Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2022
• Main ID: NCT01811368
• Date of registration: 11/03/2013
• Prospective Registration: Yes
• Primary sponsor: Joseph Tuscano
• Public title: Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
• Scientific title: Use of Zevalin to Enhance the Efficacy of Non-Myeloablative Allogeneic Transplantation in Patients With Relapsed or Refractory CD20+ Non-Hodgkin's Lymphoma
• Date of first enrolment: March 12, 2013
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01811368
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Joseph Tuscano
• Affiliation: UC Davis Comprehensive Cancer Center

Key inclusion & exclusion criteria

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

- 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 Criteria:

- 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



Age minimum: 19 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsed Non Hodgkin Lymphoma

Refractory Non Hodgkin Lymphoma

Intervention(s)

Biological: rituximab

Drug: cyclosporine

Biological: anti-thymocyte globulin

Biological: ibritumomab tiuxetan

Procedure: allogeneic hematopoietic stem cell transplantation

Procedure: peripheral blood stem cell transplantation

Radiation: total nodal irradiation

Drug: mycophenolate mofetil

Primary Outcome(s)

Response conversion rate (PD/SD to PR and CR) [Time Frame: Up to 60 days post-transplant]

Secondary Outcome(s)

Time to engraftment/chimerism [Time Frame: Up to 3 years]

Toxicities [Time Frame: Up to day 730]

Overall survival [Time Frame: Up to day 730]

EFS [Time Frame: 2 years]

Rate of acute GVHD [Time Frame: Up to day 730]

Rate of chronic GVHD [Time Frame: Up to day 730]

Secondary ID(s)

NCI-2012-02753

367905

UCDCC#233

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Spectrum Pharmaceuticals, Inc