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Total Body Irradiation for Chronic Lymphocytic Leukemia

University of Minnesota Masonic Cancer Center, Minneapolis, MN
Chronic Lymphocytic Leukemia+17 More ConditionsTotal Body Irradiation - Radiation
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Leukemia
  • Chronic Lymphocytic Leukemia
  • Leukemia, Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Myelodysplasia
  • Myelofibrosis
  • Lymphoplasmacytic Lymphoma
  • Prolymphocytic Leukaemia
  • Lymphoblastic Lymphoma
  • Burkitt Lymphoma
  • Marginal Zone B-Cell Lymphoma
  • Follicular Lymphoma
  • Multiple Myeloma
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Total Marrow Irradiation
1
TregGraft (Orca-T)
1
Allogeneic HSCT

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 1, 2 years

1 year
Incidence of chronic graft versus host disease at 1 year.
Pattern of chimerism after transplant.
Platelet engraftment at 1 year.
Survival at 1 year post-transplant
1, 2 years
Incidence of disease free survival
Incidence of overall survival.
100 days
Incidence of acute graft versus host disease at 100 days.
Incidence of graft failure.
42 days
Incidence of neutrophil engraftment at day 42.
6 months
Incidence of transplant related mortality at 6 months.

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Total Marrow Irradiation
1
TregGraft (Orca-T)
1
Allogeneic HSCT

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
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.

Trial Design

1 Treatment Group

Umbilical Cord Blood Transplant
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Total Body Irradiation · No Placebo Group · N/A

Umbilical Cord Blood TransplantExperimental Group · 6 Interventions: Fludarabine, Cyclophosphamide, Total Body Irradiation, Cyclosporine A, Umbilical cord blood, Mycophenylate mofetil · Intervention Types: Drug, Drug, Radiation, Drug, Biological, Drug
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
~890
Cyclosporine
FDA approved
Mycophenylate mofetil
2005
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 2 years

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
265 Previous Clinical Trials
15,822 Total Patients Enrolled
Claudio Brunstein, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
252 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between the ages of 0 and 55.
You have an advanced stage of myelofibrosis.
You have had at least two previous treatments, and your cancer went away for more than a year before coming back.
If you have a large lymph node mass (more than 5 cm), you may need chemotherapy to shrink it before the transplant.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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