90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHL

NCT00186589 | Completed Phase 1

• 3 other identifiers: BMT13480109NCT00186589
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To test a new way to approach hematopoietic stem cell transplantation for Relapsed or Resistant Non-Hodgkin's Lymphoma.

Conditions

Lymphoma, Non-Hodgkin; Blood and Marrow Transplant (BMT)

Outcome Measures

Primary Outcomes (1)

• Complete Response

  completed

Interventions

90Y Ibritumomab tiuxetan DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven, recurrent or refractory, CD20+ B-cell NHL reviewed at SUMC.
• The definition of recurrent disease is: previous partial response (PR) or complete response (CR) to treatment followed by disease progression.
• The definition of refractory disease is: failure to achieve a PR or CR with or progression during primary induction therapy or subsequent salvage therapy. Patients who respond to treatment but progress within 60 days will also be considered refractory.
• CD20 expression may be determined by immunohistochemistry or flow cytometry. Whenever possible, confirmation of CD20+ status should be made on current, active disease.
• The definition of NHL will be made by SUMC pathologists using the World Health Organization Classification of Hematopoietic and Lymphoid Tissues (Appendix A).
• The diagnosis should be made by excisional biopsy whenever possible. Biopsy of refractory or recurrent disease is preferred but fine needle aspirate with supportive morphology and immunohistochemistry is acceptable. Paraffin tissue for tissue array studies will be sought for every patient.
• Age 18-70 years
• Age will be based on actual date of birth.
• Pediatric patients are not eligible for this study because they are transplanted in a separate dedicated unit with their own protocols.
• ECOG performance status 0-2 (Appendix B)
• Computerized tomography scans of the chest, abdomen and pelvis within 4 weeks of registration. Assessment of response to last chemotherapy prior to registration is mandatory.
• Response will be assessed according to the international consensus criteria (Cheson et al. J Clin Oncol 17:1244, 1999)
• Standard definitions of the chest, abdomen and pelvis will be used for radiographic studies.
• Gallium scan or PET scan determination of disease within 4 weeks of registration is highly recommended.
• Gallium or PET scans will be whole body scans

You may not qualify if:

• Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible.
• No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
• Patients known to be human immunodeficiency virus (HIV)-positive are ineligible because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. The antibody test for HIV must be performed within 42 days of registration.
• Patients requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure are not eligible.
• Pregnant or breast-feeding women are ineligible due to the known birth defects associated with the treatments used in this study.
• Patients with prior radiotherapy to \>25% of the active marrow are excluded.
• Patients treated previously with radioimmunotherapy are excluded.
• Patients with pleural effusion or ascites are excluded.
• Patients may have received prior rituximab but not within the past 4 weeks.
• Patients with prior autologous transplantation are ineligible.
• Patients with CNS disease are ineligible.
• Drop in diffusing capacity of \>25% from study entry.
• Drop in resting ejection fraction \> 20%.
• Failure to recover peripheral blood counts (ANC \> 1000/mm\^3 and platelet recovery count to \> 100,000/mm\^3 within 4 weeks after radioimmunotherapy.

Sponsors & Collaborators

• Stanford University: lead
• Biogen: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sandra Jeane Horning

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 6, 2012

Record last verified: 2010-10

Locations

US (1)