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Phase III Stidy of Zevalin And BEAM Compared With BEAM Alone Prior to Autologous Hematopoietic Steem Cell Transpl. in Pts Relapse of Non-Hodgkins Lymphoma


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

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Trial Information

Phase III Stidy of Zevalin And BEAM Compared With BEAM Alone Prior to Autologous Hematopoietic Steem Cell Transpl. in Pts Relapse of Non-Hodgkins Lymphoma


Inclusion Criteria:



1. Patients with CD20 positive aggressive non-Hodgkin's lymphoma, either diffuse large
B-cell or transformed follicular lymphoma as confirmed by a pathological biopsy
report.

2. Patients who are candidates for stem-cell transplantation due to refractory disease
to first line chemotherapy or relapsing disease and comply with standard transplant
eligibility criteria.

3. Patients must have chemo-sensitive disease achieving at least partial response to
salvage chemotherapy.

4. Patients were given up to 2 lines of therapy, initial treatment and one salvage
treatment. Local radiation therapy for consolidation is not considered a line of
therapy.

5. Age less than physiologic 65 years.

6. Patients with an adequate autologous stem cell collection for transplantation (>2.5 x
106 CD34+ cells/kg). Backup collection is preferable but not obligatory.

7. Patients must sign written informed consent.

8. Adequate birth control in fertile patients.

9. All prior chemotherapy completed at least three weeks before study treatment

Exclusion Criteria:

1. Chemo-refractory disease or more than 2 prior therapies

2. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit

3. Creatinine > 2.0 mg/dl

4. ECOG-Performance status < 2

5. Uncontrolled infection

6. Pregnancy or lactation

7. Abnormal lung diffusion capacity (DLCO < 40% predicted)

8. Severe cardiovascular disease

9. Chemo-refractory disease as determined by less than partial response to salvage
chemotherapy.

10. active CNS disease involvement

11. Pleural effusion or ascites > 1 liter

12. Known hypersensitivity to rituximab

13. Psychiatric conditions/disease that impair the ability to give informed consent or to
adequately co-operate

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Arnon Nagler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology and Bone Marrow Transplantation

Authority:

Israel: Clalit Health Services

Study ID:

Sor451107ctil

NCT ID:

NCT00463463

Start Date:

April 2007

Completion Date:

Related Keywords:

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

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