NECTAR

  • Research type

    Research Study

  • Full title

    A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC

  • IRAS ID

    112371

  • Contact name

    Bridget Large

  • Contact email

    NECTAR@trials.bham.ac.uk

  • Sponsor organisation

    Therapeutic Advances in Childhood Leukemia & Lymphoma

  • Eudract number

    2011-005923-42

  • Clinicaltrials.gov Identifier

    NCT00981799

  • Clinicaltrials.gov Identifier

    RG_12-246, University of Birmingham Reference; HM1015, CRCTU Internal Reference

  • Duration of Study in the UK

    1 years, 3 months, 31 days

  • Research summary

    This is a trial for patients who have relapsed T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LL).

    The trial is currently recruiting to the maxiumum tolerated dose (MTD) cohort. Therefore T-LL patients are excluded.

    Patients with T-ALL and bone marrow relapse, or T-LL, have a poor prognosis regardless of time to relapse. The possibility of long term survival is greatly increased by stem cell transplantation (HSCT); however remission needs to be attained before stem cell transplantation can be considered. Currently remission rates are low. It is believed that the effectiveness of the current treatments can be improved.
    Nelarabine is a chemotherapy drug which is used to treat children and adults with relapsed or refractory T-ALL or T-LL. Nelarabine has not been tested in combination with the other chemotherapy drugs used in this study. The trial aims to find out what the best dose of nelarabine is, when given as a combination therapy. In this trial nelarabine will be given with two other chemotherapy drugs, cyclophosphamide and etoposide that are known to be effective in this disease. The goal is to find out the doses of nelarabine, etoposide and cyclophosphamide that can be safely given for 5 days to patients with relapsed T-ALL and T-LL.
    In this trial up to 36 patients aged between 1 and 21 will be recruited across several countries. In the UK the trial will be opened at three centres and will recruit 4 to 5 patients over 24 months.

    Patients must have either T- ALL or T- LL in first relapse or must have failed primary induction therapy (i.e. never attained a complete remission following initial course of standard therapy for T-ALL).

    Patients will receive the MTD as determined by the initial phase of the study.

    Patients will receive a maximum of two courses of therapy, each lasting 36 days. Patients will be closely monitored throughout the treatment period and will stop treatment if they experience disease progression or unacceptable toxicities associated with the treatment.

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference

    15/EM/0113

  • Date of REC Opinion

    30 Apr 2015

  • REC opinion

    Further Information Favourable Opinion