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

Phase 2
18 Years
Not Enrolling
Lymphoma, Mantle-Cell

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Trial Information

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

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.

Inclusion Criteria:

1. Histologically confirmed, relapsed or refractory mantle cell lymphoma requiring

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,

13. Presence of leukemic phase of disease defined as peripheral blood absolute lymphocyte
count of greater than 5,000/microliters.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Objective tumor response

Outcome 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.

Outcome Time Frame:

Followed for 4 years or until disease progression

Safety Issue:


Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2002

Completion Date:

February 2010

Related Keywords:

  • Lymphoma, Mantle-cell
  • Relapsed/Refractory Mantle Cell Lymphoma
  • Yttrium-Ibritumomab
  • Zevalin
  • Lymphoma
  • Lymphoma, Mantle-Cell



MD Anderson Cancer Center Houston, Texas  77030-4096