Phase 2
N=159
S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01359592 ↗Enrolled (actual)
159
Serious AEs
1.6%
Results posted
Jun 2021
Primary outcome: Primary: Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) — 87 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); prednisone (Drug); vincristine sulfate (Drug); R-CHOP regimen (Other); laboratory biomarker analysis (Other); fludeoxyglucose F 18 (Radiation); selective external radiation therapy (Radiation); yttrium Y 90 ibritumomab tiuxetan (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) |
87 | — |
| SECONDARY Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
89; 86 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
0; 0; 1; 0; 7; 0 | — |
| SECONDARY Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
89 | — |
| SECONDARY Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP |
112; 8; 0; 4; 1; 0 | — |
| SECONDARY Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival. |
— | — |
Summary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)
- Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group
- Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections
- Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible
- 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
Data sourced from ClinicalTrials.gov (NCT01359592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.