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Zevalin-beam for Aggressive Lymphoma

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ClinicalTrials.gov Identifier: NCT00491491
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Collaborators:
City of Hope Medical Center
VU University Medical Center
University of Göttingen
Information provided by (Responsible Party):
Dr. Avichai Shimoni MD, Sheba Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: ibritumomab tiuxetan Procedure: BEAM chemotherapy and autologous stem-cell transplantation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Z-BEAM
ibritumomab tiuxetan (zevalin) BEAM
 Drug: ibritumomab tiuxetan
0.4 mCi/kg
Other Name: zevalin

Procedure: BEAM chemotherapy and autologous stem-cell transplantation
Active Comparator: standard BEAM
standard BEAM chemotherapy
 Procedure: BEAM chemotherapy and autologous stem-cell transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years after transplantation ]
    actuarial 2 year survival


Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 2 years after transplantation ]
    actuarial 2-year PFS

  2. Clinical Response [ Time Frame: 100 days after transplantation ]
    complete response (CR) and partial response (PR) proportion at day 100,

  3. Hematopoietic Recovery [ Time Frame: 100 days after transplantation ]
    time to hematopoietic recovery

  4. Grade III Toxicity [ Time Frame: 100 days after transplantation ]
    incidence of infection, grade III-IV toxicities, treatment-related mortality

  5. Secondary Malignancies [ Time Frame: 5 years after transplantation ]
    incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491491


Locations
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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
Cedars Sinai Medical Center
Los Angeles, California, United States
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Germany
Georg-August Universität
Göttingen, Germany
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel
Netherlands
VU Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Sheba Medical Center
City of Hope Medical Center
VU University Medical Center
University of Göttingen
Investigators
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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
More Information
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Responsible Party: Dr. Avichai Shimoni MD, Dr. Avichai Shimoni, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00491491    
Other Study ID Numbers: SHEBA-07-4466-AN-CTIL
First Posted: June 26, 2007    Key Record Dates
Results First Posted: August 31, 2020
Last Update Posted: August 31, 2020
Last Verified: August 2020
Keywords provided by Dr. Avichai Shimoni MD, Sheba Medical Center:
non-Hodgkin's lymphoma
autologous stem cell transplantation
radioimmunotherapy
zevalin
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases