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Status unknownNCT00807196Updated Dec 11, 2008

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

A Phase 1/2 interventional study of Rituximab and 90Y ibritumomab tiuxetan (Zevalin) in Non-Hodgkins Lymphoma, sponsored by Maisonneuve-Rosemont Hospital. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-12-11.

Sponsored by Maisonneuve-Rosemont Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Non-Hodgkins Lymphoma

Keywords

  • Allogeneic Stem Cell Transplantation
  • Zevalin
  • Non-Hodgkins Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

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Lead sponsor

Maisonneuve-Rosemont Hospital is the lead sponsor of 70 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    T

    Drug: Rituximab · Drug: 90Y ibritumomab tiuxetan (Zevalin) · Drug: Cyclophosphamide · Drug: Fludarabine · Other: Non myeloablative allogeneic stem cell transplantation

Interventions

  • DrugRituximab

    250mg/m2 day -21 and day -14 of preparative regimen

  • Drug90Y ibritumomab tiuxetan (Zevalin)

    0.4 mCi/kg IV on day -14 of preparative regimen

  • DrugCyclophosphamide

    300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen

  • DrugFludarabine

    30mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen

  • OtherNon myeloablative allogeneic stem cell transplantation

    Blood stem cell infusion on day 0

06

What researchers measure

Primary outcomes

  1. Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD

    Time frame: one year

Secondary outcomes

  1. Overall response rate, overall and disease free survival

    Time frame: 360 days

07

Study locations

1 of 1 sites recruiting
  • Hopital Maisonneuve-Rosemont
    Montreal, Quebec H2V 1W7, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00807196
Lead sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Bayer
First posted
Dec 11, 2008
Start date
Sep 2008
Primary completion
Dec 2011 (estimated)
Completion
Dec 2012 (estimated)
Last update
Dec 11, 2008

Study contacts

Thomas Kiss, MD
Contact
thomas.kiss@umomtreal.ca
514-252-3404
Thomas Kiss, MD
principal investigator · Maisonneuve-Rosemont Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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