NCT00554164

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,073

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

9.3 years

First QC Date

November 5, 2007

Last Update Submit

May 4, 2017

Conditions

Lymphoma, High-grade

Keywords

Aggressive non-Hodgkin's lymphomaPositron emission tomographyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Time to treatment failure

    Two years

Secondary Outcomes (1)

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

    Two years

Study Arms (4)

B1

ACTIVE COMPARATOR

Six cycles of the (R-)CHOP regimen.

Drug: (R-)CHOP protocol

B2

EXPERIMENTAL

Six blocks of the B-ALL protocol.

Drug: B-ALL protocol

A1

ACTIVE COMPARATOR

Four cycles of the (R-)CHOP regimen.

Drug: (R-)CHOP protocol

A2

ACTIVE COMPARATOR

Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.

Drug: (R-)CHOP protocol

Interventions

(R-)CHOP protocolDRUG

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).

B1
B-ALL protocolDRUG

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).

B2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, University Hospital Essen

Essen, 45122, Germany

Location

Related Publications (10)

  • Duhrsen U, Bockisch A, Hertenstein B, Karsten IE, Kroschinsky F, Heuser M, Hochhaus A, Hoffkes HG, Behringer D, Prange-Krex G, Tometten M, Grieshammer M, Grigoleit GU, Schmalz O, Jordan K, Bernhard H, Gaska T, Giagounidis A, Schroers R, Martens UM, Held G, Klapper W, Jockel KH, Nonnemacher M, Huttmann A; PETAL Trial Investigators. Response-guided first-line therapy and treatment of relapse in aggressive lymphoma: 10-year follow-up of the PETAL trial. Blood Neoplasia. 2024 May 21;1(3):100018. doi: 10.1016/j.bneo.2024.100018. eCollection 2024 Sep.

    PMID: 40453056DERIVED

  • Duhrsen U, Prange-Krex G, Moeller R, Held H, Heil G, Schwarzer A, Mahlmann S, Dienst A, Sandmann M, Maschmeyer G, Schutte J, Hahn D, Heike M, Nonnemacher M, Hanoun C, Huttmann A; PETAL trial investigators. Health-related quality of life in patients with aggressive non-Hodgkin lymphoma: results from the PETAL trial. Ann Hematol. 2025 May;104(5):2831-2845. doi: 10.1007/s00277-025-06402-1. Epub 2025 May 21.

    PMID: 40397196DERIVED

  • Broecker-Preuss M, Becher-Boveleth N, Muller SP, Huttmann A, Hanoun C, Grafe H, Richter J, Klapper W, Rekowski J, Bockisch A, Duhrsen U. Impact of germline polymorphisms in genes regulating glucose uptake on positron emission tomography findings and outcome in diffuse large B-cell lymphoma: results from the PETAL trial. J Cancer Res Clin Oncol. 2022 Oct;148(10):2611-2621. doi: 10.1007/s00432-021-03796-z. Epub 2021 Oct 27.

    PMID: 34708297DERIVED

  • Kaddu-Mulindwa D, Altmann B, Held G, Angel S, Stilgenbauer S, Thurner L, Bewarder M, Schwier M, Pfreundschuh M, Loffler M, Menhart K, Grosse J, Ziepert M, Herrmann K, Duhrsen U, Huttmann A, Barbato F, Poeschel V, Hellwig D. FDG PET/CT to detect bone marrow involvement in the initial staging of patients with aggressive non-Hodgkin lymphoma: results from the prospective, multicenter PETAL and OPTIMAL>60 trials. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3550-3559. doi: 10.1007/s00259-021-05348-6. Epub 2021 Apr 29.

    PMID: 33928400DERIVED

  • Schmitz C, Rekowski J, Reinke S, Muller SP, Huttmann A, Klapper W, Duhrsen U. Metabolic tumor volume, cancer cell fraction, and prognosis - the case of T-cell/histiocyte-rich large B-cell lymphoma. Leuk Lymphoma. 2020 Jun;61(6):1372-1379. doi: 10.1080/10428194.2020.1713319. Epub 2020 Feb 5.

    PMID: 32022621DERIVED

  • Schmitz C, Huttmann A, Muller SP, Hanoun M, Boellaard R, Brinkmann M, Jockel KH, Duhrsen U, Rekowski J. Dynamic risk assessment based on positron emission tomography scanning in diffuse large B-cell lymphoma: Post-hoc analysis from the PETAL trial. Eur J Cancer. 2020 Jan;124:25-36. doi: 10.1016/j.ejca.2019.09.027. Epub 2019 Nov 9.

    PMID: 31710995DERIVED

  • Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20.

    PMID: 30125215DERIVED

  • Duhrsen U, Muller S, Hertenstein B, Thomssen H, Kotzerke J, Mesters R, Berdel WE, Franzius C, Kroschinsky F, Weckesser M, Kofahl-Krause D, Bengel FM, Durig J, Matschke J, Schmitz C, Poppel T, Ose C, Brinkmann M, La Rosee P, Freesmeyer M, Hertel A, Hoffkes HG, Behringer D, Prange-Krex G, Wilop S, Krohn T, Holzinger J, Griesshammer M, Giagounidis A, Raghavachar A, Maschmeyer G, Brink I, Bernhard H, Haberkorn U, Gaska T, Kurch L, van Assema DME, Klapper W, Hoelzer D, Geworski L, Jockel KH, Scherag A, Bockisch A, Rekowski J, Huttmann A; PETAL Trial Investigators. Positron Emission Tomography-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL): A Multicenter, Randomized Phase III Trial. J Clin Oncol. 2018 Jul 10;36(20):2024-2034. doi: 10.1200/JCO.2017.76.8093. Epub 2018 May 11.

    PMID: 29750632DERIVED

  • Huttmann A, Muller S, Jockel KH, Duhrsen U. Pitfalls of interim positron emission tomography scanning in diffuse large B-cell lymphoma. J Clin Oncol. 2010 Sep 20;28(27):e488-9; author reply e490-1. doi: 10.1200/JCO.2010.29.5428. Epub 2010 Jul 19. No abstract available.

    PMID: 20644097DERIVED

  • Duhrsen U, Huttmann A, Jockel KH, Muller S. Positron emission tomography guided therapy of aggressive non-Hodgkin lymphomas--the PETAL trial. Leuk Lymphoma. 2009 Nov;50(11):1757-60. doi: 10.3109/10428190903308031.

    PMID: 19863177DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

R-CHOP protocol

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ulrich Duehrsen, Prof. Dr.

    Department of Hematology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Ulrich Duehrsen

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

DE(1)