Acute Myeloid Leukemia, AML
Conditions
Keywords
acute myeloid leukemia, AML
Brief summary
This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.
Interventions
DRUGXL999
XL999 was administered at a dose of 2.4 mg/kg given as a 4-hour IV infusion weekly for 4 weeks. In the absence of progressive disease and unacceptable toxicity, subjects were to receive XL999 treatment weekly for up to 1 year on this study
Sponsors
Symphony Evolution, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia \[APL\]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy) * ECOG performance status of 0 or 1 * Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens. * Adequate liver and renal function * Signed informed consent
Exclusion criteria
* Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment * Hematopoietic stem cell transplantation within the previous 6 weeks * Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999 * The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered \> 4 weeks prior to study enrollment * Uncontrolled and/or concomitant illness * Pregnant or breastfeeding females * Known HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic and cytogenetic response rate | Inclusion until disease progression |
| Safety and tolerability | Inclusion until 30 dyas post last treatment |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hematologic response and transfusion independence | Inclusion until disease progression |
| Progression-free survival | Inclusion until disease progression |
| Overall survival | Inclusion until 180-day Follow-up post last treatment or death |
Countries
United States
Outcome results
None listed