Yükleniyor... / Loading...
This study evaluates a radioactively-labeled antibody (Yttrium Y 90 Ibritumomab Tiuxetan), chemotherapy (Etoposide, Cyclophosphamide), and an autologous stem cell transplant (using the patient's own stem cells) in patients with low- or intermediate-grade non-Hodgkin lymphoma (NHL). It included patients with biopsy-proven NHL. It was a Phase 1/Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS:
* Biopsy proven diagnosis of low- or intermediate-grade\* non-Hodgkin lymphoma (NHL) including any of the following:
* Follicular small cleaved
* Follicular mixed
* Follicular large cell
* Diffuse small cleaved
* Diffuse mixed
* Diffuse large cell
* Immunoblastic (working formulation B, C, D, E, F, G and H) NOTE: \*A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low-", "intermediate-", or "high-" grade lymphoma. However, this protocol uses the former terminology.
* Mantle cell and transformed low-grade lymphomas allowed
* Demonstrated monoclonal CD20-positive B-cell population in lymph nodes and/or bone marrow
* Favorable biodistribution on imaging dose
* Patient either relapsed after achieving a complete (CR) or partial response (PR) to prior therapy, never responded to prior therapy, or has poor-risk disease
* Sensitivity of disease based on 1 of the following:
* Induction failure: patients who did not achieve a CR or PR from induction chemotherapy
* Resistant relapse: patients who did not achieve a CR or PR from the most recent standard salvage chemotherapy
* Sensitive relapse: patients who did achieve a CR or PR from the most recent standard salvage chemotherapy
* Poor-risk disease defined as any of the following:
* Age-adjusted International Prognostic Index (IPI) High- (3 risk factors) or High-Intermediate (2 risk factors) based on the following risk factors:
* Stage III-IV disease
* Elevated serum lactate dehydrogenase level
* ECOG performance status 2-4
* Patients with aggressive NHL including mantle cell lymphoma and who required 2 different induction chemotherapy regimens to achieve a CR/PR
* Patients with B-cell NHL and who failed to achieve a CR after adequate induction chemotherapy regimen(s)
* Patients must have bone marrow aspiration and biopsy within 42 days before salvage chemotherapy or stem cell collection which show ≤ 10% lymphomatous involvement of total cellularity
* Normal cytogenetic study on bone marrow (prior to salvage chemotherapy or stem cell collection)
* Cytogenetic study on peripheral blood is acceptable if bone marrow biopsy has already been done and shows no sign of myelodysplastic syndrome (MDS) or lymphoma and a repeat bone marrow is deemed unnecessary by attending physician
* No active or prior history of CNS diseases
* No human anti-mouse antibody (HAMA) or human anti-chimeric antibody
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 or Karnofsky PS 80-100%
* Platelet count normal
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min
* FEV\_1 \> 65% of predicted or DLCO ≥ 50% of predicted
* LVEF \> 50% by ECHO or MUGA scan
* Bilirubin ≤ 1.5 times normal
* SGOT or SGPT ≤ 2 times normal
* HIV antibody-negative
* No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma, or other cancer from which the patient has been disease-free for at least five years
* No active evidence of hepatitis B or C infection
* No hepatitis B surface antigen positivity
* No history of alcohol abuse
* Body weight ≤ 250 pounds
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Patients who have received involved field external beam therapy to area excluding lung, heart, liver and kidney are allowed, but will be evaluated on a case-by-case basis
* Patients must have recovered from last therapy and should be at least four weeks from prior radiation or chemotherapy
* No prior radioimmunotherapy
* No prior bone marrow transplantation