NCT02493829

Brief Summary

The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2017

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

June 9, 2015

Last Update Submit

April 12, 2017

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

  • Vaccine-related toxicity based on the NCI criteria V4.0

    52 weeks

  • Frequency, severity of adverse events to the AML cell vaccine

    52 weeks

Study Arms (1)

AML Cell Vaccine

EXPERIMENTAL
Biological: AML Cell Vaccine

Interventions

AML Cell VaccineBIOLOGICAL
AML Cell Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
  • Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).

You may not qualify if:

  • Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12\~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
  • Patients unsuitable for standard induction chemotherapy.
  • Patients who have previously undergone or will be able to undergo allogeneic transplantation.
  • Patients who have had previous or current treatment with any form of investigational immunotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

July 10, 2015

Study Start

May 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 13, 2017

Record last verified: 2017-04