Status:
UNKNOWN
Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
Lead Sponsor:
Joseph Tuscano
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Conditions:
Refractory Non Hodgkin Lymphoma
Relapsed Non Hodgkin Lymphoma
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma. Giving rituxim...
Detailed Description
PRIMARY OBJECTIVES: I. To measure the response conversion (progressive disease \[PD\]/stable disease \[SD\] to partial response \[PR\] and complete response \[CR\]). SECONDARY OBJECTIVES: I. To ass...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed relapsed cluster of differentiation (CD)20+ non-Hodgkin's lymphoma (NHL) (included in this category are follicular grade I, II, III, marginal zone, mantle cell, diffuse large B cell, small lymphocytic lymphoma) and CD20+ Hodgkin's disease for which standard curative therapy does not exist or is no longer effective
- Patients must have had at least one prior chemotherapeutic regimen; steroids alone and local radiation do not count as regimens; radiotherapy must have been completed at least 4 weeks prior to entry into the study; Rituxan alone does not count as a regimen; however, Bexxar or Zevalin (ibritumomab tiuxetan) do and patients must have completed radioimmunotherapy (RIT) \> 12 months prior to enrollment
- Karnofsky performance status of ≥ 60%
- Life expectancy of greater than 3 months
- Total bilirubin within institutional normal limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance \>= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Blood counts no restrictions
- Patients who had anything less than a CR (PR, SD or progressive disease) to their last salvage regimen
- Ability to understand and the willingness to sign a written informed consent document
- Patients fit for non-myeloablative transplantation or best treatment that have an available matched (9/10 or better) related or unrelated donor
- Patients who are considered rituximab refractory (defined as progression within 6 months of their last rituximab-containing regimen)
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, rituximab within three months (unless there is evidence of progression), or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded; this does not include the use of steroids which may continue until two days prior to enrollment
- Patients may not be receiving any other investigational agents
- Failure to obtain insurance/payment authorization for Zevalin, unless the subject agrees to cover the cost
- Patients with known active brain metastases, other neurological disorders/dysfunction or a history of seizure disorder, or other neurological dysfunction should be excluded from this clinical trial because of their poor prognosis
- Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
- Patients with symptomatic coronary artery disease, uncontrolled congestive heart failure; left ventricular ejection fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is \< 30%
- Patients requiring supplementary continuous oxygen; diffusion capacity of the lung of carbon monoxide (DLCO) is not required to be measured, however if it is measured, patient is excluded if DLCO \< 35%
- Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension
- Patients with any of the following liver function abnormalities will be excluded:
- Fulminant liver failure
- Cirrhosis with evidence of portal hypertension or bridging fibrosis
- Alcoholic hepatitis
- Esophageal varices
- A history of bleeding esophageal varices
- Hepatic encephalopathy
- Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
- Ascites related to portal hypertension
- Chronic viral hepatitis with total serum bilirubin \> 3 mg/dL
- Symptomatic biliary disease
- Pregnant women are excluded from this study
- Human immunodeficiency virus (HIV)-positive patients
Key Trial Info
Start Date :
March 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01811368
Start Date
March 12 2013
End Date
December 1 2023
Last Update
November 30 2022
Active Locations (1)
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1
University of California Davis
Sacramento, California, United States, 95817