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Phase 2 N=25 Treatment

Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Lymphoma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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