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Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML


In this phase II trial HLA-A2+ patients with active AML without curative treatment option
are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and
GM-CSF 4 times bi-weekly, then monthly.


Inclusion Criteria:



- AML or myelodysplastic syndromes (MDS)

- Partial response (PR) or complete response (CR) or smoldering course without option
for allogeneic stem cell transplantation

- HLA-A2+

- WT1-expression in bone marrow

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Generation of T cell response

Principal Investigator

Ulrich Keilholz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

HaemaCBFWT102

NCT ID:

NCT00153582

Start Date:

April 2002

Completion Date:

Related Keywords:

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

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