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Monoclonal Antibodies
Zevalin + Stem Cell Transplant for Non-Hodgkin Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Joseph Tuscano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether giving ibritumomab tiuxetan before a donor peripheral blood stem cell transplant helps treat patients with relapsed or refractory non-Hodgkin lymphoma.
Eligible Conditions
- Non-Hodgkin's Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response conversion rate (PD/SD to PR and CR)
Secondary study objectives
EFS
Overall survival
Time to engraftment/chimerism
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ibritumomab tiuxetan, allogeneic PBSCT)Experimental Treatment8 Interventions
CONDITIONING REGIMEN: Patients receive rituximab IV on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive cyclosporine PO BID or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330
anti-thymocyte globulin
2005
Completed Phase 3
~1000
ibritumomab tiuxetan
2007
Completed Phase 3
~80
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
cyclosporine
2000
Completed Phase 3
~1290
mycophenolate mofetil
2000
Completed Phase 3
~1740
rituximab
2000
Completed Phase 3
~2760
Find a Location
Who is running the clinical trial?
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
162 Total Patients Enrolled
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an ongoing infection that hasn't gotten better despite treatment for more than a month.You have symptoms of heart disease or heart failure that are not under control. If your doctor has measured your heart's pumping ability and it is less than 30%, you will be excluded.You are expected to live for at least 3 more months.You have active brain metastases or other neurological disorders or a history of seizures. These conditions may affect your prognosis and make you ineligible for this clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibritumomab tiuxetan, allogeneic PBSCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.