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
Verified date | April 2017 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
King's College London | King's College Hospital NHS Trust |
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 |
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