Pralatrexate in peripheral T-cell lymphoma (version 1.0)

• Research type

  Research Study

• Full title

  A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Not Progressed Following Initial Treatment with CHOP-based Chemotherapy

• IRAS ID

  65196

• Contact name

  Simon Rule

• Sponsor organisation

  Allos Therapeutics, Inc.

• Eudract number

  2010-022230-81

• ISRCTN Number

  ISRCTN

• Research summary

  Randomised study to investigate the efficacy and safety of pralatrexate versus observation in patients with PTCL who have not progressed following initial treatment with CHOP; the most commonly used chemotherapy for this condition (cyclophosphamide, doxorubicin, vincristine, prednisolone). There can be some minor changes to this combination on how often the drugs are given or addition of one further drug. Minor variations will be referred to as CHOP in this document.PTCLs are aggressive diseases requiring chemotherapy. Treatments that are used to treat PTCL may only work for a short period of time. Thus, new treatments are being tested. Eligibility requires PTCL patients to have received at least 6 cycles of CHOP-based chemotherapy, during which time the disease has not progressed. In addition, central review by a pathologist must confirm that patients have an eligible subtype of PTCL.Once all other eligibility criteria are met, patients are randomly assigned to 1 of 2 treatment groups: pralatrexate or obsevation. In observation, patients return to clinic every 4 weeks for assessment to see if their lymphoma has got worse or come back. This is the standard of care for this disease.In the pralatrexate group, patients receive IV pralatrexate on days 1, 8 and 15 of a 4week cycle. Pralatrexate is an experimental anti-metabolite drug that works in a similar way to methotrexate, a chemotherapy drug used for many years to treat many types of cancer. The primary endpoints for the study are progression-free survival (number of days between randomisation and development of progressive disease) and overall survival. Secondary endpoint is objective response (complete response or partial response) to pralatrexate versus observation.Patients will continue to receive study treatment (pralatrexate or observation) until one of the study discontinuation criteria apply. Patient follow up is for up to 7 years from randomization.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/93

• Date of REC Opinion

  5 Apr 2011

• REC opinion

  Further Information Favourable Opinion