Status:
COMPLETED
Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II clinical trial studies how well yttrium Y 90 ibritumomab tiuxetan, rituximab, and high-dose chemotherapy followed by peripheral blood stem cell transplant in treating patients with relap...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the 2-year progression free survival. SECONDARY OBJECTIVES: II. To estimate the 2-year overall survival. III. To estimate the 2-year cumulative incidence of progr...
Eligibility Criteria
Inclusion
- All patients must have biopsy proven diagnosis of low- and intermediate-grade non-Hodgkin lymphoma (NHL) working formulation B, C,D, E, F, and G; including mantle cell lymphoma; patients with transformed lymphoma are also eligible
- Demonstrated monoclonal CD20 positive b-cell population in lymph nodes and/or bone marrow
- Patients must have relapsed after achieving a complete or partial response to prior therapy, have never responded to prior therapy or have poor risk disease
- Patients with prior bone marrow involvement must have bone marrow aspiration and biopsy within 60 days prior to stem cell collection which shows =\< 10% lymphomatous involvement of total cellularity; alternatively, patients with prior bone marrow involvement should have a normal bone marrow study which shows =\< 10% lymphomatous involvement within 28 days before salvage chemotherapy
- Normal renal function test with serum creatinine of \< upper limit of normal (ULN), and a creatinine clearance of \>= 60 ml/min (measured or calculated)
- Adequate pulmonary function as measured by forced expiratory volume in 1 second (FEV1) \> 60% of predicted measured, or a diffusion capacity of carbon monoxide (DLCO) \>= 50% of predicted measured
- Cardiac ejection fraction of \> 50% by echocardiogram or multi gated acquisition (MUGA) scan; the left ventricular ejection fraction (LVEF) from the prestudy echocardiogram (ECHO) or MUGA may be used for eligibility purposes, even if the prestudy stress test indicated a lower LVEF
- Adequate liver function tests with a bilirubin of =\< 1.5 x ULN and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) =\< 2 x ULN
- Negative human immunodeficiency virus antibody
- Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1; karnofsky performance status (KPS) \>= 80
- No active central nervous system (CNS) disease or prior history of CNS disease
- Patients must have recovered from last therapy and should be at least four weeks from prior radiation or systemic chemotherapy on the day of administration of Y2B8
- After the last systemic therapeutic chemotherapy (Cytoxan, administered only for stem cell mobilization is not considered therapeutic) and prior to initiation of high dose treatment, the patient should have a baseline computed tomography (CT) scan and positron emission tomography (PET) scan done; an fluorodeoxyglucose-computed tomography (FDG/CT) scan is sufficient, however, is clinically indicated, an additional diagnostic CT may be ordered; exception: if scans were done and were negative for disease just prior to priming chemotherapy (therapeutic or nontherapeutic) and subsequent stem cell harvest, they do not need to be repeated prior to initiation of high dose treatment
Exclusion
- Presence of human anti-Zevalin antibody (HAZA)
- Prior radioimmunotherapy
- Failure to collect adequate number of CD34+ cells \>= 3 x 10\^6/kg
- Abnormal cytogenetic study not related to the underlying lymphoma on the bone marrow aspirate sample prior to stem cell collection; if cytogenetics were not performed on the marrow aspirate prior to stem cell collection, cytogenetics on the peripheral blood may be performed
- Prior bone marrow transplantation
- Prior malignancy except for:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated noninvasive carcinoma
- Other cancer from which the patient has been disease-free for at least five years
- Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive
- Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume
- Patients who have received \> 500cGy radiation to the kidneys will be excluded from the study
- Patients who are pregnant or lactating
Key Trial Info
Start Date :
March 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2017
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00695409
Start Date
March 18 2008
End Date
March 27 2017
Last Update
July 6 2018
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000