Zevalin-beam for Aggressive Lymphoma

NCT00491491 | Completed Phase 3 Results

• 1 other identifier: SHEBA-07-4466-AN-CTIL
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 9

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

non-Hodgkin's lymphoma; autologous stem cell transplantation; radioimmunotherapy; zevalin

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  actuarial 2 year survival

  2 years after transplantation

Secondary Outcomes (5)

• Progression-free Survival

  2 years after transplantation

• Clinical Response

  100 days after transplantation

• Hematopoietic Recovery

  100 days after transplantation

• Grade III Toxicity

  100 days after transplantation

• Secondary Malignancies

  5 years after transplantation

Study Arms (2)

Z-BEAM

EXPERIMENTAL

ibritumomab tiuxetan (zevalin) BEAM

Drug: ibritumomab tiuxetan; Procedure: BEAM chemotherapy and autologous stem-cell transplantation

standard BEAM

ACTIVE COMPARATOR

standard BEAM chemotherapy

Procedure: BEAM chemotherapy and autologous stem-cell transplantation

Interventions

ibritumomab tiuxetan DRUG

0.4 mCi/kg

Also known as: zevalin

Z-BEAM

BEAM chemotherapy and autologous stem-cell transplantation PROCEDURE

Z-BEAM; standard BEAM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• City of Hope Medical Center: collaborator
• Amsterdam UMC, location VUmc: collaborator
• University of Göttingen: collaborator

Study Sites (9)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, United States

Location

Moffitt Cancer Center

Tampa, Florida, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Georg-August Universität

Göttingen, Germany

Location

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

VU Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr Avichai Shimoni
• Organization: Chaim Sheba Medical Center

ashimoni@sheba.health.gov.il

972 3 530 5303

Study Officials

• Avichai Shimoni, MD

  Chaim Sheba Medical Center, Tel Hashomer, Israel

  STUDY CHAIR

• Amrita Krishnan, MD

  City of Hope National Medical Center, Duarte, CA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Avichai Shimoni

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 31, 2020
• Results First Posted: August 31, 2020

Record last verified: 2020-08

Locations

NL (1); US (6); DE (1); IL (1)