Trial record 1 of 1 for:
NCT00491491
Zevalin-beam for Aggressive Lymphoma
This study is currently recruiting participants.
Verified December 2012 by Sheba Medical Center
Sponsor:
Sheba Medical Center
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: December 5, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
- Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
- Age ≥ 18 years and age ≤ 70
- Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
- All prior chemotherapy completed at least three weeks before study treatment.
- Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
- Negative HIV antibody.
Exclusion Criteria:
- 1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
- Two or more relapses after initial response to induction chemotherapy.
- 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.
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
- Creatinine > 2.0 mg/dl.
- ECOG Performance status > 2.
- Uncontrolled infection.
- Pregnancy or lactation.
- Abnormal lung diffusion capacity (DLCO < 40% predicted).
- Severe cardiovascular disease; New York Heart Association (NYHA) Functional Classification ≥2.
- Active CNS disease involvement.
- 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.
- Pleural effusion or ascites > 1 liter.
- Known hypersensitivity to rituximab.
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
- Prior radioimmunotherapy.
- Prior autologous or allogeneic HSCT.
- Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
- 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.
- Patients who have received >500cGy radiation to the kidneys will be excluded from the study.
Contacts and Locations
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: | December 5, 2012 |
| 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, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013