B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

Phase 1

• Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
• Interventions: Biological: AML Cell Vaccine

• Registration Number: NCT02493829
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13
• Study Start: 2017-05
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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).

Key

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AML Cell Vaccine	AML Cell Vaccine	-

Primary Outcome Measures

Name	Time	Method
Vaccine-related toxicity based on the NCI criteria V4.0	52 weeks
Frequency, severity of adverse events to the AML cell vaccine	52 weeks