Relapsed or Refractory Mantle Cell Lymphoma (MCL)Phase 2NCT00656084
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
A Phase 2 study testing gemcitabine, mitoxantrone and rituximab in people with Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by US Oncology Research.
Trial summary
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- What is being tested?
- gemcitabine, mitoxantrone and rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jan 2008
- 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
- Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
- Is CD20 positive (by immunohistochemistry or FACS)
- Is Cyclin D positive (by immunohistochemistry or FACS)
- Has received prior chemotherapy (required minimum of 1 prior therapies)
- Has received prior treatment with Rituxan
- Has an ECOG Performance Status (PS) 0-2
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- Is greater than or equal to 18 years of age
- Has appropriate laboratory values (please refer to protocol for specific laboratory values)
- If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
- Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
- If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
- Has signed a Patient Informed Consent Form
- Has signed a Patient Authorization Form
Who cannot join
- Has other lymphomas not classified as MCL
- Has had prior treatment with Gemzar and/or Novantrone
- A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
- Has a history of hypersensitivity to murine-cell derived therapeutics
- Has a LVEF indicative of a cardiac condition (LVEF < 50%)
- Is receiving concurrent immunotherapy
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- Has evidence of CNS involvement
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
- Is a pregnant or nursing woman
- Is unable to comply with requirements of study
About this study
Official title: A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
- Being tested
- gemcitabine, mitoxantrone, rituximab
- Medical subject headings
- Recurrence, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Also called Gemzar
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.
mitoxantroneDrug
Also called Novantrone
Novantrone 10 mg/m2on Day 1. The order of administration will be:
Gemzar-->Novantrone-->Rituxan.
rituximabDrug
Also called Rituxan
Rituxan 375 mg/m2 on Day 1. The order of administration will be:
Gemzar-->Novantrone-->Rituxan.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab. Receives: Drug: gemcitabine; Drug: mitoxantrone; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (CR + PR)
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Measured: 2 years
Secondary outcomes (3)
Duration of Response
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Measured: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
Overall Survival (OS) Rate at 1 Year
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Measured: 1 year.
Progression-free Survival Rate at 1 Year.
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startDec 2004
- Primary completionJan 2007
- Study completionJan 2008
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 Relapsed or Refractory Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Investigators
- Lawrence Garbo, MD, Principal investigator, US Oncology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656084
- Sponsor's protocol ID
- 04-026
- Status last verified
- Sep 2016
- First submitted
- 4 Apr 2008
- Last updated
- 3 Nov 2016
- 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 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
- ClinicalTrials.gov ID
- NCT00656084
- Acronym / sponsor ID
- 04-026
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 3 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: gemcitabine, Drug: mitoxantrone, Drug: rituximabPatients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
- Is CD20 positive (by immunohistochemistry or FACS)
- Is Cyclin D positive (by immunohistochemistry or FACS)
- Has received prior chemotherapy (required minimum of 1 prior therapies)
- Has received prior treatment with Rituxan
Key exclusion criteria (11 listed)
- Has other lymphomas not classified as MCL
- Has had prior treatment with Gemzar and/or Novantrone
- A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
- Has a history of hypersensitivity to murine-cell derived therapeutics
- Has a LVEF indicative of a cardiac condition (LVEF < 50%)
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 |
|---|---|---|
| gemcitabineAlso: Gemzar900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan. | Drug | Experimental arm |
| mitoxantroneAlso: NovantroneNovantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan. | Drug | Experimental arm |
| rituximabAlso: RituxanRituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan. | Drug | Experimental arm |
Primary outcome
Objective Response Rate (CR + PR)
Time frame: 2 years
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
3 secondary outcomes
Duration of Response
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
Overall Survival (OS) Rate at 1 Year
Time frame: 1 year.
Progression-free Survival Rate at 1 Year.
Time frame: 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lawrence Garbo, MD principal investigator
US Oncology Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, mitoxantrone and rituximab in people with Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by US Oncology Research.
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 13 inclusion and 11 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Nov 2016). 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?
Objective Response Rate (CR + PR) (time frame: 2 years). 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 Nov 2016.