NCT00119730

Brief Summary

  • The purpose of this study is to find out whether combining a short course of chemotherapy (Fludarabine, Mitoxantrone and Rituximab) followed by Zevalin will be effective in treating relapsed mantle cell lymphoma.
  • The secondary purposes of the study are to determine the safety and to evaluate whether there is additional benefit from Zevalin therapy following the chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

July 7, 2005

Last Update Submit

April 22, 2014

Conditions

Mantle Cell Lymphoma

Keywords

FludarabineMitoxantroneRituximabZevalinMantle Cell LymphomaRelapsed Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Fludarabine, Mitoxantrone, Rituximab, Zevalin

EXPERIMENTAL

Drug: 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.

Drug: FludarabineDrug: MitoxantroneDrug: RituximabDrug: Zevalin

Interventions

FludarabineDRUG

Given on days 1-3 of each 28-day cycle

Also known as: Fludara
Fludarabine, Mitoxantrone, Rituximab, Zevalin
MitoxantroneDRUG

Given on day 1 of each 28-day cycle

Also known as: Mitozantrone
Fludarabine, Mitoxantrone, Rituximab, Zevalin
RituximabDRUG

Given on day 1 of each 28-day cycle

Also known as: Rituxan, MabThera and Zytux
Fludarabine, Mitoxantrone, Rituximab, Zevalin
ZevalinDRUG

After 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.

Also known as: Ibritumomab tiuxetan
Fludarabine, Mitoxantrone, Rituximab, Zevalin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
  • An IRB-approved signed informed consent
  • Age \>/= 18 years
  • Expected survival \>/= 3 months
  • ECOG performance status 0, 1, or 2
  • Acceptable hematologic status within two weeks prior to registration, including: \* Absolute neutrophil count (\[segmented neutrophils + bands\] x total WBC) ≥ 1,500/mm3; \* Platelet counts ≥ 100,000/mm3
  • 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 Phase II 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
  • Hematologic recovery from FMR (ANC \>1500, platelets \> 100,000)
  • Stable or responding disease on restaging following two cycles of FMR
  • \< 25% of bone marrow cellularity involved with lymphoma on restaging bone marrow biopsy
  • Bone marrow cellularity at least 20% (including lymphoma and normal cells)
  • +7 more criteria

You may not qualify if:

  • Patients with impaired bone marrow reserve, as indicated by one or more of the following: \* Prior myeloablative therapies with allogeneic or autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue; \* Platelet count \< 100,000 cells/mm3; \* Prior external beam radiation to \>25% of active bone marrow; \* History of failed stem cell collection
  • Prior radioimmunotherapy
  • Known cardiac ejection fraction \< 40%. In patients with prior adriamycin exposure \>= 300 mg/m2, echocardiogram must be obtained within three months prior to registration
  • Known CNS lymphoma (lumbar puncture only required if symptomatic)
  • Chronic lymphocytic leukemia (CLL)
  • HIV or AIDS-related lymphoma
  • Pleural effusion or ascites
  • Abnormal liver function: total bilirubin \> 2.0 mg/dL (if total bilirubin is \>75% indirect, then may use direct bilirubin \> 0.8 mg/dL)
  • Abnormal renal function: serum creatinine \> 2.0 mg/dL
  • G-CSF or GM-CSF therapy within two weeks prior to treatment, or neulasta within four weeks
  • Positive direct antiglobulin test
  • Major surgery, other than diagnostic surgery, within four weeks
  • Serious nonmalignant disease or infection which in the opinion of the investigator would compromise protocol objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

fludarabinefludarabine phosphateMitoxantroneRituximabibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jennifer R Brown, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 14, 2005

Study Start

February 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2013

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

US(2)