Trials Sponsors Conditions Drugs Pricing

Conditions

Allogeneic Stem Cell Transplant Recipient Blasts 10 Percent or More of Bone Marrow Nucleated Cells Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia

Keywords

Recurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaMyelodysplastic Syndrome

Outcome Measures

Primary Outcomes (2)

Maximum tolerated dose (MTD) of membrane-bound interleukin-21-expanded haploidentical natural killer (NK) cells
The MTD will be defined as the highest safely tolerated dose where at most one patient in six experiences dose-limiting toxicity (DLT) during DLT observation period. DLT is defined as any steroid refractory acute graft versus host disease.
Up to 63 days
Incidence of adverse events
Toxicities will be assessed by type and grade using Common Terminology Criteria for Adverse Events version 5.0 and displayed in summary form by cohort and overall. Toxicities will be summarized and reported regardless of attribution and also only those attributed to NK cells.
Up to day 28

Secondary Outcomes (8)

Study Arms (2)

Conditioning Regimen

EXPERIMENTAL

Fludarabine 30 mg/m2/day (day -6 to day -2) and Cytarabine 2g/ m2/day (days -6 to day -2)

Drug: Cytarabine HydrochlorideDrug: Fludarabine

Induction

EXPERIMENTAL

Six doses of third-party-donor mbIL-21 expanded (KDS-1001) cells given thrice weekly for two weeks. Days may vary and KDS-1001 can be given from days 0 to 21

Biological: Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells

Interventions

Cytarabine HydrochlorideDrug

Given IV

Also known as: Ara-C HCl, Arabinosylcytosine Hydrochloride, Aracytidine Hydrochloride, CHX-3311, Cytosar Hydrochloride, Cytosine Arabinosine Hydrochloride, U-19920A

Conditioning Regimen

FludarabineDrug

Given IV

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Primary Relapsed AML including
Relapsed AML after allogeneic stem cells

Sponsors & Collaborators

Sumithira Vasu
Otherlead
Kiadis Pharma
Industrycollaborator

Study Sites (2)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Oregon Health & Science University

Portland, Oregon, 24344, United States

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Cytarabinefludarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine Nucleosides

Study Officials

Sumithira Vasu, MBBS
Ohio State University Comprehensive Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

19 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

September 26, 2019

First Posted

January 7, 2020

Study Start

June 11, 2020

Actual (reported)

Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Conditioning Regimen

Induction

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (3)

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Conditioning Regimen

Induction

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (3)

You may not qualify if:

Data Sharing

Source record

Documents

Locations