Leukaemia, Myelocytic, Acute Clinical Trial
Official title:
Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
The purpose of this study is to evaluate the clinical activity and safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult patients with WT1-positive AML presenting a suboptimal clinical response to induction chemotherapy. The study will also assess whether this treatment induces a specific immune response to the malignancy.
At least 40 patients will be enrolled in this study, divided in two cohorts of 20 patients
each. One cohort will include patients in partial remission after induction therapy and one
cohort will include patients in complete remission but with incomplete blood count recovery.
Patients in both cohorts will receive the same study treatment according to the same
administration schedule.
This protocol summary has been updated according to the Protocol Amendment 3 (dated 10 Sept
2014).
All active follow-up visits and procedures after the concluding visit, 30 days after the last
treatment administration, will be stopped In addition, no more biological samples will be
collected for protocol research purposes. For each biological sample already collected in the
scope of this study and not tested yet, testing will not be performed by default, except if a
scientific rationale remains relevant.Blood sampling for safety monitoring as per protocol
will continue.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 1 | |
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