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BP1001 in Combination with Low-dose Cytarabine (LDAC) in Patients with Previously Untreated (AML) Who Are Ineligible for Induction Therapy

Clinical Trial Details

The goal of this clinical research study is to assess whether the combination of BP1001 and cytarabine provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete hematologic recovery [CRi], Complete Remission with incomplete platelet recovery [CRp]) than cytarabine alone (by historical comparison) in participants with AML that cannot or elect not to be treated with more intensive chemotherapy.

BP1001 is an investigational drug, meaning that it hasn’t been approved yet by the FDA. It is an antisense drug, which means it may help stop cancer cells by blocking the action of a protein that signals cancer cells to divide and increase in number. The protein that BP1001 blocks is called Grb2. The response of the leukemia to the BP1001 cytarabine combination will be studied. In addition, the time needed for the body to process BP1001 will be evaluated. 

Key Eligibility: 
  • Adults 18 years of age or older
  • Histologically documented diagnosis of newly diagnosed de novo acute myeloid leukemia (AML), or untreated secondary AML
  • Subject is ineligible for (or unwilling to receive) intensive induction therapy based on medical reasons, disease characteristics such as genetics, type of AML or participant characteristics
  • Eligible for low-dose cytarabine therapy
  • Adequate hepatic and renal function 

Detailed eligibility criteria will be discussed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1607017388

Sponsor:

BP1001-201-AML

Status

Open to Enrollment

Age Group

Adult

Sponsor