Combination Chemotherapy or 90-Yttrium Ibritumomab Tiuxetan and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Relapsed Diffuse Large B-cell Non-Hodgkin Lymphoma

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-004205
    • Rochester, Minnesota: 15-004205
    NCT ID: NCT02366663
    Sponsor Protocol Number: 12338

About this study

This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination chemotherapy compared with combination chemotherapy alone before stem cell transplant in treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a period of improvement. Radioactive substances linked to monoclonal antibodies, such as 90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether 90-yttrium ibritumomab tiuxetan and BEAM before a stem cell transplant are more effective than BEAM alone in treating patients with diffuse large b-cell non-Hodgkin lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
  2. Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
  3. Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
  4. Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 10^6 CD34+ cells/kg).
  5. Patients must sign written informed consent.
  6. Adequate birth control in fertile patients.
  7. All prior chemotherapy completed at least three weeks before study treatment.
  8. Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
  9. Negative HIV antibody.

Exclusion Criteria:

  1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
  2. Two or more relapses after initial response to induction chemotherapy.
  3. High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent to all other selection criteria.
  4. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
  5. Creatinine > 2.0 mg/dl.
  6. KPS < 70.
  7. Uncontrolled infection.
  8. Pregnancy or lactation.
  9. Abnormal lung diffusion capacity (DLCO < 40% predicted).
  10. Severe cardiovascular disease; New York Heart Association (NYHA) Functional Classification ≥2.
  11. Active CNS disease involvement.
  12. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy > 5 years in relation to this prior malignance. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
  13. Pleural effusion or ascites > 1 liter.
  14. Known hypersensitivity to rituximab.
  15. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
  16. Prior radioimmunotherapy.
  17. Prior autologous or allogeneic HSCT.
  18. Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
  19. 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.
  20. Patients who have received >500cGy radiation to the kidneys will be excluded from the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

David Inwards, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

David Inwards, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions