Clinical trial · Interventional
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
NCT00544219CI-TRIAL-00038630completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| positron emission tomography | Procedure | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- R-Chop 14
- description
- Standard treatment
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisone
- Drug: vincristine sulfate
- Procedure: positron emission tomography
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- at 2 years
Secondary outcomes (5)
- measure
- Event-free survival
- timeFrame
- at 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
Inclusion criteria:
* 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
Exclusion criteria:
* Secondary DLBCL (in transformation)
* Evidence of symptomatic CNS disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
* 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
Exclusion criteria:
* 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
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
* Prior chemotherapy, radiotherapy, or immunotherapy (e.g., rituximab) for lymphoma
* Prior anthracycline treatment
* Concurrent radiotherapy
* Concurrent regular corticosteroids in the past 4 weeks
* Doses ≤ 20 mg/day of prednisone for indications other than lymphoma or lymphoma-related symptoms allowed
* Concurrent drugs contraindicated for use with the study drugs according to the Swissmedic-approved product information
* Other concurrent experimental drugs or other anticancer therapyReferences
Publications (5)
- RESULTJuskevicius 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 28302137
- RESULTMamot 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 26150440
- RESULTTzankov 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 26071053
- DERIVEDMendeville 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 39747123
- DERIVEDCeriani 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.