Phase 2
Completed N=111
Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma · Marginal Zone Lymphoma · Diffuse Large B-Cell Lymphoma · Follicular Lymphoma
Source: ClinicalTrials.gov NCT00073918 ↗
Enrolled (actual)
111
Serious AEs
8.4%
Results posted
Jan 2017
Primary outcomePrimary: Progression-free Survival — 56 percentage of participants
Summary
This phase II trial is studying how well giving iodine I 131 tositumomab together with etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplant may kill more cancer cells
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
56 | — |
| SECONDARY 5 Year Overall Survival |
72 | — |
| SECONDARY Response Rate |
41.4 | — |
| SECONDARY Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0 |
9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically confirmed diagnosis of lymphoma expressing the cluster of differentiation (CD)20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) in accordance with current transplant standard of care for these patients
- Note: Patients with clinically non-transformed follicular lymphomas do not require repeat biopsies for immunophenotyping since these tumors are uniformly reactive with the tositumomab antibody
- Patients must have tumor burdens 2 standard deviations of the mean spleen volume to body weight ratio (mean = 3.84 cc/kg, SD = 1.53 cc/kg); thus, patients with > 6.9cc/kg will be defined as having splenomegaly; patients with splenomegaly that is thought to be due to G CSF/GM-CSF effect and not due to lymphomatous involvement of the spleen can been deemed eligible with the approval of an investigator
- Patients must have normal renal function (creatinine [Cr] 60 days and must be free of major infection
Exclusion Criteria
- Circulating anti-mouse antibody (HAMA)
- Systemic anti-lymphoma therapy given within 30 days prior to anticipated treatment date
- Inability to understand or give an informed consent
- Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or over 25% of red marrow)
- Central nervous system lymphoma
- Other serious medical conditions considered to represent contraindications to autologous stem cell transplant (ASCT) (e.g., active coronary artery disease, pulmonary dysfunction [forced expiratory volume in 1 second (FEV1) = 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSC are to be used
- Southwest Oncology Group (SWOG) performance status >= 2.0
- Unable to perform self-care during radiation isolation
- Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma/well differentiated lymphocytic lymphoma (ineligible because these tumors express very low surface densities of CD20)
Data sourced from ClinicalTrials.gov (NCT00073918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.