Recent Updates
Recently added Catalysts

Zevalin

Phase 2

Mantle Cell Lymphoma | Small molecule | Oncology |Biogen Inc.|Last Updated: Apr 24, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Zevalin · 1 trial · 1 indication

Phase 2 1
NCT00119730Chemotherapy Followed by Zevalin for Relapsed Mantle Cell LymphomaMantle Cell Lymphoma
COMPLETED30 Analytics
PHASE2COMPLETED
Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma
Mantle Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to determine the response rate to two cycles of FMR + Zevalin in patients with relapsed mantle cell lymphoma, using a two-stage design.
2 years

Secondary Endpoints

To describe the progression-free survival
To determine the safety of FMR + Zevalin in these subjects
2 years
To determine the impact of Zevalin on minimal residual disease in subjects with relapsed mantle cell lymphoma
2 years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fludarabine, Mitoxantrone, Rituximab, ZevalinEXPERIMENTALDrug: Fludarabine Given on days 1-3 of each 28-day cycle Drug: Mitoxantrone Given on day 1 of each 28-day cycle Drug: Rituximab Given on day 1 of each 28-day cycle Drug: Zevalin Given after two cycles if there is no disease progression.

Interventions

NameTypeDescription
FludarabineDRUGGiven on days 1-3 of each 28-day cycle
MitoxantroneDRUGGiven on day 1 of each 28-day cycle
RituximabDRUGGiven on day 1 of each 28-day cycle
ZevalinDRUGAfter two cycles if there is no disease progression, zevalin treatment will be given. Rituximab will be given followed by an imaging dose of zevalin. Two or three scans will be performed over a week to determine if it is safe to give the full treatment dose of zevalin. The treatment dose is given with the second infusion or rituximab, seven days after the first dose.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically confirmed mantle cell lymphoma in 1st or 2nd relapse, or with persistent disease following induction therapy. * Measurable disease (lymph node \> 1.5 cm) * No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Zevalin

What is Zevalin used for?

Zevalin is used for the treatment of Mantle Cell Lymphoma, a type of non-Hodgkin lymphoma. It is being studied as part of a chemotherapy regimen followed by Zevalin for patients with relapsed disease. The drug is currently in clinical development for this indication.

Who makes Zevalin?

Zevalin is developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Mantle Cell Lymphoma.

What phase is Zevalin in?

Zevalin is in Phase 2 clinical development for Mantle Cell Lymphoma. A Phase 2 trial has been completed, which enrolled 30 participants in the United States. The drug is investigational and has not yet been approved for this use.

What clinical trials is Zevalin in?

Zevalin has one completed clinical trial, identified as NCT00119730, titled "Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma." This Phase 2 study enrolled 30 patients in the United States and was not randomized or blinded.

Is Zevalin a small molecule drug?

Yes, Zevalin is classified as a small molecule drug. It is being developed as an oncology treatment for Mantle Cell Lymphoma, and its clinical trial included biomarker-selected patients, indicating a targeted approach to patient selection.