Know Cancer

or
forgot password

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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

2 years after transplantation

Safety Issue:

No

Principal Investigator

Avichai Shimoni, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chaim Sheba Medical Center, Tel Hashomer, Israel

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

SHEBA-07-4466-AN-CTIL

NCT ID:

NCT00491491

Start Date:

June 2007

Completion Date:

March 2017

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • non-Hodgkin's lymphoma
  • autologous stem cell transplantation
  • radioimmunotherapy
  • zevalin
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Mayo ClinicRochester, Minnesota  55905
City of Hope National Medical CenterLos Angeles, California  91010
Northwestern UniversityChicago, Illinois  60611
Moffitt Cancer CenterTampa, Florida  33612
Mayo Clinic ArizonaScottsdale, Arizona  85259