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Mantle Cell LymphomaPhase 2NCT00119730

Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma

A Phase 2 study testing Fludarabine, Mitoxantrone and Rituximab in people with Mantle Cell Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Fludarabine, Mitoxantrone and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
Feb 2005to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Total bilirubin < 2.0 mg/dL (if total bilirubin is >75% indirect, then may use direct bilirubin < 0.8 mg/dL)
  • Serum creatinine < 2.0 mg/dL
  • No G-CSF or GM-CSF therapy within two weeks prior to Zevalin treatment, or neulasta within four weeks prior to Zevalin treatment
  • No evidence of altered biodistribution of 111-In-Zevalin as indicated by:
  • Absent cardiac blood pool on day 1, with high liver / spleen uptake
  • Lung uptake greater than blood pool on day 1 or greater than liver on day 2-3
  • Kidney (in posterior view) or bowel uptake greater than liver on day 2-3

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Abbreviated Fludarabine / Mitoxantrone / Rituximab Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma

  • 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.
Read the detailed description
  • Patients receive fludarabine (days 1-3), mitoxantrone (day 1), and rituximab (day 1) of each 28-day cycle.
  • Patients undergo a CT scan and bone marrow biopsy after two cycles. Unless the cancer has progressed, the patient will then receive Zevalin study treatment.
  • Blood counts are taken every week for 12 weeks. After 12 weeks, a CT scan and bone marrow biopsy are performed.
  • Long-term followup is 4 years. Physical exam and blood work is performed every 3 months for the first two years. Following that, physical exams and blood work is every 6 months for another two years. CT scans and bone marrow biopsies are every 6 months during this 4 year followup period.
Being tested
Fludarabine, Mitoxantrone, Rituximab, Zevalin
Keywords
Fludarabine, Mitoxantrone, Rituximab, Zevalin, Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FludarabineDrug

    Also called Fludara

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

  • MitoxantroneDrug

    Also called Mitozantrone

    Given on day 1 of each 28-day cycle

  • RituximabDrug

    Also called Rituxan, MabThera and Zytux

    Given on day 1 of each 28-day cycle

  • ZevalinDrug

    Also called Ibritumomab tiuxetan

    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.

Study groups in NCT00119730
Study groupRoleWhat they receive
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.
Receives: Drug: Fludarabine; Drug: Mitoxantrone; Drug: Rituximab; Drug: Zevalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (3)

  1. To describe the progression-free survival

  2. To determine the safety of FMR + Zevalin in these subjects

    Measured: 2 years

  3. To determine the impact of Zevalin on minimal residual disease in subjects with relapsed mantle cell lymphoma

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionDec 2006
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00119730
Sponsor's protocol ID
04-251
Status last verified
Apr 2014
First submitted
7 Jul 2005
Last updated
24 Apr 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine, Mitoxantrone and Rituximab in people with Mantle Cell Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00119730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.

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