CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
cyclophosphamide +4 moredrug
Likely dose
Radioiodinated tositumomab (I-131 tositumomab) IV; etoposide IV; cyclophosphamide IV; followed by ASCTAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed CD20+ lymphoma; must have failed ≥1 prior standard systemic therapy, except mantle cell lymphoma patients may enroll in first complete remission per transplant standards
  • ✓Tumor burden <500cc by CT or MRI volumetric measurement
  • ✓No splenomegaly (defined as spleen volume >6.9cc/kg)
  • ✓Autologous hematopoietic stem cells (2 x 10^6 CD34+ cells/kg) must be harvested and cryopreserved
Key exclusion· 8
  • ✕Circulating anti-mouse antibody (HAMA) positive
  • ✕Systemic anti-lymphoma therapy within 30 days of anticipated treatment
  • ✕Prior radiation >20 Gy to critical organs or >25% of red marrow
  • ✕CNS lymphoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00073918
NCT00073918Phase 2Completed
CompareCT.gov

A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma

Fred Hutchinson Cancer Center·interventional·Posted Dec 11, 2003·Updated Aug 18, 2017

In Brief

A Phase 2 clinical trial evaluating cyclophosphamide, etoposide, and 3 other interventions for Anaplastic Large Cell Lymphoma and 16 related conditions. Completed, enrolled 111 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaplastic Large Cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2003
Enrollment StartFeb 1, 1999
Primary CompletionOct 2, 2011
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 22.6 years ago

Interventions

cyclophosphamidedrug

Given IV

etoposidedrug

Given IV

iodine I 131 tositumomabradiation

Given IV

quality-of-life assessmentprocedure

Ancillary study

peripheral blood stem cell transplantationprocedure

Undergo ASCT given via central catheter