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Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00807196
Recruitment Status : Unknown
Verified December 2008 by Maisonneuve-Rosemont Hospital.
Recruitment status was:  Recruiting
First Posted : December 11, 2008
Last Update Posted : December 11, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to investigate the ability to combine a radioactive medication directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem cell transplant.

Condition or disease Intervention/treatment Phase
Non-Hodgkins Lymphoma Drug: Rituximab Drug: 90Y ibritumomab tiuxetan (Zevalin) Drug: Cyclophosphamide Drug: Fludarabine Other: Non myeloablative allogeneic stem cell transplantation Phase 1 Phase 2

Detailed Description:
Despite initial high response rates of low grade Non Hodgkin lymphoma, progressive or refractory disease currently remains incurable. Being a radiosensitive tumor, we hypothesize that combining different modalities of treatment including targeted radioimmunotherapy (RIT), and a graft versus lymphoma effect related to an allogeneic non myeloablative stem cell transplant may increase response and survival rates in a safe manner in patients with persistent disease following initial treatment. In this study patients who are not eligible for a standard stem cell transplant approach because of relapsed or refractory disease and who have a related sibling donor are treated with RIT followed by an allogeneic non myeloablative blood stem cell transplant

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Non-Randomized Study of Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Indolent Non Hodgkin Lymphoma
Study Start Date : September 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: T Drug: Rituximab
250mg/m2 day -21 and day -14 of preparative regimen
Drug: 90Y ibritumomab tiuxetan (Zevalin)
0.4 mCi/kg IV on day -14 of preparative regimen
Drug: Cyclophosphamide
300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
Drug: Fludarabine
30mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
Other: Non myeloablative allogeneic stem cell transplantation
Blood stem cell infusion on day 0


Outcome Measures

Primary Outcome Measures :
  1. Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Overall response rate, overall and disease free survival [ Time Frame: 360 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have/be

  1. Age 18 to 65 years. Patients between age 66 and 69 may be enrolled if judged to be in excellent physical condition as per treating physician and study investigator and based on institutional practice.
  2. Diagnosis of Non-Hodgkin lymphoma, follicular, marginal zone, small lymphocytic lymphoma, mantle cell lymphoma or transformed from an indolent NHL to aggressive histology disease lymphoma as defined by the World Health Organization.
  3. Disease relapsed after, refractory or failing to achieve a PR after two or more cycles of intensive salvage chemotherapy (R-ESHAP or other) or disease relapsed after autologous stem cell transplantation. Poor partial response is defined as less than 50% reduction of tumor size. Salvage chemotherapy has to be administered after either 1st, 2nd or 3rd relapse
  4. Disease expressing the CD 20 antigen
  5. ECOG performance status 0-2
  6. Judged to be able to tolerate NST and Zevalin treatment based on institutional criteria.
  7. Signed written informed consent
  8. At least one fully HLA matched sibling without evident contraindications to the donation procedures and willing to sign consent for donation

Exclusion Criteria:

Patients must not have/be

  1. Abnormal renal function (creatinine > 1.5 x upper limit of normal (ULN)
  2. Abnormal hepatic function (bilirubin > 2 x ULN, ALT/AST>2x ULN)
  3. Cardiac ejection fraction <40% and/or other significant cardiac compromise
  4. Severe defects in pulmonary function tests or receiving continuous oxygen
  5. Severe concurrent illness, such as symptomatic congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder or known HIV positive
  6. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1) that may impact on patients life expectancy or any cancer curatively treated < 3 years prior to study entry.
  7. History of prior allogeneic bone marrow transplant
  8. Evidence of active hepatitis B or C infection or positivity for hepatitis-B surface antigen
  9. Known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy or a history or presence of human anti-mouse antibodies (HAMA)
  10. A female patient who is pregnant or breast feeding and an adult of reproductive potential who is not employing an effective method of birth control during the study.
  11. CNS lymphoma
  12. Ongoing confirmed or suspected significant infection
  13. Prior treatment with radioimmunotherapy
  14. Other condition preventing participation in standard NST
  15. No fully matched sibling donor
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807196


Contacts
Contact: Thomas Kiss, MD 514-252-3404 thomas.kiss@umomtreal.ca

Locations
Canada, Quebec
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H2V 1W7
Contact: Thomas Kiss, MD    (514)252-3404    thomas.kiss@umontreal.ca   
Contact: Dominique Beaupré, BSc nursing    (514)252-3400 ext 5605    dbeaupré.hmr@ssss.gouv.qc.ca   
Principal Investigator: Thomas Kiss, M.D.         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Bayer
Investigators
Principal Investigator: Thomas Kiss, MD Maisonneuve-Rosemont Hospital
More Information

Responsible Party: Carole Deschambault/executive director, Hopital Maisonneuve-Rosemont
ClinicalTrials.gov Identifier: NCT00807196     History of Changes
Other Study ID Numbers: ZEV0701
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008

Keywords provided by Maisonneuve-Rosemont Hospital:
Allogeneic Stem Cell Transplantation
Zevalin
Non-Hodgkins Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Fludarabine
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists