Zevalin-beam for Aggressive Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491491
• Other study ID #: SHEBA-07-4466-AN-CTIL
• Status: Completed
• Phase: Phase 3
• Start date: June 2007
• Est. completion date: February 2015

Study information

• Verified date: August 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• ibritumomab tiuxetan
0.4 mCi/kg

Procedure:
• BEAM chemotherapy and autologous stem-cell transplantation

Locations

Country	Name	City	State
Germany	Georg-August Universität	Göttingen
Israel	Chaim Sheba Medical Center	Tel Hashomer
Netherlands	VU Medical Center	Amsterdam
United States	Northwestern University	Chicago	Illinois
United States	City of Hope National Medical Center	Duarte	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Sheba Medical Center	City of Hope Medical Center, University of Göttingen, VU University Medical Center

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	actuarial 2 year survival	2 years after transplantation
Secondary	Progression-free Survival	actuarial 2-year PFS	2 years after transplantation
Secondary	Clinical Response	complete response (CR) and partial response (PR) proportion at day 100,	100 days after transplantation
Secondary	Hematopoietic Recovery	time to hematopoietic recovery	100 days after transplantation
Secondary	Grade III Toxicity	incidence of infection, grade III-IV toxicities, treatment-related mortality	100 days after transplantation
Secondary	Secondary Malignancies	incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).	5 years after transplantation