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Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

C

Cell Genesys

Status and phase

Completed
Phase 2

Conditions

Acute Myelogenous Leukemia

Treatments

Biological: GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.
  • No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

Exclusion criteria

  • Prior myelodysplastic disorder, or treatment-related leukemia.
  • Prior myeloproliferative disease.
  • Acute promyelocytic leukemia (APL).
  • Prior chemotherapy for a malignant or nonmalignant disorder.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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