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Mantle Cell LymphomaPhase 2NCT00891839

Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma

A Phase 2 study testing Bendamustine and Rituximab in people with Mantle Cell Lymphoma, run by Cephalon at 13 sites in 2 countries.

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 determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory 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?
Bendamustine and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
13 sitesin 2 countries
Study dates
Jun 2009to May 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • histopathologically confirmed diagnosis of typical or atypical mantle cell lymphoma, except for blastoid type.
  • documented relapsed/refractory mantle cell lymphoma.
  • CD20 positive B cells in the lymph node biopsy or other lymphoma pathology specimen.
  • adequate hematologic function according to specific trial parameters.
  • bidimensionally measurable disease with at least 1 lesion measuring 2.0 cm or more in a single dimension, or the patient is in the leukemic phase of the disease.
  • patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
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  • patient has an estimated life expectancy of at least 3 months.
  • women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
  • men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of study drug treatment and for 30 days after participation in the treatment period.

Who cannot join

  • has received more than 3 previous standard chemotherapy regimens.
  • has the blastoid subtype of mantle cell lymphoma.
  • documented history of central nervous system (CNS) lymphomatous involvement.
  • a history of previous high-dose chemotherapy with allogeneic stem cell transplantation (history of autologous stem cell transplantation is allowed).
  • previous treatment with bendamustine.
  • has an active malignancy other than MCL, or has had a malignancy other than MCL within the past 3 years, except for controlled prostate cancer without evidence of bone metastases, localized bladder cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer.
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  • has New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
  • has serum creatinine of more than 2.0 mg/dL or creatinine clearance of less than 30 mL/min based on the Cockcroft-Gault method or from a 24-hour urine collection.
  • does not have adequate hepatic organ function as evidenced by specific trial parameters.
  • has known human immunodeficiency virus (HIV) infection.
  • has active hepatitis B infection. Hepatitis B surface antigen must be tested.
  • a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • has received corticosteroids within 28 days of study entry unless chronically administered (prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications.
  • any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to participate in or complete this study.
  • any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
  • patient has received other investigational agent(s) within 28 days of study entry.
  • patient has received chemotherapy within the prior 28 days.
  • patient has a known hypersensitivity to bendamustine, mannitol, or rituximab.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States11 sites

  • Teva Investigational Site 20

    Bethesda, Maryland

  • Teva Investigational Site 33

    Bryan, Texas

  • Teva Investigational Site 3

    Buffalo, New York

  • Teva Investigational Site 11

    Fountain Valley, California

  • Teva Investigational Site 43

    Gettysburg, Pennsylvania

  • Teva Investigational Site 41

    Grapevine, Texas

  • Teva Investigational Site 4

    Hackensack, New Jersey

  • Teva Investigational Site 30

    Lafayette, Indiana

  • Teva Investigational Site 2

    Los Angeles, California

  • Teva Investigational Site 23

    Lynchburg, Virginia

  • Teva Investigational Site 35

    Orlando, Florida

Other trials in United States

Canada2 sites

  • Teva Investigational Site 6

    Ottawa

  • Teva Investigational Site 7

    Toronto

Other trials in Canada

About this study

Official title: An Open-Label Study of Bendamustine Hydrochloride in Combination With Rituximab in the Treatment of Patients With Relapsed/Refractory Mantle Cell Lymphoma

The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.

Being tested
Bendamustine, Rituximab
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.

  • BendamustineDrug

    Also called bendamustine HCl, TREANDA®, CEP-18083

    Bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.

  • RituximabDrug

    Also called Rituxan

    Patients receive 375 mg/m^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.

Study groups in NCT00891839
Study groupRoleWhat they receive
Bendamustine+RituximabExperimentalPatients receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
Receives: Drug: Bendamustine; Drug: Rituximab

What is being measured

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

  1. Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria

    The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.

    95% CIs are calculated using binomial exact method.

    Measured: Month 3 (end of cycle 3), Month 6 (end of cycle 6)

Secondary outcomes (5)

  1. Kaplan-Meier Estimate for Duration of Response

    Duration of response is defined as the time between the date of the first response to date of progression or death. Response is determined on the basis of the 2007 IWG criteria. A complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.

    Measured: Day 1 up to Month 43

  2. Kaplan-Meier Estimate for Progression-Free Survival

    Progression-free survival is defined as the time from first exposure to study medication to disease progression or relapse, or death due to any cause. Progression is defined using the 2007 International Working Group criteria, as any new lesion or increase by at least 50% of previously involved sites from nadir.

    Measured: Day 1 up to Month 45

  3. Kaplan-Meier Estimate for Overall Survival

    Overall survival is defined as the time from first exposure to study medication to death, or to last date from adverse events, concomitant medications, vital signs, lost to follow-up, or last known alive, for overall survival censoring date.

    Measured: Day 1 up to Month 57

  4. Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)

    Participants had a whole-body PET at baseline and at the end of cycle 6 or the end-of-treatment visit. Negative PET refers to PET results showing no abnormal lymph nodes; conversely, positive PET refers to PET results showing abnormal lymph nodes.

    Measured: Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)

  5. Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

    The ECOG scale is:

    • Grade 0: Fully active, able to carry on all pre-disease activities without restriction;
    • Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
    • Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;
    • Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
    • Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.

    The shift table compares baseline ECOG scores to the ECOG scores as of the last treatment visit.

    Measured: Day 0 (baseline) up to Month 8

Timeline

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

  1. First posted1 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionDec 2011
  4. Study completionMay 2014

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891839
Sponsor's protocol ID
C18083/2039/NL/US-CA
Status last verified
Oct 2014
First submitted
29 Apr 2009
Last updated
4 Nov 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine and Rituximab in people with Mantle Cell Lymphoma, run by Cephalon at 13 sites in 2 countries.

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 9 inclusion and 18 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 22 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria (time frame: Month 3 (end of cycle 3), Month 6 (end of cycle 6)). 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 NCT00891839.

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 4 Nov 2014.

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