Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Biological: epratuzumab; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate

• Registration Number: NCT00301821
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed Description

OBJECTIVES:\> Primary\>

* Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.\>

* Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.\>

* Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.\>

* Assess the safety of this treatment regimen.\> Secondary\>

* Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.\> OUTLINE: This is a multicenter study.\> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\> After completion of study treatment, patients are followed periodically for up to 5 years.\> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.\>

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-13
• Primary Completion: 2008-10
• Results First Submitted: 2015-03-13
• Results First Submitted QC: 2015-03-13
• Results First Posted: 2015-03-24
• Study Completion: 2015-04
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epratuzumab + Rituximab + CHOP	vincristine sulfate	One arm open label.
Epratuzumab + Rituximab + CHOP	epratuzumab	One arm open label.
Epratuzumab + Rituximab + CHOP	rituximab	One arm open label.
Epratuzumab + Rituximab + CHOP	cyclophosphamide	One arm open label.
Epratuzumab + Rituximab + CHOP	prednisone	One arm open label.
Epratuzumab + Rituximab + CHOP	doxorubicin hydrochloride	One arm open label.

Primary Outcome Measures

Name	Time	Method
Event-free Survival After 12 Months	From Baseline to 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

Name	Time	Method
Overall Survival	time from study entry to 36 months	Percentage of participants alive at different time points
Overall Response Rate (ORR)	Baseline to first 6 cycles of treatment	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 (met eligibility criteria, signed consent form, and started treatment). 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.
Progression-free Survival (PFS)	the time from study entry to 36 months	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.

Trial Locations

Locations (159)

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Aurora Presbyterian Hospital; 🇺🇸 Aurora, Colorado, United States

Boulder Community Hospital; 🇺🇸 Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

St. Joseph Hospital; 🇺🇸 Denver, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

CCOP - Colorado Cancer Research Program; 🇺🇸 Denver, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

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