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Lymphoma (Non-Hodgkins)

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Unique Data Set IDLymphom_Allianc_2006_212
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients107Experimental (Active) Arm Enrolled Patients107RandomizationNoClinicalTrial.gov IDNCT00301821ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/record/NCT00301821?term=N0489&rank=1&view=results
Study PhaseClinical Study Phase IIBBlinding MethodOpen Label StudyType(s) of dataOnly experimental arm dataIntervention TypeBiologics, DrugData Set TypeADS

Clinical Trial Title

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Trial Summary and Conditions

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

To prospectively assess the efficacy of combination of CHOP with epratuzumab and rituximab (ER-CHOP), as measured by 12-month, event-free survival (EFS12), in patients with previously untreated stages II, III, and IV diffuse large B-cell lymphoma. To assess the use of PET scan routinely early in treatment and post-completion of chemotherapy and thereby assess the functional CR rate (CR/PR or stable by CT scan and PET negative). To assess the safety of ER-CHOP.

Outcome Measures

Primary Outcome Measures: Event-free Survival After 12 Months The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12). Secondary Outcome Measures: Overall Survival Percentage of participants alive at different time points Progression-free Survival (PFS) Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. Overall Response Rate (ORR) Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: N0489Prot_06Aug2008.pdf

CRF: FormsPacket_21Sep2007.pdf

DATA DICTIONARY: n0489_datasphere_datadictionary.docx

DATA (ACTIVE ARM): outcome17mar24.sas7bdat

DATA (ACTIVE ARM): events.sas7bdat