PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study
5 other identifiers
interventional
156
2 countries
19
Brief Summary
RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lymphoma
Started Sep 2007
Longer than P75 for not_applicable lymphoma
19 active sites
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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 13, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMay 15, 2019
May 1, 2019
5 years
October 13, 2007
May 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free survival
at 2 years
Secondary Outcomes (5)
Event-free survival
at 5 years
Overall survival during follow-up
at 2 and 5 years
Objective response
at 2 years
Positron emission tomography (PET) results
at 2 years
Histological results of remaining PET-positive lesion(s) after treatment
at 2 years
Study Arms (1)
R-Chop 14
OTHERStandard treatment
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of CD20+ diffuse large B-cell lymphoma (DLBCL)
- Stage I-IV disease
- All IPI risk groups
- Must be positron emission tomography (PET)-positive
- At least one measurable lesion ≥ 15 mm in its shortest axis (greatest transverse diameter) for jugulodigastric and infra-carinal lymph nodes with CT scan (MRI is allowed only if CT scan cannot be performed)
- Otherwise the shortest axis (greatest transverse diameter) must be ≥ 10 mm
- Lesions should be selected according to the following features:
- Clearly measurable in two perpendicular dimensions
- From as disparate regions of the body as possible
- Include mediastinal and retroperitoneal areas of disease whenever these sites are involved
You may not qualify if:
- Secondary DLBCL (in transformation)
- Evidence of symptomatic CNS disease
- PATIENT CHARACTERISTICS:
- ECOG or WHO performance status 0-2
- Cardiac ejection fraction ≥ 50% as assessed by echocardiography
- Sufficient hematological values, hepatic and renal function
- Patient condition, compliance, and geographic proximity must allow proper staging and completion of treatment and follow-up
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study therapy
- Prior or concurrent hematological malignancies
- Patients who have had prior solid organ tumors that required no treatment over the past 5 years and are currently disease-free are allowed
- Unstable cardiac disease within the past 6 months
- Any serious underlying medical condition (at the judgment of the investigator) that could impair the ability of the patient to participate in the study (e.g., active autoimmune disease, uncontrolled diabetes, HIV- and hepatitis-infection)
- Known hypersensitivity to any component of the study drugs
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
European Institute of Oncology
Milan, 20141, Italy
Hirslanden Klinik Aarau
Aarau, CH-5001, Switzerland
Kantonspital Aarau
Aarau, CH-5001, Switzerland
Kantonsspital Baden
Baden, CH-5404, Switzerland
Praxis Dr. Streit
Baden, CH-5404, Switzerland
Saint Claraspital AG
Basel, CH-4016, Switzerland
Universitaetsspital-Basel
Basel, CH-4031, Switzerland
Oncology Institute of Southern Switzerland
Bellinzona, CH-6500, Switzerland
Inselspital Bern
Bern, CH-3010, Switzerland
Kantonsspital Bruderholz
Bruderholz, CH-4101, Switzerland
Kantonsspital Graubuenden
Chur, CH-7000, Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211, Switzerland
Kantonsspital Liestal
Liestal, CH-4410, Switzerland
Kantonsspital Olten
Olten, CH-4600, Switzerland
Praxis Dr. Beretta
Rheinfelden, CH-4310, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007, Switzerland
Regionalspital
Thun, 3600, Switzerland
Kantonsspital Winterthur
Winterthur, CH-8400, Switzerland
UniversitaetsSpital Zuerich
Zurich, CH-8091, Switzerland
Related Publications (5)
Juskevicius D, Jucker D, Klingbiel D, Mamot C, Dirnhofer S, Tzankov A. Mutations of CREBBP and SOCS1 are independent prognostic factors in diffuse large B cell lymphoma: mutational analysis of the SAKK 38/07 prospective clinical trial cohort. J Hematol Oncol. 2017 Mar 17;10(1):70. doi: 10.1186/s13045-017-0438-7.
PMID: 28302137RESULTMamot C, Klingbiel D, Hitz F, Renner C, Pabst T, Driessen C, Mey U, Pless M, Bargetzi M, Krasniqi F, Gigli F, Hany T, Samarin A, Biaggi C, Rusterholz C, Dirnhofer S, Zucca E, Martinelli G. Final Results of a Prospective Evaluation of the Predictive Value of Interim Positron Emission Tomography in Patients With Diffuse Large B-Cell Lymphoma Treated With R-CHOP-14 (SAKK 38/07). J Clin Oncol. 2015 Aug 10;33(23):2523-9. doi: 10.1200/JCO.2014.58.9846. Epub 2015 Jul 6.
PMID: 26150440RESULTTzankov A, Leu N, Muenst S, Juskevicius D, Klingbiel D, Mamot C, Dirnhofer S. Multiparameter analysis of homogeneously R-CHOP-treated diffuse large B cell lymphomas identifies CD5 and FOXP1 as relevant prognostic biomarkers: report of the prospective SAKK 38/07 study. J Hematol Oncol. 2015 Jun 14;8:70. doi: 10.1186/s13045-015-0168-7.
PMID: 26071053RESULTMendeville MS, Janssen J, Los-de Vries GT, van Dijk E, Richter J, Nijland M, Roemer MGM, Stathi P, Hijmering NJ, Bladergroen R, Pelaz DA, Diepstra A, Eertink CJ, Burggraaff CN, Kim Y, Lugtenburg PJ, van den Berg A, Tzankov A, Dirnhofer S, Duhrsen U, Huttmann A, Klapper W, Zijlstra JM, Ylstra B, de Jong D. Integrating genetic subtypes with PET scan monitoring to predict outcome in diffuse large B-cell lymphoma. Nat Commun. 2025 Jan 2;16(1):109. doi: 10.1038/s41467-024-55614-y.
PMID: 39747123DERIVEDCeriani L, Gritti G, Cascione L, Pirosa MC, Polino A, Ruberto T, Stathis A, Bruno A, Moccia AA, Giovanella L, Hayoz S, Schar S, Dirnhofer S, Rambaldi A, Martinelli G, Mamot C, Zucca E. SAKK38/07 study: integration of baseline metabolic heterogeneity and metabolic tumor volume in DLBCL prognostic model. Blood Adv. 2020 Mar 24;4(6):1082-1092. doi: 10.1182/bloodadvances.2019001201.
PMID: 32196557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christoph Mamot, MD
Kantonsspital Aarau
- STUDY CHAIR
Mario Bargetzi, MD
Kantonsspital Aarau
- STUDY CHAIR
Giovanni Martinelli, MD
European Institute of Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2007
First Posted
October 16, 2007
Study Start
September 1, 2007
Primary Completion
September 1, 2012
Study Completion
January 1, 2016
Last Updated
May 15, 2019
Record last verified: 2019-05