Lymphoma, Non-HodgkinPhase 2NCT01186458
Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
A Phase 2 study testing Fludarabine, Velcade and Rituximab in people with Lymphoma, Non-Hodgkin, run by Hoosier Cancer Research Network at 11 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Fludarabine, Velcade and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2010to Oct 2013
- 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
- Must have histologically confirmed Follicular Non-Hodgkin Lymphoma (Grade I, II, or IIIa)
- Must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥2 cm with conventional techniques or as >1 cm with spiral CT scan) and obtained by imaging within 30 days prior to registration for protocol therapy.
- Must have received at least one prior therapeutic regimen, but no more than three prior regimens of conventional cytotoxic therapy. NOTE: Prior recipients of stem cell transplantation will be included, with the preparative cytoreductive and high-dose therapies counted collectively as one prior therapy.
- Must be off all cytotoxic chemotherapy for at least four weeks prior to registration for protocol therapy (6 weeks for BCNU or mitomycin C).
- Patients are allowed to have received one course of prior radioimmunotherapy (RIT: either tositumomab or ibritumomab). NOTE: Radioimmunotherapy must be completed at least 12 weeks prior to registration for protocol therapy with recovery to baseline of ANC and platelets.
- Prior fludarabine, Velcade or rituximab is allowed as long as therapy is completed at least 30 days prior to registration for protocol therapy. Patients may be refractory (defined as not responding or demonstrating progressive disease in <6 months) to prior rituximab. Patients may not be refractory to prior fludarabine or Velcade.
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- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed and for 30 days following protocol therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to prior to registration for protocol therapy. NOTE: Patients are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (no menses for at least 12 months).
- Females must not be breastfeeding.
- Males must agree to use an acceptable method of contraception for the duration of the study.
Who cannot join
- No current active CNS metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 7 days prior to registration for protocol therapy. NOTE: Patients with treated brain metastasis must be off steroids or on tapering or stable doses of steroids and have completed radiation at least 30 days prior to registration for protocol therapy.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason ≤ grade 6 prostate cancers, or other cancer for which the subject has been disease-free for at least 3 years.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- Prior radiation therapy is allowed to < 25% of the bone marrow. NOTE: No radiation therapy within 30 days prior to registration for protocol therapy.
- No clinically significant infections as judged by the treating investigator.
- No active HIV, hepatitis B or hepatitic C infection.
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- No cerebrovascular accident (CVA) within 6 months of study enrollment.
- No psychiatric illness/social situations that would limit compliance with study requirements.
- No history of hypersensitivity to Velcade, boron or mannitol.
- No peripheral neuropathy grade > 1.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Case Comprehensive Cancer Center - University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Seidman Cancer Center
Cleveland, Ohio, 44106
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Community Regional Cancer Center
Indianapolis, Indiana, 46256
Arnett Cancer Care
Lafayette, Indiana, 47904
Virtua Health Cancer Program
Mount Holly, New Jersey, 08060
University of Rochester Medical Center
Rochester, New York, 14642
South Jersey Health Care
Vineland, New Jersey, 08360
Reading Hospital Regional Cancer Center
West Reading, Pennsylvania, 19611
About this study
Official title: A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134
The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin lymphoma.
Read the detailed description
OUTLINE: This is a multi-center study.
- Fludarabine 25 mg/m2 IV over 30 minutes , Days 1, 2, 4
- Velcade(given after fludarabine) 1.3 mg/m2 IV push over 3 to 5 seconds, Days 1, 4, 8, 11
- Rituximab (given after Velcade) 375 mg/m2 IV piggyback, Day 1
- Cycle = 28 days; max 6 cycles
ECOG Performance Status: 0-2
Life Expectancy: Not specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 (ANC > 0.5 K/mm3 if known lymphomatous involvement of the bone marrow).
- Platelets ≥ 100 K/mm3 (Platelets >50 K/mm3 if known lymphomatous involvement of the bone marrow).
Hepatic:
- Total bilirubin ≤1.5 ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN
Renal:
- Creatinine < 1.5 x institutional upper limit (ULN) or creatinine clearance ≥ 50 cc/min
Cardiovascular:
- No myocardial infarction within 6 months prior to enrollment
- No heart failure per New York Heart Association Classification III or IV
- No severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Fludarabine, Velcade, Rituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
VelcadeDrug
Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
RituximabDrug
Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine, Velcade and Rituximab | Experimental | Fludarabine, Velcade and Rituximab Receives: Drug: Fludarabine; Drug: Velcade; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.
Measured: 6 months
Secondary outcomes (3)
Survival
To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.
Measured: 6 months
Toxicity
To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.
Measured: 6 months
Biologic Interaction
To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Slow accrual
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 Lymphoma, Non-HodgkinStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Shivani Srivastava, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186458
- Sponsor's protocol ID
- HOG LYM08-134
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2010
- Last updated
- 24 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134
- ClinicalTrials.gov ID
- NCT01186458
- Acronym / sponsor ID
- HOG LYM08-134
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Genentech, Inc., Millennium Pharmaceuticals, Inc.
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Posted 24 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin lymphoma.
Detailed description
OUTLINE: This is a multi-center study.
- Fludarabine 25 mg/m2 IV over 30 minutes , Days 1, 2, 4
- Velcade(given after fludarabine) 1.3 mg/m2 IV push over 3 to 5 seconds, Days 1, 4, 8, 11
- Rituximab (given after Velcade) 375 mg/m2 IV piggyback, Day 1
- Cycle = 28 days; max 6 cycles
ECOG Performance Status: 0-2
Life Expectancy: Not specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 (ANC > 0.5 K/mm3 if known lymphomatous involvement of the bone marrow).
- Platelets ≥ 100 K/mm3 (Platelets >50 K/mm3 if known lymphomatous involvement of the bone marrow).
Hepatic:
- Total bilirubin ≤1.5 ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN
Renal:
- Creatinine < 1.5 x institutional upper limit (ULN) or creatinine clearance ≥ 50 cc/min
Cardiovascular:
- No myocardial infarction within 6 months prior to enrollment
- No heart failure per New York Heart Association Classification III or IV
- No severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludarabine, Velcade and Rituximab | Experimental | Drug: Fludarabine, Drug: Velcade, Drug: RituximabFludarabine, Velcade and Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have histologically confirmed Follicular Non-Hodgkin Lymphoma (Grade I, II, or IIIa)
- Must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥2 cm with conventional techniques or as >1 cm with spiral CT scan) and obtained by imaging within 30 days prior to registration for protocol therapy.
- Must have received at least one prior therapeutic regimen, but no more than three prior regimens of conventional cytotoxic therapy. NOTE: Prior recipients of stem cell transplantation will be included, with the preparative cytoreductive and high-dose therapies counted collectively as one prior therapy.
- Must be off all cytotoxic chemotherapy for at least four weeks prior to registration for protocol therapy (6 weeks for BCNU or mitomycin C).
- Patients are allowed to have received one course of prior radioimmunotherapy (RIT: either tositumomab or ibritumomab). NOTE: Radioimmunotherapy must be completed at least 12 weeks prior to registration for protocol therapy with recovery to baseline of ANC and platelets.
Key exclusion criteria (10 listed)
- No current active CNS metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 7 days prior to registration for protocol therapy. NOTE: Patients with treated brain metastasis must be off steroids or on tapering or stable doses of steroids and have completed radiation at least 30 days prior to registration for protocol therapy.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason ≤ grade 6 prostate cancers, or other cancer for which the subject has been disease-free for at least 3 years.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- Prior radiation therapy is allowed to < 25% of the bone marrow. NOTE: No radiation therapy within 30 days prior to registration for protocol therapy.
- No clinically significant infections as judged by the treating investigator.
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 |
|---|---|---|
| FludarabineFludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy. | Drug | Fludarabine, Velcade and Rituximab |
| VelcadeVelcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy. | Drug | Fludarabine, Velcade and Rituximab |
| RituximabRituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy. | Drug | Fludarabine, Velcade and Rituximab |
Primary outcome
Overall Response Rate
Time frame: 6 months
To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.
3 secondary outcomes
Survival
Time frame: 6 months
Toxicity
Time frame: 6 months
Biologic Interaction
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Oncology Group HomepageLink 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.
Shivani Srivastava, M.D. study chair
Hoosier Cancer Research Network
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Velcade and Rituximab in people with Lymphoma, Non-Hodgkin, run by Hoosier Cancer Research Network at 11 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 10 inclusion and 10 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 24 Oct 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?
Overall Response Rate (time frame: 6 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 24 Oct 2016.