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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554164
First Posted: November 6, 2007
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Ulrich Duehrsen, University Hospital, Essen
  Purpose
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.

Condition Intervention Phase
Lymphoma, High-grade Drug: (R-)CHOP protocol Drug: B-ALL protocol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas

Resource links provided by NLM:


Further study details as provided by Ulrich Duehrsen, University Hospital, Essen:

Primary Outcome Measures:
  • Time to treatment failure [ Time Frame: Two years ]

Secondary Outcome Measures:
  • Response rate, overall survival, disease-free survival, toxicity, quality of life [ Time Frame: Two years ]

Enrollment: 1073
Study Start Date: November 2007
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B1
Six cycles of the (R-)CHOP regimen.
Drug: (R-)CHOP protocol
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).
Experimental: B2
Six blocks of the B-ALL protocol.
Drug: B-ALL protocol
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).
Active Comparator: A1
Four cycles of the (R-)CHOP regimen.
Drug: (R-)CHOP protocol
Patients with a negative interim-PET scan assigned to arm A1 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone). Arm A1 was closed when the number of patients required for the randomisation between arms A1 and A2 was reached.
Active Comparator: A2
Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.
Drug: (R-)CHOP protocol
Patients with a negative interim-PET scan assigned to arm A2 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone) plus two additional doses rituximab. Since the number of patients required for the randomisation between arms A1 and A2 has been reached, all patients with a negative interim-PET scan are treated according to arm A2.

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554164


Locations
Germany
Department of Hematology, University Hospital Essen
Essen, Germany, 45122
Sponsors and Collaborators
University Hospital, Essen
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Principal Investigator: Ulrich Duehrsen, Prof. Dr. Department of Hematology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrich Duehrsen, Prof. Dr. Ulrich Duehrsen, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT00554164     History of Changes
Other Study ID Numbers: PETAL trial
EudraCT-Number 2006-001641-33
Krebshilfe Grant 107592
First Submitted: November 5, 2007
First Posted: November 6, 2007
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Ulrich Duehrsen, University Hospital, Essen:
Aggressive non-Hodgkin's lymphoma
Positron emission tomography
Chemotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Rituximab
Cyclophosphamide
Doxorubicin
Prednisone
Vincristine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids