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

NCT00807196 | Unknown Phase 1 DMC

• 1 other identifier: ZEV0701
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Allogeneic Stem Cell Transplantation; Zevalin; Non-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (1)

• Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD

  one year

Secondary Outcomes (1)

• Overall response rate, overall and disease free survival

  360 days

Study Arms (1)

T

EXPERIMENTAL

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

Interventions

Rituximab DRUG

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

T

90Y ibritumomab tiuxetan (Zevalin) DRUG

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

T

Cyclophosphamide DRUG

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

T

Fludarabine DRUG

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

T

Non myeloablative allogeneic stem cell transplantation OTHER

Blood stem cell infusion on day 0

T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have/be
• 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.
• 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.
• 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
• Disease expressing the CD 20 antigen
• ECOG performance status 0-2
• Judged to be able to tolerate NST and Zevalin treatment based on institutional criteria.
• Signed written informed consent
• At least one fully HLA matched sibling without evident contraindications to the donation procedures and willing to sign consent for donation

You may not qualify if:

• Patients must not have/be
• Abnormal renal function (creatinine \> 1.5 x upper limit of normal (ULN)
• Abnormal hepatic function (bilirubin \> 2 x ULN, ALT/AST\>2x ULN)
• Cardiac ejection fraction \<40% and/or other significant cardiac compromise
• Severe defects in pulmonary function tests or receiving continuous oxygen
• Severe concurrent illness, such as symptomatic congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder or known HIV positive
• 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.
• History of prior allogeneic bone marrow transplant
• Evidence of active hepatitis B or C infection or positivity for hepatitis-B surface antigen
• 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)
• 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.
• CNS lymphoma
• Ongoing confirmed or suspected significant infection
• Prior treatment with radioimmunotherapy
• Other condition preventing participation in standard NST

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Bayer: collaborator

Study Sites (1)

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H2V 1W7, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; ibritumomab tiuxetan; Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Thomas Kiss, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Kiss, MD

CONTACT

514-252-3404; thomas.kiss@umomtreal.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 11, 2008

Record last verified: 2008-12

Locations

CA (1)