Phase 2
N=25
Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00073957 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Response Rate = Complete and Partial Response at 12 Weeks. — 5; 3; 2; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); cytarabine (Drug); liposomal cytarabine (Drug); yttrium Y 90 ibritumomab tiuxetan (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate = Complete and Partial Response at 12 Weeks. |
5; 3; 2; 15 | — |
| PRIMARY Best Response |
8; 1; 1; 15 | — |
| SECONDARY Event Free Survival |
2.5 | — |
Summary
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:
- B-cell diffuse large cell variant
- Immunoblastic
- Mediastinal (thymic) large cell
- T-cell/histiocyte-rich
- Anaplastic large B-cell
- Intravascular large B-cell
- Lymphomatoid granulomatosis
- Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
- Relapsed disease, defined as the following:
- Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
- 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node
- Progressive disease, defined as the following:
- 50% increase from nadir in the SPD of any previously identified abnormal node
- Appearance of any new lesion during or at the end of therapy
- CD20-positive disease by immunohistochemistry
- Bidimensionally measurable disease
- At least 1 lesion at least 2.0 cm by CT scan
- Less than 25% bone marrow involvement by lymphoma
- No transformed lymphoma from indolent to aggressive
- No HIV- or AIDS-related lymphoma
- No hypocellular bone marrow
- No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
- No CNS lymphoma
- Ineligible for myeloablative therapy OR refused transplantation
- Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Lymphocyte count no greater than 5, 000/mm^3 (for patients with small lymphocytic lymphoma)
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
Renal
- Creatinine no greater than 2.0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after study participation
- No concurrent serious nonmalignant disease or infection that would preclude study participation
- No human antimurine antibody reactivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior autologous bone marrow transplantation
- No prior peripheral blood stem cell rescue
- No prior failed stem cell collection
- Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- No prior radioimmunotherapy
- No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow
Surgery
- More than 4 weeks since prior major surgery (except diagnostic surgery)
Other
- Recovered from all prior therapy
- More than 4 weeks since prior therapy for lymphoma
- More than 8 weeks since prior phase II investigational drugs
- No other concurrent antineoplastic therapy
Data sourced from ClinicalTrials.gov (NCT00073957). 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.