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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

Study 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response conversion rate (PD/SD to PR and CR)

Secondary outcome measures

EFS

Overall survival

Rate of acute GVHD

+3 more

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

~1730

rituximab

2000

Completed Phase 3

~2760

Do I qualify?Apply below to find out

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

8,169 Total Patients Enrolled

Media Library

Ibritumomab Tiuxetan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01811368 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Treatment (ibritumomab tiuxetan, allogeneic PBSCT)

Non-Hodgkin's Lymphoma Clinical Trial 2023: Ibritumomab Tiuxetan Highlights & Side Effects. Trial Name: NCT01811368 — Phase 2

Ibritumomab Tiuxetan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01811368 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass individuals aged 40 and over?

"This study is open to people between the ages of 19 and 75. People below 18 have 447 trials available, whereas those over 65 can choose from 2100 studies."

Answered by AI

How is mycophenolate mofetil typically employed to treat certain ailments?

"Mycophenolate mofetil is predominantly utilized to treat B-cell lymphomas, yet it can provide therapeutic relief for polyangium, lupus nephritis and bulla."

Answered by AI

What is the number of participants enrolled in this research endeavor?

"Unfortunately, this trial has concluded its recruitment of participants. First posted on March 12th 2013 and last updated November 28 2022, the study is no longer taking applicants. However, if you are still looking for trials to participate in then there are 1750 active studies involving lymphoma or non-Hodgkin's disease and 590 others that involve mycophenolate mofetil recruiting patients currently."

Answered by AI

To what extent has research been conducted into mycophenolate mofetil?

"Presently, there are 590 clinical trials examining the effects of mycophenolate mofetil with 115 in their final phase. While a few medical centres in Philadelphia house some studies related to this drug, it is being studied at over 15000 locations worldwide."

Answered by AI

Are there available vacancies for qualified participants in this trial?

"Contrary to popular belief, clinicaltrials.gov shows that this medical study is not currently open for recruitment. Initially posted on March 12th 2013 and last updated November 28th 2022, the trial has ceased enrollment of patients; however, there are still 2340 other trials looking for participants right now."

Answered by AI

Who can qualify to partake in this experiment?

"This clinical trial seeks 20 individuals aged 19 to 75 who suffer from non-Hodgkin's lymphoma or CD20+ Hodgkin's disease. To be eligible, participants must have a Karnofsky performance status of at least 60%, life expectancy over 3 months, normal bilirubin and AST/ALT levels, creatinine clearance model >=60 ml/min/1.73 m^2 OR serum creatinine within institutional limits, recent prior chemotherapeutic regimen (excluding steroids alone), and radiotherapy completed 4 weeks before entry into the study. Additionally, all applicants must demonstrate their willingness to sign an informed"

Answered by AI