AT9283 in Treating Young Patients With Relapsed or Refractory Acute Leukemia (NCT01431664) | Clinical Trial Compass
CompletedPhase 1
AT9283 in Treating Young Patients With Relapsed or Refractory Acute Leukemia
United Kingdom7 participantsStarted 2011-09
Plain-language summary
RATIONALE: AT9283 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/IIa clinical trial is studying the side effects and best dose of AT9283 in treating young patients with relapsed or refractory acute leukemia.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed acute leukemia according to the following criteria:
* Acute lymphoblastic leukemia (ALL) meeting any of the following criteria:
* Second relapse
* Refractory to induction therapy for first relapse
* Third or subsequent relapse
* Acute myeloid leukemia (AML) meeting any of the following criteria:
* Second or subsequent relapse
* Refractory to an induction therapy for first relapse
* Without a curative treatment option
* Other type of acute leukemia meeting any of the following criteria:
* First or subsequent relapse
* Refractory to induction therapy
* Not eligible for any therapy of higher curative potential
* No chronic myeloid leukemia (CML)
* Patients in relapse must have ≥ 5% blasts in the bone marrow
* Patients with refractory disease following induction must have ≥ 20% blasts in the bone marrow
* No evidence of CNS disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% OR Lansky PS 50-100%
* Life expectancy ≥ 8 weeks
* Serum bilirubin \< 1.5 times upper limit of normal (ULN)
* ALT or AST \< 2.5 times ULN (5 times ULN if due to leukemic infiltration of the liver)
* Creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use 2 of the following combined forms of contraception (oral, injected, or implanted hormonal contraception and condom OR intra-uterine device and condom OR diaphragm with spe…
What they're measuring
1
Maximum-tolerated dose and recommended phase II dose of multikinase inhibitor AT9283