EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblasti… (NCT01186328) | Clinical Trial Compass
TerminatedPhase 1
EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)
Stopped: Enzon Pharmaceuticals decided to end its development of EZN-3042.
United States6 participantsStarted 2010-08-24
Plain-language summary
An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is to find out the dose of EZN-3042 that can be safely given without serious side effects both alone and in combination with standard chemotherapy drugs during re-induction.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion Criteria:
* Patients must be ≥1 and ≤ 21 years of age when originally diagnosed with acute lymphoblastic leukemia (ALL).
* Patients must have relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease.
* Patients may have central nervous system 1, 2 or 3 disease.
* Karnofsky Performance Level ≥ 50 for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age.
* Patients must have had 2 or more prior therapeutic attempts defined as:
* Relapse after going into remission from re-induction for the first or subsequent relapse (ie: 2nd , 3rd, 4th…relapse), or
* Refractory disease after first or greater relapse and a single re-induction attempt. \*Please note, Enrollment will be restricted to at most one refractory patient in each cohort of 3 patients per dose level.
* Patients with ALL who are refractory to frontline induction therapy are not eligible.
* Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study.
* Patients who relapse when they are not receiving standard ALL maintenance therapy must have fully recovered from grade 3 or 4 toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
* Cytotoxic Therapy: It must be at least 14 days since the completion of cytotoxic therapy (excluding hydroxyurea) at the time of s…
What they're measuring
1
Maximum Tolerated Dose of EZN-3042
Timeframe: 2 months
Trial details
NCT IDNCT01186328
SponsorTherapeutic Advances in Childhood Leukemia Consortium