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S1001 PET-Directed Therapy in...

S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma

Last Updated: 2025-06-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2023-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as 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. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.

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Detailed Description

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OBJECTIVES:

Primary

* To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).

Secondary

* To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL.
* To evaluate toxicity of the protocol treatments in this patient population.
* To evaluate the response probability in this patient population.
* To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups.
* To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL.
* To describe outcomes in the subgroup of patients upstaged by PET/CT.
* To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no).

Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3\* courses. NOTE: \*Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.

FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.

Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.

Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies.

After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.

Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PET Negative: R-CHOP

R-CHOP x 3 Cycles

Group Type ACTIVE_COMPARATOR

rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

R-CHOP regimen

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

PET Positive: IFRT +Zevalin

Standard IFRT+ Zevalin IV per ABW

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

laboratory biomarker analysis

Intervention Type OTHER

fludeoxyglucose F 18

Intervention Type RADIATION

selective external radiation therapy

Intervention Type RADIATION

yttrium Y 90 ibritumomab tiuxetan

Intervention Type RADIATION

Interventions

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rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

R-CHOP regimen

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

fludeoxyglucose F 18

Intervention Type RADIATION

selective external radiation therapy

Intervention Type RADIATION

yttrium Y 90 ibritumomab tiuxetan

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients must have non-bulky stage I or II disease by Ann Arbor classification

* This staging excludes FDG-PET evaluation
* Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible
* Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration

* Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol
* If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable
* Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma

* Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration
* Patients may have either measurable or evaluable limited-stage DLBCL

* Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible
* If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)
* All measurable disease must be assessed within 28 days prior to registration
* Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
* Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
* Patients must not be pregnant or nursing
* Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period
* Patients must not be known to be HIV-positive
* No other prior malignancy is allowed except for the following:

* Adequately treated basal cell or squamous cell skin cancer
* In situ cervical cancer
* Adequately treated stage I or II cancer from which the patient is currently in complete remission
* Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

* Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel O. Persky, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Providence Cancer Center

Anchorage, Alaska, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Kaiser Permanente - Denver

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Kaiser Permanente - Lafayette

Lafayette, Colorado, United States

Site Status

Littleton Adventist Hospital

Littleton, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Parker Adventist Hospital

Parker, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

WellStar Cobb Hospital

Austell, Georgia, United States

Site Status

John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status