COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038623
Recruitment Status : Completed
First Posted : June 4, 2002
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed & Refractory Mantle Cell Lymphoma

Condition or disease Intervention/treatment Phase
Lymphoma, Mantle-Cell Drug: Yttrium-ibritumomab (Zevalin) Drug: Rituximab Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Study Start Date : April 2002
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Yttrium-ibritumomab (Zevalin)
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.
Drug: Yttrium-ibritumomab (Zevalin)
After Rituximab infusion, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Other Names:
  • 90-Yttrium-ibritumomab
  • Zevalin
  • IDEC-Y2B8
  • Ibritumomab
  • Ibritumomab tiuxetan

Drug: Rituximab
250 mg/m^2 in the vein over 6 to 8 hours on Day 1.
Other Name: Rituxan

Primary Outcome Measures :
  1. Number of Participants with Objective tumor response [ Time Frame: Followed for 4 years or until disease progression ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Histologically confirmed, relapsed or refractory mantle cell lymphoma requiring treatment.
  2. 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.
  3. An IRB-approved signed informed consent.
  4. Age greater or equal to 18 years.
  5. Expected survival greater than or equal to 3 months.
  6. Pre-study performance status of 0, 1, or 2 according to the World Health Organizations (WHO) criteria.
  7. 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.
  8. Female patients who are not pregnant or lactating.
  9. 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).
  10. 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.
  11. 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:

  1. Prior autologous or allogeneic bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue therapy.
  2. Prior radioimmunotherapy.
  3. Presence of Central Nervous System (CNS) lymphoma.
  4. Patients with HIV or AIDS-related lymphoma.
  5. Patients with pleural effusion.
  6. Patients with abnormal liver function: Total bilirubin greater than 2.0mg/dL
  7. Patients with abnormal renal function: serum creatinine greater than 2.0mg/dL
  8. Patients who have received prior external beam radiotherapy to greater than 25% of active bone (involved field or regional).
  9. Patients who have received Granulocyte colony-stimulating factor (G-CSF or GM-CSF) therapy within two weeks prior to treatment.
  10. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives.
  11. Major surgery, other than diagnostic surgery, within four weeks.
  12. 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).
  13. Presence of leukemic phase of disease defined as peripheral blood absolute lymphocyte count of greater than 5,000/microliters.

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 identifier (NCT number): NCT00038623

Layout table for location information
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Layout table for investigator information
Principal Investigator: Anas Younes, MD UT MD Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038623    
Other Study ID Numbers: ID01-541
First Posted: June 4, 2002    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: October 2011
Keywords provided by M.D. Anderson Cancer Center:
Relapsed/Refractory Mantle Cell Lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents