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Completed

NCT Number: NCT00554164

Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas

The main purpose of the PETAL trial is to determine whether patients with aggressive non-Hodgkin's lymphomas with a persistently positive PET scan after two cycles of chemotherapy benefit from a change of the treatment protocol.

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Key information

Conditions

Lymphoma, High-grade Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Hematology, University Hospital Essen

Essen, 45122, Germany

About this study

Positron emission tomography performed after two cycles of (R-)CHOP chemotherapy (interim-PET) has been shown to predict long-term outcome in patients with aggressive non-Hodgkin's lymphomas. Patients with early normalization of pathological PET findings have an excellent prognosis, while patients with a persistently pathological PET scan have a high risk of non-response or relapse.

Patients with a negative interim-PET scan (part A of the trial) will be randomized to receive either another four cycles of the (R-)CHOP regimen (arm A1) or four cycles of the (R-)CHOP regimen plus two additional doses of rituximab (arm A2). Randomisation in part A of the trial was stopped when the number of patients required was reached (128 patients in each treatment arm). Since then patients have been uniformly treated according to arm A2.

Patients with a persistently positive interim-PET scan (part B of the trial) will be randomized to either continue treatment with another six (R-)CHOP cycles (arm B1) or switch to an alternative protocol used for the treatment of Burkitt's lymphoma (arm B2: six blocks according to the so-called B-ALL protocol of the German ALL study group).

Patients refractory to or relapsing within two years after treatment according to parts A or B of the trial will receive age-adapted salvage protocols (patients < 60 years: high-dose chemotherapy with autologous stem cell transplantation; patients > 60 years: (R-)ESHAP protocol)(part C of the trial).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aggressive B-cell or T-cell non-Hodgkin's lymphoma
  • Pathological pre-treatment PET scan
  • Performance status ECOG 0-3
  • Age 18 - 80 years
  • Ability to understand the purpose of the study and act accordingly
  • Willingness to use adequate contraception
  • Informed consent

Exclusion criteria

  • Burkitt's lymphoma
  • Primary central nervous system lymphoma
  • Previous chemo- and/or radiotherapy
  • Other cancer within preceding 5 years
  • HIV infection, active viral hepatitis or other uncontrolled infection
  • Other medical conditions precluding administration of planned therapy
  • Pregnancy or lactation

Treatment and study plan

(R-)CHOP protocol

Drug

Patients with a persistently positive interim-PET scan assigned to arm B1 will receive another six cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone).

B-ALL protocol

Drug

Patients with a persistently positive interim-PET scan assigned to arm B2 will receive six blocks of the B-ALL protocol (rituximab, methotrexate, ifosfamide, etoposide, cytarabine, vincristine, cyclophosphamide, doxorubicine, vindesine, dexamethasone).

Primary outcomes

  1. Time to treatment failure

    Time frame: Two years

Secondary outcomes

  1. Response rate, overall survival, disease-free survival, toxicity, quality of life

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Acronym: PETAL

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2007
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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