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Research Programs

Clinical-based Research

Leukemia

Clinical Trials

Significant progress has been made in developing novel agents for clinical translational trials; each of these trials has benefited from rapid accrual due to multi-institutional participation among DF/HCC members, along with the use of Cores such as Biostatistics, Cell Manipulation, DNA Resource, Cytogenetic, and Specialized Histopathology Services.

These trials are each built on preclinical platforms developed within the inter-institutional context of DF/HCC, clearly showing the ability of the DF/HCC infrastructure to facilitate interaction among investigators at disparate sites.

  • Development of small molecule inhibitors of FLT3 (PKC412 and MLN518) for treatment of relapsed AML
  • Development of an up-front protocol for treatment of ALL that incorporates pediatric and adult oncologists and correlative science
  • Use of small molecule kinase inhibitors to treat HES (imatinib) and stem cell leukemia lymphoma syndrome with the ZNF198-FGFR1 fusion (PKC412)
  • Development of -secretase inhibitors for treatment of T-ALL associated with activating mutations in Notch1 in a pediatric/adult ALL consortium trial

During the period January 1, 2000, through December 31, 2004, 2,447 subjects were registered to 116 protocols open for the Leukemia Program. Of these protocols, 96 were intervention studies with 1,648 registrations.

An analysis of accrual patterns by Cancer Center site was performed. Of the Phase 1 and 2 studies that accrued 10 or more subjects (excluding Pediatric, Proton Beam and Cooperative Group Studies), 35% of eligible protocols in this disease program were multi-institutional in accrual by these criteria.

The list of protocols includes 80 non-industry initiated trials open for this program. These protocols account for 69% of all clinical trials in the Leukemia Program and account for 2,021 (83%) of all subject accrual.