Experimental Infusion for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH
Myelodysplastic Syndromes+23 More
Fludarabine Phosphate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. The purpose of this study is to show that using two medicines (vactosertib and IL-2) with NK cells will be safe and will activate the donor NK cells. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.

Eligible Conditions

  • Myelodysplastic Syndromes
  • Colorectal Carcinoma (CRC)
  • Rectum Cancer
  • Chronic Lymphocytic Leukemia (CLL)
  • Myeloproliferative Syndromes
  • Malignancies, Hematologic
  • Leukemia Chronic Myelogenous Leukemia (CML)
  • Non-Hodgkin's Lymphoma (NHL)
  • Acute Lymphoblastic Leukemia (ALL)
  • Lymphoma, Hodgkins
  • Plasma Cell Myeloma
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 28 days post-treatment

28 days post-treatment
Clinical Response
Persistence of donor NK cells
Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Safety of NK feeder-expanded NK cells with IL-2 and vactosertib.

Trial Safety

Safety Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Trial Design

1 Treatment Group

Experimental Infusion
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Experimental Infusion · No Placebo Group · Phase 1

Experimental InfusionExperimental Group · 5 Interventions: Fludarabine Phosphate, Cyclophosphamide, Natural Killer Cells, Vactosertib, IL-2 · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Phosphate
1997
Completed Phase 3
~2560
Cyclophosphamide
1995
Completed Phase 3
~4020
IL-2
2007
Completed Phase 4
~1150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days post-treatment
Closest Location: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center · Cleveland, OH
Photo of Cleveland  1Photo of Cleveland  2Photo of Cleveland  3
2022First Recorded Clinical Trial
3 TrialsResearching Myelodysplastic Syndromes
18 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must have histologically confirmed locally advanced or metastatic colorectal adenocarcinoma or relapsed or refractory hematologic malignancy and have failed at least one standard line of chemotherapy.
You have a blood test that shows acute myeloid leukemia.
You have myelodysplastic syndrome.
Plasma cell myeloma is a cancer of the bone marrow and bone.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.