CIML NK for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MAAcute Myeloid Leukemia+3 MoreCIML NK - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying CIML NK cells plus IL-2 in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms who have relapsed after stem cell transplantation.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myeloproliferative Neoplasms
  • Myelodysplastic Syndrome
  • Juvenile Myelomonocytic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 1 Year

1 Year
Chronic GVHD requiring immune suppressants (IS)
Leukemia free survival (LFS)
Overall survival (OS)
chronic GVHD
100 Days, 1 Year
LFS and OS
PFS and OS
100 Days, 6 Months
acute GVHD
180 Days
Grade I-IV acute GVHD
28 Days
Best Overall Response (CR, CRi)
28 days
ORR
6 Weeks
CTCAE grade 3 or higher immune reactions
Safety (DLT by 6 weeks)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

CIML NK
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: CIML NK · No Placebo Group · Phase 1

CIML NKExperimental Group · 3 Interventions: Fludarabine, CIML NK, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

The Leukemia and Lymphoma SocietyOTHER
75 Previous Clinical Trials
16,780 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,026 Previous Clinical Trials
753,906 Total Patients Enrolled
Rizwan RomeeLead Sponsor
Rizwan Romee, MDPrincipal InvestigatorDana-Farber Cancer Institute
Roman M. Shapiro, MDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age Any Age · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

What is the scope of patients participating in this clinical trial?

"Affirmative. Per the details published on clinicaltrials.gov, this research project is actively recruiting participants and was last updated on June 15th 2022. 50 individuals shall be sourced from two sites for inclusion in the study; it first opened to applicants back on August 31st 2019." - Anonymous Online Contributor

Unverified Answer

What have been the major findings of research concerning CIML NK?

"At present, 889 live studies are being conducted on CIML NK. Out of these research operations, 161 have reached the advanced Phase 3 stage. While a majority of trials occur in Philadelphia, Pennsylvania - 28443 sites around the world are running experiments with this drug treatment." - Anonymous Online Contributor

Unverified Answer

What evidence exists to demonstrate the safety of CIML NK for patients?

"There is only a small amount of evidence attesting to the safety and efficacy of CIML NK, thus it received an assessment of 1." - Anonymous Online Contributor

Unverified Answer

What symptoms have been addressed most often with CIML NK therapy?

"CIML NK is a popular medication for the treatment of multiple sclerosis, but it may also be efficacious in treating conditions such as mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastoma." - Anonymous Online Contributor

Unverified Answer

Are there any available openings for participants in this research?

"Affirmative. Clinicaltrials.gov suggests that this research study is still searching for participants, which was first made known on August 31st 2019 and has been revised as of June 15th 2022. The trial necessitates 50 people to be enrolled from two separate medical sites." - 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.