Lymphoma, High-gradePhase 3PETALNCT00554164
Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas
A Phase 3 study testing (R-)CHOP protocol and B-ALL protocol in people with Lymphoma, High-grade, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma, High-grade
- What is being tested?
- (R-)CHOP protocol and B-ALL protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,073 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Hematology, University Hospital Essen
Essen, 45122
About this study
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.
Read the 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).
- Conditions
- Lymphoma, High-grade
- Being tested
- (R-)CHOP protocol, B-ALL protocol
- Keywords
- Aggressive non-Hodgkin's lymphoma, Positron emission tomography, Chemotherapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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).
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).
(R-)CHOP protocolDrug
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.
(R-)CHOP protocolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| B1 | Active comparator | Six cycles of the (R-)CHOP regimen. Receives: Drug: (R-)CHOP protocol |
| B2 | Experimental | Six blocks of the B-ALL protocol. Receives: Drug: B-ALL protocol |
| A1 | Active comparator | Four cycles of the (R-)CHOP regimen. Receives: Drug: (R-)CHOP protocol |
| A2 | Active comparator | Four cycles of the (R-)CHOP regimen plus two additional doses rituximab. Receives: Drug: (R-)CHOP protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Measured: Two years
Secondary outcomes (1)
Response rate, overall survival, disease-free survival, toxicity, quality of life
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, High-gradeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Principal investigator, Ulrich Duehrsen, University Hospital, Essen
- Investigators
- Ulrich Duehrsen, Prof. Dr., Principal investigator, Department of Hematology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554164
- Sponsor's protocol ID
- PETAL trial
- Other IDs
- EudraCT-Number 2006-001641-33, Krebshilfe Grant 107592
- Acronym
- PETAL
- Status last verified
- May 2017
- First submitted
- 5 Nov 2007
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40453056Duhrsen 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.
PubMed 40397196Broecker-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.
PubMed 34708297Kaddu-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.
PubMed 33928400Schmitz 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.
PubMed 32022621Schmitz 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.
PubMed 31710995Kurtz 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.
PubMed 30125215Duhrsen 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.
PubMed 29750632Huttmann 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.
PubMed 20644097Duhrsen 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.
PubMed 19863177
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00554164
- Acronym / sponsor ID
- PETAL / PETAL trial
- Conditions
- Lymphoma, High-grade
- Keywords
- Aggressive non-Hodgkin's lymphoma, Positron emission tomography, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,073 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Nov 2007
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B1 | Active comparator | Drug: (R-)CHOP protocolSix cycles of the (R-)CHOP regimen. |
| B2 | Experimental | Drug: B-ALL protocolSix blocks of the B-ALL protocol. |
| A1 | Active comparator | Drug: (R-)CHOP protocolFour cycles of the (R-)CHOP regimen. |
| A2 | Active comparator | Drug: (R-)CHOP protocolFour cycles of the (R-)CHOP regimen plus two additional doses rituximab. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (R-)CHOP protocolPatients 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). | Drug | B1 |
| B-ALL protocolPatients 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). | Drug | B2 |
| (R-)CHOP protocolPatients 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. | Drug | A1 |
| (R-)CHOP protocolPatients 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. | Drug | A2 |
Primary outcome
Time to treatment failure
Time frame: Two years
1 secondary outcome
Response rate, overall survival, disease-free survival, toxicity, quality of life
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 40453056Duhrsen 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.
- Derived from this study: PubMed 40397196Duhrsen 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.
- Derived from this study: PubMed 34708297Broecker-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.
- Derived from this study: PubMed 33928400Kaddu-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.
- Derived from this study: PubMed 32022621Schmitz 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.
- Derived from this study: PubMed 31710995Schmitz 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.
- Derived from this study: PubMed 30125215Kurtz 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.
- Derived from this study: PubMed 29750632Duhrsen 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.
- Derived from this study: PubMed 20644097Huttmann 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.
- Derived from this study: PubMed 19863177Duhrsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Duehrsen, Prof. Dr. principal investigator
Department of Hematology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (R-)CHOP protocol and B-ALL protocol in people with Lymphoma, High-grade, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00554164, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.