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Status:

COMPLETED

AT9283 in Treating Young Patients With Relapsed or Refractory Acute Leukemia

Lead Sponsor:

Cancer Research UK

Conditions:

Leukemia

Eligibility:

All Genders

Up to 18 years

Phase:

PHASE1

Brief 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 AT...

Detailed Description

OBJECTIVES: Primary * To identify the maximum-tolerated dose and recommended phase IIb dose of multikinase inhibitor AT9283 in pediatric patients with relapsed or refractory acute leukemia. Seconda...

Eligibility Criteria

Inclusion

  • 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 spermicidal gel and condom) before, during, and for 6 months after completion of study therapy
  • Male patients must use 1 form of highly effective contraception (condom plus spermicidal gel) during and for 6 months after completion of study therapy
  • Men with pregnant or lactating partners should be advised to use barrier-method contraception (condom plus spermicidal gel)
  • No serological positivity for hepatitis B, hepatitis C, or HIV
  • No congenital heart disease, with the exception of patent foramen ovale or small muscular ventricular septal deficit (within the first year of life)
  • No uncontrolled arterial hypertension (defined as a systolic blood pressure \[BP\] and/or diastolic BP ≥ 95th percentile for age and height)
  • No fractional shortening of ≤ 29% on echocardiogram
  • No active graft-vs-host disease
  • No current non-malignant systemic disease considered high medical risk, including any of the following:
  • Active uncontrolled infection
  • Unstable or uncompensated respiratory or cardiac condition that makes study participation undesirable
  • No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial
  • PRIOR CONCURRENT THERAPY:
  • Recovered from toxicity of prior therapy, including toxicity following hematopoietic stem cell transplantation
  • Alopecia or certain grade 1 toxicities allowed at the discretion of the Investigator
  • A maximum of 2 days of hydroxycarbamide 10-20 mg/kg/day (or according to local practice) in patients with AML and hyperleukocytosis allowed
  • At least 7 days since prior investigational drugs (except antibodies for which a 4-week window must be observed)
  • At least 7 days since prior protein kinase inhibitors and intrathecal therapy
  • Concurrent intrathecal therapy allowed from course 2 onwards in patients with ALL
  • At least 14 days since prior cytotoxic therapy, including vincristine and other anti-neoplastics
  • No prior major thoracic or abdominal surgery from which the patient has not yet recovered
  • No prior aurora kinase inhibitor
  • No concurrent steroid therapy
  • Multikinase inhibitor AT9283 administration may be commenced once steroids have started; however, steroids may not be started once multikinase inhibitor AT9283 has started
  • Up to 5 days of prior oral dexamethasone (6 mg/m\^2) for patients with ALL experiencing a rapid rise in blast count allowed
  • No other concurrent interventional clinical study
  • Participation in an observational study allowed
  • No other concurrent anticancer therapy or investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    September 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2014

    Estimated Enrollment :

    7 Patients enrolled

    Trial Details

    Trial ID

    NCT01431664

    Start Date

    September 1 2011

    End Date

    July 1 2014

    Last Update

    December 2 2014

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Royal Marsden Hospital

    Surrey, London, United Kingdom, SM2 5PT

    2

    Birmingham Children's Hospital

    Birmingham, United Kingdom, B4 6NH

    3

    Leeds General Infirmary

    Leeds, United Kingdom, LS1 3EX

    4

    Royal Manchester Children's Hospital

    Manchester, United Kingdom, M13 9WL