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Mantle Cell LymphomaPhase 2NCT00958256

Study of Bortezomib in Combination With Cyclophosphamide and Rituximab

A Phase 2 study testing Bortezomib, Rituximab and Cyclophosphamide in people with Mantle Cell Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 goal of this clinical research study is to learn if bortezomib when given in combination with cyclophosphamide and rituximab can help to control mantle cell lymphoma. The safety of this drug combination will also continue to be studied. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Mantle Cell Lymphoma, Lymphoma
What is being tested?
Bortezomib, Rituximab and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Aug 2009to Mar 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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis mantle cell lymphoma and its variants, excluding marginal zone and disease exclusively in the GI system. Patients should have measurable disease based on Cheson Criteria or Bone Marrow/tissue sample positive for mantle cell lymphoma. No prior therapy with a combination of bortezomib, cyclophosphamide and rituximab.
  • Patients with performance status of 2 or less (Zubrod).
  • Serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl unless due to lymphoma; absolute neutrophil count (ANC) >1000/mm^3 and platelets >100,000/mm^3 unless due to lymphoma.
  • Cardiac ejection fraction 50% or greater.
  • Ages 18 to 85.
  • Patients must be willing to receive transfusions of blood products.
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  • Signed consent form.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse.
  • Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.

Who cannot join

  • Human immunodeficiency virus (HIV) infection.
  • Central nervous system (CNS) involvement.
  • Patient has a platelet count of < 100 K (eg <30 x 10^9/L for studies with bortezomib alone) within 14 days before enrollment.
  • Patient has an absolute neutrophil count of ANC (eg <1.0 x 10^9/L for studies with bortezomib alone)> within 14 days before enrollment.
  • Patient has > 1.5 times Total Bilirubin
  • Patient has a calculated or measured creatinine clearance of < 20 mL/minute creatinine clearance (eg <20 mL/minute for studies with bortezomib alone) > within 14 days before enrollment.
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  • Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to bortezomib, boron or mannitol.
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days the start of this trial and throughout the duration of this trial.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
  • Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival at 5 years).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study of Bortezomib in Combination With Cyclophosphamide and Rituximab for Relapsed/Refractory Mantle Cell Lymphoma

The goal of this clinical research study is to learn if bortezomib when given in combination with cyclophosphamide and rituximab can help to control mantle cell lymphoma. The safety of this drug combination will also continue to be studied.

Read the detailed description

The Study Drugs:

Bortezomib is designed to block a protein that plays a role in cell function and growth. This may cause cancer cells to die.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive all of the study drugs preferably through a central venous catheter (CVC) that will be left in place the entire time that you are receiving the study drugs. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. You will sign a separate consent form for this procedure, which will describe the procedure and the risk in more detail.

You will receive rituximab by vein over 6 hours on Day 1 of every 21-day study cycle.

You will receive bortezomib by vein over 3 to 5 seconds, after you have received rituximab on Day 1 of every cycle. You will also receive bortezomib on Days 4, 8, and 11 of every cycle.

You will receive cyclophosphamide by vein over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle. On these days, you will also receive mesna by vein non-stop. Mesna is a drug that protects the bladder from damage by chemotherapy drugs. It is used to decrease the risk of bleeding in the bladder.

You will receive G-CSF (filgrastim - a drug that is used to help build your white blood cell counts and prevent infections) as an injection under the skin starting 24-36 hours after you receive bortezomib. You will receive filgrastim 1 time each day until your white blood cell counts recover.

Study Visits:

At each study visit, you will be asked about how you are feeling and about any other drugs that you may be taking.

Throughout the study, blood (about 1 tablespoon each time) will be drawn 2-3 times a week for routine tests.

Within 2 days before each cycle, the following tests and procedures will be performed:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • You will complete the questionnaire about nervous system side effects.
  • Your performance status will be recorded.
  • Blood (about 2 tablespoons) will be drawn for routine tests.

After every 2 cycles, the following tests and procedures will be performed:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • Your performance status will be recorded.
  • You will have a chest x-ray or CT scans to check the status of the disease. These scans may be of your head, neck, chest, stomach, and/or pelvis. The CT scan at Cycle 4 will only occur if the doctor thinks it is needed.
  • Blood (about 5 teaspoons) will be drawn for routine tests.
  • If your doctor thinks it is needed, you will have a bone marrow biopsy/aspirate to check the status of the disease.
  • If your doctor thinks it is needed, you will have an ECHO or a multigated radionuclide angiography (MUGA) scan and/or an ECG.

You will have an exam of the colon (colonoscopy) to check the status of the disease after Cycle 2. Biopsy samples (about 3-6) of the colon will be taken during this exam to check the status of the disease.

After Cycles 2, 6, and/or 8, if your doctor thinks it is needed, you will have a positron emission tomography (PET) scan to check the status of the disease.

After Cycle 6, you will be taken off study if the disease is in "complete remission" (if the disease has disappeared). Otherwise, you may receive 2 more cycles of study treatment.

If you are receiving 2 more cycles, if colonoscopy was done after Cycle 2 and it showed lymphoma, you will have another colonoscopy after Cycle 6 and Cycle 8 to check the status of the disease. Biopsy samples (about 3-6) of the colon will be taken during this exam to check the status of the disease.

Length of Study:

You will receive the study drugs for up to 8 cycles (about 8 months). You will be taken off study early if the disease gets worse or intolerable side effects occur before Cycle 8, or if the disease is in complete remission after Cycle 6.

End-of-Treatment Visit:

After you have finished receiving the study drugs, the following tests and procedures will be performed:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • You will complete the questionnaire about nervous system side effects.
  • Your performance status will be recorded.
  • You will have a chest x-ray or CT scans to check the status of the disease.
  • Blood (about 5 teaspoons) will be drawn for routine tests.
  • If your doctor thinks it is needed, you will have a bone marrow biopsy/aspirate to check the status of the disease.
  • If your doctor thinks it is needed, you will have an ECHO or a MUGA scan and/or an ECG.

Follow-Up Visits:

After you have finished receiving the study drugs, you will have follow-up visits according to the following schedule:

  • Every 3 months during Year 1 after treatment.
  • Every 4 months during Year 2 after treatment
  • Every 6 months during Years 3-4 after treatment.
  • Every 12 months after Year 4 after treatment.

At each of the follow-up visits, the following tests and procedures will be performed:

  • You will have a complete physical exam, including measurement of your weight and vital signs.
  • You will complete the questionnaire about nervous system side effects.
  • Your medical history will be recorded
  • Your performance status will be recorded.
  • Blood (around 1 tablespoon) will be drawn for routine tests.
  • You will have a chest x-ray to check the status of the disease.
  • You will have CT scans of the head, neck, chest, abdomen, and pelvis to check the status of the disease.
  • If the doctor thinks it is needed, you will have a bone marrow aspirate/biopsy to check the status of the disease.

This is an investigational study. All of the drugs used in this study are FDA approved and commercially available for the treatment of various types of lymphoma. The use of this drug combination is investigational.

Up to 46 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.

Keywords
Mantle Cell Lymphoma, Lymphoma, Bortezomib, Velcade, Rituximab, Rituxan, Cyclophosphamide, Cytoxan, Neosar, Mesna, Mesnex, G-CSF, Filgrastim, Neupogen
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma

What participants receive

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

  • BortezomibDrug

    Also called Velcade

    Bortezomib 1.3 mg/m^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.

  • RituximabDrug

    Also called Rituxan

    375 mg/m^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

    300 mg/m^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle

  • MesnaDrug

    Also called Mesnex

    600 mg/m^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.

  • G-CSFDrug

    Also called Filgrastim, Neupogen, Granulocyte-colony stimulating factor, GCSF

    5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.

Study groups in NCT00958256
Study groupRoleWhat they receive
Bortezomib with Cyclophosphamide and RituximabExperimentalBortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
Receives: Drug: Bortezomib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Mesna; Drug: G-CSF

What is being measured

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

  1. Response Rate

    Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.

    Measured: Evaluation of disease after 2 cycles (approximately 6 weeks).

Timeline

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

  1. First posted13 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMar 2014
  4. Study completionMar 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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00958256
Sponsor's protocol ID
2009-0057
Other IDs
X05290, NCI-2009-01577
Status last verified
Mar 2015
First submitted
11 Aug 2009
Last updated
13 Apr 2015
Data monitoring committee
No

Publications

  • Lee HJ, Romaguera JE, Feng L, Desai AP, Zhang L, Fanale M, Samaniego F, Hagemeister FB, Fayad LE, Rodriguez MA, Medeiros JL, Hartig K, Nomie K, Ahmed M, Badillo M, Ye H, Oki Y, Lin P, Nastoupil L, Westin J, Wang M. Phase II Study of Bortezomib in Combination with Cyclophosphamide and Rituximab for Relapsed or Refractory Mantle Cell Lymphoma. Oncologist. 2017 May;22(5):549-553. doi: 10.1634/theoncologist.2016-0328. Epub 2017 Apr 13.

    PubMed 28408615

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib, Rituximab and Cyclophosphamide in people with Mantle Cell Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 10 inclusion and 14 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 13 Apr 2015). 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?

Response Rate (time frame: Evaluation of disease after 2 cycles (approximately 6 weeks).). 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 NCT00958256, which also lists 1 linked publication.

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 13 Apr 2015.

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