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CompletedNCT00038623Updated Nov 2, 2011

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

A Phase 2 interventional study of Yttrium-ibritumomab (Zevalin) and Rituximab in Lymphoma, Mantle-Cell, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-02.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Lymphoma, Mantle-Cell

Keywords

  • Relapsed/Refractory Mantle Cell Lymphoma
  • Yttrium-Ibritumomab
  • Zevalin
03

In context

Lymphoma

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

This study's enrollment of 35 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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) · Drug: Rituximab

Interventions

  • DrugYttrium-ibritumomab (Zevalin)

    After Rituximab infusion, 111\^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.

    Also known as: 90-Yttrium-ibritumomab, Zevalin, IDEC-Y2B8, Ibritumomab, Ibritumomab tiuxetan

  • DrugRituximab

    250 mg/m\^2 in the vein over 6 to 8 hours on Day 1.

    Also known as: Rituxan

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Followed for 4 years or until disease progression

07

Study locations

1 site
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00038623
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
Biogen
Responsible party
Sponsor
First posted
Jun 4, 2002
Start date
Apr 2002
Primary completion
Dec 2007
Completion
Feb 2010
Last update
Nov 2, 2011

Study contacts

Anas Younes, MD
principal investigator · UT MD Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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