Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
A Phase II Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
1 other identifier
interventional
35
1 country
1
Brief Summary
Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed \& Refractory Mantle Cell Lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 3, 2002
CompletedFirst Posted
Study publicly available on registry
June 4, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedNovember 2, 2011
October 1, 2011
5.7 years
June 3, 2002
October 31, 2011
Conditions
Keywords
Outcome Measures
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.
Followed for 4 years or until disease progression
Study Arms (1)
Yttrium-ibritumomab (Zevalin)
EXPERIMENTALAfter 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.
Interventions
After Rituximab infusion, 111\^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
250 mg/m\^2 in the vein over 6 to 8 hours on Day 1.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Biogencollaborator
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anas Younes, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2002
First Posted
June 4, 2002
Study Start
April 1, 2002
Primary Completion
December 1, 2007
Study Completion
February 1, 2010
Last Updated
November 2, 2011
Record last verified: 2011-10