Recruitment

Recruitment Status
Active, not recruiting

Inclusion Criteria

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
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional upper limit of normal
...
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
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional upper limit of normal
Total bilirubin within institutional normal limits
Patients who are considered rituximab refractory (defined as progression within 6 months of their last rituximab-containing regimen)
Creatinine within normal institutional limits OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal
Karnofsky performance status of ≥ 60%
Ability to understand and the willingness to sign a written informed consent document
Life expectancy of greater than 3 months
Patients fit for non-myeloablative transplantation or best treatment that have an available matched (9/10 or better) related or unrelated donor
Blood counts no restrictions
Patients who had anything less than a CR (PR, SD or progressive disease) to their last salvage regimen

Exclusion Criteria

Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Human immunodeficiency virus (HIV)-positive patients
Esophageal varices
...
Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Human immunodeficiency virus (HIV)-positive patients
Esophageal varices
Cirrhosis with evidence of portal hypertension or bridging fibrosis
Pregnant women are excluded from this study
Patients may not be receiving any other investigational agents
Fulminant liver failure
Failure to obtain insurance/payment authorization for Zevalin, unless the subject agrees to cover the cost
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
Alcoholic hepatitis
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
A history of bleeding esophageal varices
Symptomatic biliary disease
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%
Ascites related to portal hypertension
Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
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
Hepatic encephalopathy
Chronic viral hepatitis with total serum bilirubin > 3 mg/dL

Summary

Conditions
  • Refractory Non Hodgkin Lymphoma
  • Relapsed Non Hodgkin Lymphoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 75 years
Gender
Both males and females

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 assess the time to engraftment/chimerism. II. To assess the rate of acute and chronic graft-versus-host disease (G...

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 assess the time to engraftment/chimerism. II. To assess the rate of acute and chronic graft-versus-host disease (GVHD). III. To assess toxicity. IV. To determine the overall survival. V. To investigate immune functional and phenotypic analysis. VI. To measure two year event free survival (EFS). OUTLINE: CONDITIONING REGIMEN: Patients receive rituximab intravenously (IV) on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine orally (PO) twice daily (BID) or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28. After completion of study treatment, patients are followed up periodically.

Inclusion Criteria

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
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional upper limit of normal
...
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
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional upper limit of normal
Total bilirubin within institutional normal limits
Patients who are considered rituximab refractory (defined as progression within 6 months of their last rituximab-containing regimen)
Creatinine within normal institutional limits OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal
Karnofsky performance status of ≥ 60%
Ability to understand and the willingness to sign a written informed consent document
Life expectancy of greater than 3 months
Patients fit for non-myeloablative transplantation or best treatment that have an available matched (9/10 or better) related or unrelated donor
Blood counts no restrictions
Patients who had anything less than a CR (PR, SD or progressive disease) to their last salvage regimen

Exclusion Criteria

Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Human immunodeficiency virus (HIV)-positive patients
Esophageal varices
...
Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Human immunodeficiency virus (HIV)-positive patients
Esophageal varices
Cirrhosis with evidence of portal hypertension or bridging fibrosis
Pregnant women are excluded from this study
Patients may not be receiving any other investigational agents
Fulminant liver failure
Failure to obtain insurance/payment authorization for Zevalin, unless the subject agrees to cover the cost
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
Alcoholic hepatitis
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
A history of bleeding esophageal varices
Symptomatic biliary disease
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%
Ascites related to portal hypertension
Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
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
Hepatic encephalopathy
Chronic viral hepatitis with total serum bilirubin > 3 mg/dL

Tracking Information

NCT #
NCT01811368
Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
  • Principal Investigator: Joseph Tuscano UC Davis Comprehensive Cancer Center
  • Joseph Tuscano UC Davis Comprehensive Cancer Center
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