Phase 2
Completed N=65
Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
Source: ClinicalTrials.gov NCT00058422 ↗Enrolled (actual)
65
Serious AEs
52.3%
Results posted
Nov 2020
Primary outcomePrimary: Overall Survival — 32; 33 Participants
Summary
RATIONALE: Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have B-cell lymphoma that has not been previously treated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
32; 33 | — |
| PRIMARY Progression-free Survival |
— | — |
| PRIMARY Event-free Survival |
— | — |
| PRIMARY Incidence of Adverse Experiences |
65 | — |
| SECONDARY Conversion Rate to Complete Remission |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell lymphoma, including any of the following subtypes:
- Centroblastic
- Immunoblastic
- T-cell/histiocyte-rich
- Lymphomatoid granulomatosis type
- Anaplastic large B-cell
- Plasmablastic
- Mediastinal
- Intravascular large B-cell lymphoma
- Previously untreated
- High-intermediate or high-risk disease, defined by an age-adjusted international prognostic index score of 2 or 3 (with 1 point each assigned for a ECOG greater than 1/Karnofsky less than 80%, lactate dehydrogenase greater than normal, and stage III or IV)
- Lymphomas with discordant histology and a diffuse large B-cell component are eligible
- Must have an initial diagnostic specimen that is CD20+
- At least Ann Arbor stage II disease
- No confinement of disease to an involved-field radiotherapy port (stage I or limited stage II disease)
- Bidimensionally measurable disease with at least 1 lymph node at least 2.0 cm by 2.0 cm by physical examination, CT scan, or positron-emission tomography
- Bone marrow cellularity greater than 15%
- No known brain or leptomeningeal metastases
- No primary effusion lymphomas
PATIENT CHARACTERISTICS:
Age
- 60 and over* NOTE: *Patients 60 to 65 years of age must be deemed ineligible for autologous stem cell transplantation
Performance status
- Karnofsky 50-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2.0 mg/dL (except for Gilbert's disease)
Renal
- Creatinine no greater than 1.5 mg/dL* OR
- Creatinine clearance greater than 50 mL/min* NOTE: *Patients not meeting either criterion but who have renal insufficiency directly related to lymphomatous involvement of the kidneys or renal collecting system are allowed
Cardiovascular
- Cardiac ejection fraction at least 50% by echocardiogram
- No acute myocardial infarction within the past 3 months
- No uncontrolled hypertension
- No New York Heart Association class III or IV congestive heart failure
- No unstable angina pectoris
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- B12 and folate greater than the lower limit of normal
- Transferrin saturation at least 15%
- Ferritin greater than 10 µg/L
- At least 6 weeks since prior RBC donation
- No active seizure disorder
- Prior seizure disorder allowed if free of antiseizure medication and evidence of seizure activity for the past 5 years
- No concurrent uncontrolled medical problems that would preclude administration of chemotherapy or radioimmunotherapy
- No other concurrent malignancy treated with chemotherapy or radiotherapy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior RBC transfusion
- No prior biologic therapy
- No other concurrent biologic therapy
Chemotherapy
- No prior chemotherapy (one course of R-CHOP allowed)
- No other concurrent standard or investigational chemotherapy
Endocrine therapy
- No more than 7 consecutive days of prior steroids (premedication allowed for prior intravenous contrast allergy)
- No other concurrent corticosteroids
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Data sourced from ClinicalTrials.gov (NCT00058422). 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. Informational only — not medical advice.