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Radioimmunotherapy

Peripheral Blood Stem Cell Transplantation for Acute Leukemia

Phase 1 & 2
Waitlist Available
Led By Brenda M. Sandmaier
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
AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)
AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial gives cancer patients astatine-211, a radioactive substance, before their donor stem cell transplant. The hope is that the astatine will kill the cancer cells while having less of an effect on the healthy cells.

Eligible Conditions
  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Acute Myelogenous Leukemia

Eligibility Criteria

Inclusion Criteria

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

Timeline

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
Proportion of patients who develop grades III/IV Bearman regimen-related toxicity
Secondary outcome measures
Achievement of remission
Disease-free survival
Duration of remission
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (211^At-BC8-B10, PBSC)Experimental Treatment8 Interventions
Patients receive 211^At-BC8-B10 IV over 6-8 hours on day -7 and fludarabine phosphate IV over 30 minutes on days -4, -3 and -2. Patients undergo TBI and PBSC transplant on day 0. Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 and then tapered to day 180, or continuing to day 96 and then tapered to day 150. Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on day 0 and then reduced to every 12 hours on days 30-150 then tapered to day 180 (for patients with unrelated donors).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Total-Body Irradiation
1997
Completed Phase 3
~1180
Pretargeted Radioimmunotherapy
2010
Completed Phase 1
~20
Cyclosporine
1997
Completed Phase 3
~1830
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,306 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
555 Previous Clinical Trials
1,334,651 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,571 Total Patients Enrolled

Frequently Asked Questions

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

Are there any other scientific papers which have researched Cyclosporine?

"At this time, 599 clinical trials are underway that focus on cyclosporine. Of these, 58 are in phase 3. Many of the trials for cyclosporine are based in Philadelphia, Pennsylvania; however, there are 5940 locations running studies for this treatment across the globe."

Answered by AI

Is this research project only testing people who are under 40 years old?

"The age requirements to participate in this study are between 18-75 years old."

Answered by AI

How can I enroll in this research project?

"Eligibility requirements for this leukemia clinical trial include being between 18 and 75 years old. Myelomonocytic and chronic subtypes of the cancer are also admissible. A total of 50 patients are needed for recruitment."

Answered by AI

Are investigators still looking for study participants?

"This study, which was originally posted on October 24th 2017, is still actively recruiting participants according to information found on clinicaltrials.gov. The listing was last updated on August 29th 2022."

Answered by AI

How is Cyclosporine most often used to help patients?

"Cyclosporine is often used to treat lymphoma, non-hodgkin. Other potential benefits of taking cyclosporine include prevention of stem cell transplant rejection, interstitial cystitis treatment, and managing nephrotic syndrome."

Answered by AI
~10 spots leftby Mar 2025