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Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma


Phase 2
18 Years
70 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma


Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's
lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that
targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and
survival rates in a safe and reliable manner.


Inclusion Criteria:



1. Age >=18 to <=70 years

2. Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or
transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma,
Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the
WHO and:

- Expressing the CD 20 antigen

- ECOG performance 0-2

- Written informed consent

3. Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.

Exclusion Criteria:

1. Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)

2. Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)

3. Cardiac ejection fraction <40%

4. Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60%
predicted) or receiving continuous oxygen

5. A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or
anaphylactic proteins to any component of the Zevalin therapy.

6. Female patients who are pregnant or breast feeding, and adults of reproductive
potential who are not employing an effective method of birth control during study
treatment

7. Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung,
liver, kidney, spinal cord).

8. CNS lymphoma

9. Ongoing infection

10. Prior treatment with radioimmunotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Principal Investigator

Ahmed Galal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University Health Center, Royal Victoria Hospital

Authority:

Canada: Health Canada

Study ID:

BMA-05-017-ZEV

NCT ID:

NCT00438581

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Zevalin
  • Autologous one Marrow Transplant
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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