eligible study participant?

"This study aims to recruit 135 patients with refractory anemia between the ages of 6 months and 45. The most important criteria for eligibility are as follows: high-dose TBI regimen: 6 months to =< 45 years, If 2 UCB units are required to reach the target cell dose, each unit must be a 4-6 antigen match to the recipient, Middle-intensity TBI regimen: 6 months to =< 65 years, Conditioning regimen selection should be based on the underlying disease, presence of minimum residual disease (MRD), age, co-morbidities, and attending physician's recommendation. Very"

Answered by AI

Is it possible to enroll in this research project at this time?

"The trial is still recruiting patients, according to the most recent update on clinicaltrials.gov from September 8th, 2022. The posting for the trial was made 18 November, 2005."

Answered by AI

What is the current FDA stance on Umbilical Cord Blood Transplantation?

"Although there is some data suggesting it is safe, Umbilical Cord Blood Transplantation only received a score of 2 because there is no evidence that it actually works."

Answered by AI

What are some conditions that Umbilical Cord Blood Transplantation can help treat?

"While transplantation is most often treated with Umbilical Cord Blood Transplantation, this method can also be effective for managing other conditions such as multiple sclerosis, lupus nephritis, and leukemia, myelocytic, acute."

Answered by AI

Does this experimental treatment only cater to a certain age demographic?

"As long as they are between 6 months and 45 years old, patients meet the age requirements for this clinical trial."

Answered by AI

Could you please provide a list of other research projects that have looked into Umbilical Cord Blood Transplantation?

"Currently, there are 1041 active clinical trials studying umbilical cord blood transplantation. Of these trials, 185 are in phase 3. The majority of the trials for umbilical cord blood transplantation are located in Philadelphia, Pennsylvania; however, there are 29821 locations running studies for umbilical cord blood transplantation globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

2005. "Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00719888.

All > Childhood Leukemia > Restasis