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

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02493829
• Other study ID #: 2494
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 9, 2015
• Last updated: April 12, 2017
• Start date: May 2017
• Est. completion date: May 2020

Study information

• Verified date: April 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Biological:
• AML Cell Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King's College Hospital NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine-related toxicity based on the NCI criteria V4.0		52 weeks
Primary	Frequency, severity of adverse events to the AML cell vaccine		52 weeks