Untreated Mantle Cell LymphomaPhase 2NCT00401817
Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma
A Phase 2 study testing Bevacizumab, Rituximab and CHOP in people with Untreated Mantle Cell Lymphoma, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
Primary Objective 1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated Mantle Cell Lymphoma
- What is being tested?
- Bevacizumab, Rituximab and CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Nov 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
- Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-)
- Patient has not received any prior anti-cancer therapy for lymphoma
- Laboratory parameters (unless considered by investigator to be due to lymphoma):
- Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin > 7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN
- Patient has at least one tumor mass > 1.5 cm in one dimension
- Available tumor tissue for correlative studies (rebiopsy to be performed if needed)
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- Patient is > 18 years old
- Patient has KPS > 50%
- Patient has signed IRB-approved informed consent
- Patient agrees to use birth control for duration of study
Who cannot join
- Known central nervous system (CNS) involvement by lymphoma
- Known hepatitis infection
- Known HIV positivity
- Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0 at screening
- Uncontrolled hypertension: blood pressure of >150/100 mmHg at screening
- Unstable angina
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- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Patient has ejection fraction < 50%
- Patient is taking coumadin, or has known history of thrombosis within last 6 months
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Serious, non-healing wound, ulcer, or bone fracture
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Patient is pregnant or nursing
- Patient is receiving other investigational drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
Primary Objective
- To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).
Secondary Objectives
- To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
- To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.
Read the detailed description
Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles
Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)
Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment
Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
- Conditions
- Untreated Mantle Cell Lymphoma
- Being tested
- Bevacizumab, Rituximab, CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
15 mg/kg on day 1 of each of 6 cycles
RituximabDrug
Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.
The dose to be administered is:
Rituximab: 375 mg/m2
CHOPDrug
Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment Arm | Experimental | Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Receives: Drug: Bevacizumab; Drug: Rituximab; Drug: CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Toxicity
Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Measured: 38 months
Secondary outcomes (3)
Overall Response Rate
Overall Response Rate measured using Kaplan-Meier survival analysis
Response criteria were those reported by Cheson et al. (1999)
Measured: 38 Months (min 33 months, max 62 months)
Progression-Free Survival
The percentage of patients who have not progressed at the three year time point.
The 3-year PFS rate was estimated based on the Kaplan-Meier analysis.
Measured: 3 years
Overall Survival
The percentage of patients who have survived at the three year time point.
The 3-year OS rate was estimated based on the Kaplan-Meier analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2007
- Primary completionJul 2011
- Study completionNov 2013
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 Untreated Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Leonard, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401817
- Sponsor's protocol ID
- 0604008463
- Status last verified
- Sep 2017
- First submitted
- 20 Nov 2006
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT00401817
- Acronym / sponsor ID
- 0604008463
- Conditions
- Untreated Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective
- To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).
Secondary Objectives
- To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
- To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.
Detailed description
Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles
Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)
Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment
Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment Arm | Experimental | Drug: Bevacizumab, Drug: Rituximab, Drug: CHOPBevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-)
- Patient has not received any prior anti-cancer therapy for lymphoma
- Laboratory parameters (unless considered by investigator to be due to lymphoma):
- Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin > 7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN
- Patient has at least one tumor mass > 1.5 cm in one dimension
Key exclusion criteria (20 listed)
- Known central nervous system (CNS) involvement by lymphoma
- Known hepatitis infection
- Known HIV positivity
- Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0 at screening
- Uncontrolled hypertension: blood pressure of >150/100 mmHg at screening
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 |
|---|---|---|
| Bevacizumab15 mg/kg on day 1 of each of 6 cycles | Drug | Study Treatment Arm |
| RituximabRituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles. The dose to be administered is: Rituximab: 375 mg/m2 | Drug | Study Treatment Arm |
| CHOPStandard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7 | Drug | Study Treatment Arm |
Primary outcome
Number of Participants With Toxicity
Time frame: 38 months
Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
3 secondary outcomes
Overall Response Rate
Time frame: 38 Months (min 33 months, max 62 months)
Progression-Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
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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.
John P Leonard, MD principal investigator
Weill Medical College of Cornell University
2 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 Bevacizumab, Rituximab and CHOP in people with Untreated Mantle Cell Lymphoma, run by Weill Medical College of Cornell University at 2 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 20 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 20 Oct 2017). 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?
Number of Participants With Toxicity (time frame: 38 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 20 Oct 2017.