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Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma

Primary Purpose

Lymphoma, Mantle-Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yttrium-ibritumomab (Zevalin)
Rituximab
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Mantle-Cell focused on measuring Relapsed/Refractory Mantle Cell Lymphoma, Yttrium-Ibritumomab, Zevalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Histologically confirmed, relapsed or refractory mantle cell lymphoma requiring treatment. No anti-cancer therapy for three weeks (6 weeks if rituximab, nitrosurea, or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. An IRB-approved signed informed consent. Age greater or equal to 18 years. Expected survival greater than or equal to 3 months. Pre-study performance status of 0, 1, or 2 according to the World Health Organizations (WHO) criteria. Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count (segmented neutrophils = bands * total White Blood Count (WBC)) greater than or equal to 1,500/mm^3; Platelets greater than or equal to 1000,000/mm^3. Female patients who are not pregnant or lactating. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method). Patients previously on investigational Phase II anti-cancer drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed. Patients determined to have less than 25% bone marrow involvement with mantle cell lymphoma within six weeks of registration. Measurement to be determined by bilateral bone marrow biopsies. This criteria must be strictly met for adequate patient safety. Exclusion Criteria: Prior autologous or allogeneic bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue therapy. Prior radioimmunotherapy. Presence of Central Nervous System (CNS) lymphoma. Patients with HIV or AIDS-related lymphoma. Patients with pleural effusion. Patients with abnormal liver function: Total bilirubin greater than 2.0mg/dL Patients with abnormal renal function: serum creatinine greater than 2.0mg/dL Patients who have received prior external beam radiotherapy to greater than 25% of active bone (involved field or regional). Patients who have received Granulocyte colony-stimulating factor (G-CSF or GM-CSF) therapy within two weeks prior to treatment. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives. Major surgery, other than diagnostic surgery, within four weeks. Impaired bone marrow reserve as indicated by one or more of the following: a) History of failed stem cell collection. b) Platelet count less than 1000,000 cells/mm^3. c) Hypocellular bone marrow (less than 15% cellularity). d) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid). Presence of leukemic phase of disease defined as peripheral blood absolute lymphocyte count of greater than 5,000/microliters.

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yttrium-ibritumomab (Zevalin)

Arm Description

After Rituximab infusion (250 mg/m^2 intravenous) on Day 1, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.

Outcomes

Primary Outcome Measures

Number of Participants with Objective tumor response
Objective tumor response is defined as CR + CCR + PR, where CR = Complete Response, CCR = Clinical Complete Response and PR = partial response. All patients who receive any dose of Zevalin will be included in the calculation of response rate.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2002
Last Updated
October 31, 2011
Sponsor
M.D. Anderson Cancer Center
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00038623
Brief Title
Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Official Title
A Phase II Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed & Refractory Mantle Cell Lymphoma
Detailed Description
Mantle cell lymphoma cell express a protein called CD20. Ibritumomab tiuxetan is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium. The radioactivity will be delivered to the cancer cells by the antibody will help killing the mantle cell lymphoma cells. Before treatment starts, patients will have a physical exam, including blood and urine test. Patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow samples will be taken with a large needle. A cardiogram (EKG) will be performed before therapy and after 1 and 3 months of therapy. Patients in this study will receive one dose of rituximab in the vein over 6 to 8 hours on the first day of treatment. This will be followed by an infusion of antibody labeled with radioactive indium, which will allow imaging of the tumor sites and normal tissue site that will bind the antibody. Imaging will be performed twice in the nuclear medicine department of Day 1, and once on either Day 2 or 3. On day 8 (7 days after the first dose of rituximab), patients will receive a second dose of rituximab. This will immediately be followed by a dose of Ibritumomab tiuxetan given by vein over ten minutes. Patients will receive diphenhydramine (Benadryl) by vein and mouth and acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to prevent fever and chills. All treatments will be given in an outpatient setting. Blood test will be taken weekly during the first 3 months, the every 3 months for 1 year, and then every 6 months for 3 years. CT scans, x-rays, and bone marrow biopsies will be repeated if needed after 3 months of therapy and every 3 months for 1 years, then every 6 months for 3 years. If tumors do not shrink after 3 months of therapy or increase in size, patients will be offered a different treatment. This is an investigational study. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Mantle-Cell
Keywords
Relapsed/Refractory Mantle Cell Lymphoma, Yttrium-Ibritumomab, Zevalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yttrium-ibritumomab (Zevalin)
Arm Type
Experimental
Arm Description
After Rituximab infusion (250 mg/m^2 intravenous) on Day 1, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Intervention Type
Drug
Intervention Name(s)
Yttrium-ibritumomab (Zevalin)
Other Intervention Name(s)
90-Yttrium-ibritumomab, Zevalin, IDEC-Y2B8, Ibritumomab, Ibritumomab tiuxetan
Intervention Description
After Rituximab infusion, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
250 mg/m^2 in the vein over 6 to 8 hours on Day 1.
Primary Outcome Measure Information:
Title
Number of Participants with Objective tumor response
Description
Objective tumor response is defined as CR + CCR + PR, where CR = Complete Response, CCR = Clinical Complete Response and PR = partial response. All patients who receive any dose of Zevalin will be included in the calculation of response rate.
Time Frame
Followed for 4 years or until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, relapsed or refractory mantle cell lymphoma requiring treatment. No anti-cancer therapy for three weeks (6 weeks if rituximab, nitrosurea, or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. An IRB-approved signed informed consent. Age greater or equal to 18 years. Expected survival greater than or equal to 3 months. Pre-study performance status of 0, 1, or 2 according to the World Health Organizations (WHO) criteria. Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count (segmented neutrophils = bands * total White Blood Count (WBC)) greater than or equal to 1,500/mm^3; Platelets greater than or equal to 1000,000/mm^3. Female patients who are not pregnant or lactating. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method). Patients previously on investigational Phase II anti-cancer drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed. Patients determined to have less than 25% bone marrow involvement with mantle cell lymphoma within six weeks of registration. Measurement to be determined by bilateral bone marrow biopsies. This criteria must be strictly met for adequate patient safety. Exclusion Criteria: Prior autologous or allogeneic bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue therapy. Prior radioimmunotherapy. Presence of Central Nervous System (CNS) lymphoma. Patients with HIV or AIDS-related lymphoma. Patients with pleural effusion. Patients with abnormal liver function: Total bilirubin greater than 2.0mg/dL Patients with abnormal renal function: serum creatinine greater than 2.0mg/dL Patients who have received prior external beam radiotherapy to greater than 25% of active bone (involved field or regional). Patients who have received Granulocyte colony-stimulating factor (G-CSF or GM-CSF) therapy within two weeks prior to treatment. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives. Major surgery, other than diagnostic surgery, within four weeks. Impaired bone marrow reserve as indicated by one or more of the following: a) History of failed stem cell collection. b) Platelet count less than 1000,000 cells/mm^3. c) Hypocellular bone marrow (less than 15% cellularity). d) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid). Presence of leukemic phase of disease defined as peripheral blood absolute lymphocyte count of greater than 5,000/microliters.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

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Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma

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