Zevalin-beam for Aggressive Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Sheba Medical Center
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
ClinicalTrials.gov Identifier:
NCT00491491
First received: June 25, 2007
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • overall survival [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: No ]
  • clinical response [ Time Frame: 100 days after transplantation ] [ Designated as safety issue: No ]
    complete response (CR) and partial response (PR) proportion at day 100,

  • hematopoietic recovery [ Time Frame: 100 days after transplantation ] [ Designated as safety issue: No ]
    time to hematopoietic recovery

  • toxicity [ Time Frame: 100 days after transplantation ] [ Designated as safety issue: Yes ]
    incidence of infection, grade III-IV toxicities, treatment-related mortality

  • secondary malignancies [ Time Frame: 5 years after transplantation ] [ Designated as safety issue: Yes ]
    incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).


Estimated Enrollment: 158
Study Start Date: June 2007
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491491

Contacts
Contact: Avichai Shimoni, MD 972 3 530 5830 ashimoni@sheba.health.gov.il

Locations
United States, Arizona
Mayo Clinic Arizona Not yet recruiting
Scottsdale, Arizona, United States
Contact: Craig Reeder, MD    480-301-8335    Reeder.Craig@mayo.edu   
Principal Investigator: Craig Reeder, MD         
United States, California
City of Hope National Medical Center Not yet recruiting
Duarte, California, United States, 91010-3000
Contact: Amrita Krishnan, MD    800-826-4673 ext 6553    akrishnan@coh.org   
Principal Investigator: Amrita Krishnan, MD         
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States
Contact: Maria Delioukina, MD    310-248-8144    Maria.Delioukina@cshs.org   
Principal Investigator: Maria Delioukina, MD         
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States
Contact: Marcie Tomblyn, MD       marcie.tomblyn@moffitt.org   
Principal Investigator: Marcie Tomblyn, MD         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States
Contact: Jane Winter, MD    312-695-4538    Jwinter@nmff.org   
Principal Investigator: Jane Winter, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: David Inwards, MD       Inwards.davis@mayo.edu   
Principal Investigator: David Inwards, MD         
Germany
Georg-August Universität Not yet recruiting
Göttingen, Germany
Contact: Justin Hasenkamp, MD, PhD    ++49-551 39 5669    j.hasenkamp@med.uni-goettingen.de   
Principal Investigator: Justin Hasenkamp, MD, PhD         
Israel
Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Avichai Shimoni, MD    972 3 530 5303    ashimoni@sheba.health.gov.il   
Principal Investigator: Avichai Shimoni, MD         
Netherlands
VU Medical Center Not yet recruiting
Amsterdam, Netherlands
Contact: Otto Visser, MD    ++31-(0)20-4442604    O.Visser@vumc.nl   
Principal Investigator: Otto Visser, MD         
Sponsors and Collaborators
Sheba Medical Center
City of Hope Medical Center
VU University Medical Center
University of Göttingen
Investigators
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

No publications provided

Responsible Party: Dr. Avichai Shimoni MD, Dr. Avichai Shimoni, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00491491     History of Changes
Other Study ID Numbers: SHEBA-07-4466-AN-CTIL
Study First Received: June 25, 2007
Last Updated: October 28, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
non-Hodgkin's lymphoma
autologous stem cell transplantation
radioimmunotherapy
zevalin

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014