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Zevalin-beam for Aggressive Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491491
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : December 2, 2015
City of Hope Medical Center
VU University Medical Center
University of Göttingen
Information provided by (Responsible Party):
Dr. Avichai Shimoni MD, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE June 25, 2007
First Posted Date  ICMJE June 26, 2007
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE June 2007
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2012)
overall survival [ Time Frame: 2 years after transplantation ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2007)
disease free survival [ Time Frame: 2 years after treatment ]
Change History Complete list of historical versions of study NCT00491491 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
  • progression-free survival [ Time Frame: 2 years after transplantation ]
  • clinical response [ Time Frame: 100 days after transplantation ]
    complete response (CR) and partial response (PR) proportion at day 100,
  • hematopoietic recovery [ Time Frame: 100 days after transplantation ]
    time to hematopoietic recovery
  • toxicity [ Time Frame: 100 days after transplantation ]
    incidence of infection, grade III-IV toxicities, treatment-related mortality
  • secondary malignancies [ Time Frame: 5 years after transplantation ]
    incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2007)
treatment related mortality [ Time Frame: 100 days after transplantation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Zevalin-beam for Aggressive Lymphoma
Official Title  ICMJE SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed Diffuse Large B-cell Lymphoma
Brief Summary The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin's Lymphoma
Intervention  ICMJE
  • Drug: ibritumomab tiuxetan
    0.4 mCi/kg
    Other Name: zevalin
  • Procedure: BEAM chemotherapy and autologous stem-cell transplantation
Study Arms  ICMJE
  • Experimental: Z-BEAM
    ibritumomab tiuxetan (zevalin) BEAM
    • Drug: ibritumomab tiuxetan
    • Procedure: BEAM chemotherapy and autologous stem-cell transplantation
  • Active Comparator: standard BEAM
    standard BEAM chemotherapy
    Intervention: Procedure: BEAM chemotherapy and autologous stem-cell transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2007)
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Age ≥ 18 years and age ≤ 70
  5. Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
  6. Patients must sign written informed consent.
  7. Adequate birth control in fertile patients.
  8. All prior chemotherapy completed at least three weeks before study treatment.
  9. Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
  10. Negative HIV antibody.

Exclusion Criteria:

  1. 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 all other selection criteria.
  4. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
  5. Creatinine > 2.0 mg/dl.
  6. ECOG Performance status > 2.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Israel,   Netherlands,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00491491
Other Study ID Numbers  ICMJE SHEBA-07-4466-AN-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Avichai Shimoni MD, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE
  • City of Hope Medical Center
  • VU University Medical Center
  • University of Göttingen
Investigators  ICMJE
Study Chair: Avichai Shimoni, MD Chaim Sheba Medical Center, Tel Hashomer, Israel
Study Chair: Amrita Krishnan, MD City of Hope National Medical Center, Duarte, CA
PRS Account Sheba Medical Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP