Recruiting
Phase 1
Phase 2

Zevalin with Transplantation

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT00807196

Conditions

Non-Hodgkins Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Rituximab

90Y ibritumomab tiuxetan (Zevalin)

Cyclophosphamide

Fludarabine

Non myeloablative allogeneic stem cell transplantation

Study Details

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.

Conditions

Non-Hodgkins Lymphoma

Study ID

NCT00807196

Start date

Sep, 2008

Status verified date

Dec, 2008

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: T

Interventions

Rituximab

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

90Y ibritumomab tiuxetan (Zevalin)

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

Cyclophosphamide

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

Fludarabine

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

Non myeloablative allogeneic stem cell transplantation

Blood stem cell infusion on day 0

Primary outcome measure

  • Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Locations

Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H2V 1W7

Contacts

Principal Investigator:

Thomas Kiss, M.D.

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Dec 11, 2008

Last verified

Dec, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2008-12-11.