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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Ulrich Duehrsen, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT00554164
First received: November 5, 2007
Last updated: February 4, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University Hospital, Essen:

Primary Outcome Measures:
  • Time to treatment failure [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate, overall survival, disease-free survival, toxicity, quality of life [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 696
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Essen

Additional 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
Study First Received: November 5, 2007
Last Updated: February 4, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014