Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00438581

Acronym

Zevalin

Enrollment

Registered

2007-02-22

Start date

2007-03-31

Completion date

Unknown

Last updated

2007-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Keywords

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

Brief summary

This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.

Detailed description

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.

Interventions

DRUGYttrium 90 Ibritumomab Tiuxetan ( Zevalin )

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Survival Data, adverse events, molecular response	—

Countries

Canada

Contacts

Primary ContactAhmed Galal, MD

galala@muhchem.mcgill.ca514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026