Follicular LymphomaPhase 2NCT00901927
Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
A Phase 2 study testing Bendamustine, Mitoxantrone and Rituximab in people with Follicular Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Bendamustine, Mitoxantrone and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jan 2016
- 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
- Age >18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.
- At least one measurable lesion according to the International Working Group Criteria for Response, of greater that 1.5cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of < 2 at study entry.
- Laboratory test results within these ranges: Absolute neutrophil count >/=1.5 x 10^9/L; Platelet count >/=100 x 10^9/L; Serum creatinine </= 2.0 mg/dL; Total bilirubin </= 1.5 mg/dL; AST (SGOT) and ALT (SGPT) </= 2 x upper limit of normal (ULN) or </= 5 x ULN if hepatic metastases are present.
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- Disease free of prior malignancies for at least 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
- Have a high risk FLIPI score, as defined by a FLIPI score >/= 3.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 to 14 days prior to study entry.
- An ejection fraction of >/= 50% as documented by a cardiac function study.
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any prior chemotherapy for follicular lymphoma.
- Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.
- A history of congestive heart failure.
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- Any prior use of bendamustine or mitoxantrone.
- Concurrent use of other anti-cancer agents or experimental treatments.
- Known positive for HIV or infectious hepatitis type B or C.
- Creatinine clearance less than 40 ml/min.
- A known history of hepatic insufficiency (patients with a history of fulminate hepatic failure, hepatic encephalopathy, cirrhosis, and autoimmune hepatitis).
- Any history of grade 3b follicular lymphoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.
The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.
Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells.
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 the study drugs in 28-day "cycles."
On Days 1 and 2 of each cycle, you will receive bendamustine through a needle in a vein over 30-60 minutes.
On Day 1 of each cycle, you will receive rituximab by vein over several hours, depending on how well you tolerate it. Usually, the first dose of rituximab is given over 6-8 hours. If you tolerate the first dose well, you will receive the next doses over 4 hours.
On Day 2 of each cycle, you will receive mitoxantrone by vein over 15 minutes.
Study Visits:
At every study visit (Days 1, 8, 15, and 22 of each cycle), your vital signs will be measured. You will be asked if you have experienced any side effects and to list any drugs you may be taking. The measurement of vital signs on Days 8, 15, and 22 of each cycle may be done by your personal doctor, and the results can be sent in to the study staff.
On Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have a performance status evaluation.
On Days 8, 15, and 22 of each cycles, blood (about 1 teaspoon) will be drawn for routine tests. These tests may be performed by your personal doctor, and the results can be sent in to the study staff.
At the end of Cycle 3, you will have a positron emission tomography (PET) scan and/or CT scan to check the status of the disease.
If your bone marrow showed lymphoma at the beginning of the study, you will have an additional bone marrow aspiration and biopsy if the disease goes away while you are on study. This will be to check the status of the disease.
If at any time the doctor thinks it is necessary, you will have extra blood and urine collected for routine tests.
Length of Study Participation:
You may receive up to 6 cycles (about 6 months) of study treatment. If the disease gets worse or intolerable side effects occur, you will be taken off study treatment early.
End-of-Study Visit:
At 30-40 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have CT and PET scans to check the status of the disease.
- You will be asked if you have experienced any side effects and to list any drugs you may be taking.
Long-Term Follow-Up:
Every 3 months for 2 years after your study treatment ends, you will have follow-up visits. If after 2 years your body shows no signs of cancer, you will have follow-up visits every 6 months after that. These follow-up tests are considered routine care.
The following tests and procedures will be performed at these visits:
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will be asked how you are doing and whether you are receiving any new treatments for the disease.
- You will have CT and PET scans to check the status of the disease.
- The study doctor will check the results of any other scans and tests you may have for routine care. The study doctor will also check the results of physical exams you may have.
This is an investigational study. All 3 study drugs are commercially available. Rituximab is FDA approved to treat follicular lymphoma. Mitoxantrone is FDA approved for use in combination for certain types of leukemia. Bendamustine is FDA approved to treat chronic lymphocytic leukemia.
The combination of rituximab, mitoxantrone, and bendamustine is not FDA approved to treat follicular lymphoma. At this time, it is only being used in research.
Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Follicular Lymphoma
- Being tested
- Bendamustine, Mitoxantrone, Rituximab
- Keywords
- Lymphoma, Non-Hodgkin's Lymphoma, Untreated High Risk Follicular Lymphoma, Bendamustine hydrochloride, Bendamustine HCI, Bendamustine, CEP-18083, SDX-105, Treanda, Mitoxantrone, Novantrone, Rituximab, Rituxan
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Bendamustine Hydrochloride, Bendamustine HCI, CEP-18083, SDX-105
Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.
MitoxantroneDrug
Also called Novantrone
10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle.
RituximabDrug
Also called Rituxan
375 mg/m^2 by vein over several hours on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine + Mitoxantrone + Rituximab | Experimental | Bendamustine starting dose 90 mg/m^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 IV over several hours on Day 1 of each cycle. Receives: Drug: Bendamustine; Drug: Mitoxantrone; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)
To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
Measured: 3 months
Secondary outcomes (2)
Participants With Adverse Events
To evaluate the toxicity and safety of BMR in participants with untreated follicular lymphoma.
Measured: 3 months
Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Study was closed early due to toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Nathan Fowler, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901927
- Sponsor's protocol ID
- 2008-0204
- Other IDs
- NCI-2012-01629
- Status last verified
- Apr 2020
- First submitted
- 12 May 2009
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT00901927
- Acronym / sponsor ID
- 2008-0204
- Conditions
- Follicular Lymphoma
- Keywords
- Lymphoma, Non-Hodgkin's Lymphoma, Untreated High Risk Follicular Lymphoma, Bendamustine hydrochloride, Bendamustine HCI, Bendamustine, CEP-18083, SDX-105
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed early due to toxicity
- Enrolment
- 14 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- May 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.
The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.
Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells.
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 the study drugs in 28-day "cycles."
On Days 1 and 2 of each cycle, you will receive bendamustine through a needle in a vein over 30-60 minutes.
On Day 1 of each cycle, you will receive rituximab by vein over several hours, depending on how well you tolerate it. Usually, the first dose of rituximab is given over 6-8 hours. If you tolerate the first dose well, you will receive the next doses over 4 hours.
On Day 2 of each cycle, you will receive mitoxantrone by vein over 15 minutes.
Study Visits:
At every study visit (Days 1, 8, 15, and 22 of each cycle), your vital signs will be measured. You will be asked if you have experienced any side effects and to list any drugs you may be taking. The measurement of vital signs on Days 8, 15, and 22 of each cycle may be done by your personal doctor, and the results can be sent in to the study staff.
On Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have a performance status evaluation.
On Days 8, 15, and 22 of each cycles, blood (about 1 teaspoon) will be drawn for routine tests. These tests may be performed by your personal doctor, and the results can be sent in to the study staff.
At the end of Cycle 3, you will have a positron emission tomography (PET) scan and/or CT scan to check the status of the disease.
If your bone marrow showed lymphoma at the beginning of the study, you will have an additional bone marrow aspiration and biopsy if the disease goes away while you are on study. This will be to check the status of the disease.
If at any time the doctor thinks it is necessary, you will have extra blood and urine collected for routine tests.
Length of Study Participation:
You may receive up to 6 cycles (about 6 months) of study treatment. If the disease gets worse or intolerable side effects occur, you will be taken off study treatment early.
End-of-Study Visit:
At 30-40 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have CT and PET scans to check the status of the disease.
- You will be asked if you have experienced any side effects and to list any drugs you may be taking.
Long-Term Follow-Up:
Every 3 months for 2 years after your study treatment ends, you will have follow-up visits. If after 2 years your body shows no signs of cancer, you will have follow-up visits every 6 months after that. These follow-up tests are considered routine care.
The following tests and procedures will be performed at these visits:
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will be asked how you are doing and whether you are receiving any new treatments for the disease.
- You will have CT and PET scans to check the status of the disease.
- The study doctor will check the results of any other scans and tests you may have for routine care. The study doctor will also check the results of physical exams you may have.
This is an investigational study. All 3 study drugs are commercially available. Rituximab is FDA approved to treat follicular lymphoma. Mitoxantrone is FDA approved for use in combination for certain types of leukemia. Bendamustine is FDA approved to treat chronic lymphocytic leukemia.
The combination of rituximab, mitoxantrone, and bendamustine is not FDA approved to treat follicular lymphoma. At this time, it is only being used in research.
Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine + Mitoxantrone + Rituximab | Experimental | Drug: Bendamustine, Drug: Mitoxantrone, Drug: RituximabBendamustine starting dose 90 mg/m^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 IV over several hours on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.
- At least one measurable lesion according to the International Working Group Criteria for Response, of greater that 1.5cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of < 2 at study entry.
Key exclusion criteria (12 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any prior chemotherapy for follicular lymphoma.
- Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BendamustineAlso: Bendamustine Hydrochloride, Bendamustine HCI, CEP-18083, SDX-105Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle. | Drug | Bendamustine + Mitoxantrone + Rituximab |
| MitoxantroneAlso: Novantrone10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle. | Drug | Bendamustine + Mitoxantrone + Rituximab |
| RituximabAlso: Rituxan375 mg/m^2 by vein over several hours on Day 1 of each cycle. | Drug | Bendamustine + Mitoxantrone + Rituximab |
Primary outcome
Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)
Time frame: 3 months
To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
2 secondary outcomes
Participants With Adverse Events
Time frame: 3 months
Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab)
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Fowler, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine, Mitoxantrone and Rituximab in people with Follicular 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 12 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: stopped early, as of the sponsor's last update on 3 Apr 2020. 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 3 Apr 2020). 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?
Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.