Clinical trial · Interventional
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
NCT00079261CI-TRIAL-00008111completedPhase 2ClinicalTrials.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: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Conditions
Conditions (2)
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 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP regimen | Drug | CHOP Regimen | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete response as assessed by Cheson criteria
Secondary outcomes (3)
- measure
- Toxicity as assessed by CTC 2.0
- measure
- Proportion of courses given as scheduled
- measure
- Freedom from treatment failure as assessed by Cheson criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes: * Diffuse large B large cell lymphoma (including all clinical and morphologic variants) * Grade 3 follicular lymphoma * Extranodal T/NK cell lymphoma, nasal type * Enteropathy-type T cell lymphoma * Hepato-splenic T cell lymphoma * Peripheral T cell lymphoma, unspecified * Angioimmunoblastic lymphoma * Anaplastic large cell lymphoma, systemic type * Stage II-IV disease * At least 1 site of measurable disease (e.g., lymph node or lymph node mass) * The following subtypes are not allowed: * Mantle cell lymphoma * Burkitt's lymphoma * Precursor B or T cell lymphoma * Primary cutaneous B or T cell lymphoma * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * Not specified Life expectancy * Not specified Hematopoietic * WBC \> 3,000/mm\^3 * Neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 2.5 times normal (unless due to lymphoma) * ALT and AST \< 2.5 times normal (unless due to lymphoma) Renal * Creatinine \< 2.0 mg/dL Cardiovascular * No severe cardiac disease that would preclude study participation or limit life expectancy Pulmonary * FEV\_1 and DLCO ≥ 75% of predicted (unless due to lymphoma) * No severe pulmonary disease that would preclude study participation or limit life expectancy Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent monoclonal antibodies Chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * No prior cytotoxic agents * No prior treatment for NHL * No other concurrent anticancer therapy * No other concurrent investigational drugs
References
Publications (1)
- RESULTAurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22. PMID 20942843