Cyclosporine for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fred Hutch/University of Washington Cancer Consortium, Seattle, WAAcute Myeloid Leukemia+11 MoreCyclosporine - Drug
Eligibility
18 - 75
All Sexes
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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 Myeloid Leukemia (AML) arising from Myelodysplastic Syndrome (MDS)
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia (ALL)
  • Recurrent Mixed Phenotype Acute Leukemia
  • Refractory Acute Myelogenous Leukemia
  • Mixed Phenotype Acute Leukemia
  • Acute Recurrent Myeloid Leukemia
  • Refractory Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome With Excess Blasts (MDS-EB)

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 2 years

Up to 100 days
Disease-free survival
Overall survival
Day 100
Proportion of patients who develop grades III/IV Bearman regimen-related toxicity
Up to 2 years
Achievement of remission
Duration of remission
Non-relapse mortality
Up to day 100
Rates of engraftment
Up to day 180
Rates of acute graft versus host disease
Up to day 84
Rates of chimerism

Trial Safety

Trial Design

1 Treatment Group

Treatment (211^At-BC8-B10, PBSC)
1 of 1

Experimental Treatment

75 Total Participants · 1 Treatment Group

Primary Treatment: Cyclosporine · No Placebo Group · Phase 1 & 2

Treatment (211^At-BC8-B10, PBSC)Experimental Group · 9 Interventions: Fludarabine Phosphate, Cyclosporine, Laboratory Biomarker Analysis, Pharmacological Study, Peripheral Blood Stem Cell Transplantation, Mycophenolate Mofetil, Pretargeted Radioimmunotherapy, Sirolimus, Total-Body Irradiation · Intervention Types: Drug, Drug, Other, Other, Procedure, Drug, Radiation, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclosporine
FDA approved
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1360
Mycophenolate mofetil
FDA approved
Pretargeted Radioimmunotherapy
2010
Completed Phase 1
~20
Sirolimus
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,106 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
532 Previous Clinical Trials
1,315,186 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,154 Previous Clinical Trials
41,163,445 Total Patients Enrolled
Brenda M. SandmaierPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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.