LeukemiaPhase 2NCT00816595
Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study testing bevacizumab, pegfilgrastim and rituximab in people with Leukemia and Lymphoma, run by Mayo Clinic at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- What is being tested?
- bevacizumab, pegfilgrastim and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to 29 Nov 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Biopsy proven small lymphocytic lymphoma (SLL)
- Chronic lymphocytic leukemia (CLL)* as evidenced by the following criteria:
- Peripheral blood lymphocyte count > 5,000/mm³ consisting of small to moderate size lymphocytes
- Immunophenotyping consistent with CLL, defined by the following:
- The predominant population of lymphocytes share both B-cell antigens (CD19, CD20, or CD23) as well as CD-5 in the absence of other pan-T-cell markers (CD-3 or CD-2)
- Dim surface immunoglobulin expression
- Exclusively kappa and lambda light chains
- Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy samples NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
- Has ≥ 1 of the following indications** for chemotherapy:
- Evidence of progressive marrow failure as manifested by the development of or worsening anemia (hemoglobin ≤ 11 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm³)
- Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
- Has ≥ 1 of the following disease-related symptoms:
- Weight loss > 10% within the past 6 months
- Extreme fatigue attributed to CLL
- Fevers > 100.5^oF for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months NOTE: **Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient indications for study treatment
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group performance status 0-3
- Life expectancy ≥ 12 months
- Total bilirubin ≤ 3.0 times upper limit of normal (ULN) (unless due to Gilbert's disease)
- Direct bilirubin < 1.5 mg/dL (in patients with Gilbert's disease)
- Serum glutamate oxaloacetate transaminase ≤ 3.0 times ULN (unless due to hepatic involvement by CLL)
- Creatinine ≤ 1.5 times ULN
- Urine protein:creatinine ratio < 1.0 OR < 1 g of protein by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- Willing to provide mandatory blood and tissue samples
- None of the following cardiovascular conditions:
- NYHA class III-IV heart disease
- Myocardial infarction within the past 6 months
- Unstable angina
- Stroke, cerebrovascular accident, or transient ischemic attack within the past 6 months
- Arterial thromboembolic events within the past 12 months
- Clinically significant peripheral vascular disease
- Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg
- Hypertension allowed provided it is controlled with a stable anti-hypertensive regimen
- History of hypertensive crises or hypertensive encephalopathy
- Deep venous thromboses or pulmonary embolism within the past 12 months
- No evidence of bleeding diathesis or coagulopathy
- No uncontrolled or active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
- No active or recent history (within the past 30 days) of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No active peptic ulcer disease
- No serious non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No uncontrolled infection
- No active HIV infection
- No other active primary malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting survival to ≤ 2 years
- No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
- Prior corticosteroids allowed
- More than 4 weeks since prior radiotherapy
- More than 28 days since prior and no concurrent major surgical procedure or open biopsy
- More than 7 days since prior minor surgical procedure, fine needle aspiration, or core biopsy (other than bone marrow biopsy)
- No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
- Doses of ≤ 2 mg daily allowed for prophylaxis of thrombosis
- Prophylactic doses of low molecular weight heparin allowed
- No other concurrent investigational agents for treatment of CLL or SLL
- No other concurrent specific anticancer treatment except hormonal therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- To assess the rate of complete and overall response in patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma treated with pentostatin, cyclophosphamide, and rituximab with or without bevacizumab.
- To assess the proportion of patients who achieve a negative minimal residual disease state after treatment with these regimens.
- To monitor and assess the adverse events of these regimens.
Secondary
- To determine if molecular prognostic parameters (ZAP-70, CD38, cytogenetic abnormalities identified by FISH, and IgVH mutation status) relate to response in these patients.
- To determine the progression-free survival of patients treated with these regimens.
- To complete additional correlative studies to gain insight into disease biology and how it influences drug sensitivity.
OUTLINE: Patients are stratified according to Rai risk group (high [Rai stage III or IV] vs low [Rai stage 0] or intermediate [Rai stage I or II]) and FISH prognosis group (favorable [normal, +12, 13q-, or other] vs unfavorable [17p- or 11q-]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and pentostatin IV over 30 minutes and cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days* for 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Course 6 is 56 days in duration
- Arm II: Patients receive rituximab IV over 2-4 hours on days 1 and 2 of course 1 and on day 1 of courses 2-6 and pentostatin IV over 30 minutes and cyclophosphamide IV over 30 minutes on day 1. Patients also receive pegfilgrastim SC on day 2. Treatment repeats every 21 days* for 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Course 6 is 56 days in duration
Patients undergo blood sample collection and bone marrow biopsy/aspiration periodically for translational research studies. Samples are analyzed by flow cytometry for assessment of minimal residual disease. Molecular prognostic markers (including CD38, ZAP-70, IgVH gene mutation status, and cytogenetic abnormalities by FISH), Tcl-1 and CD49d protein expression, and immunoglobulin heavy chain D and J family gene usage are also analyzed. Plasma samples are stored for future studies evaluating levels of VEGF, bFGF, and thrombospondin by ELISA.
After completion of study therapy, patients are followed periodically for up to 5 years.
- Being tested
- bevacizumab, pegfilgrastim, rituximab, cyclophosphamide, pentostatin
- Keywords
- B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called Avastin
Given IV
pegfilgrastimBiological
Given subcutaneously
rituximabBiological
Given IV
cyclophosphamideDrug
Given IV
pentostatinDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | Experimental | Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: bevacizumab; Biological: pegfilgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: pentostatin |
| Arm B: Pentostatin, Cyclophosphamide, and Rituximab | Experimental | Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: pegfilgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: pentostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and Overall Response Rate
A Complete Response (CR) requires all of the following for 2 months:
- Absence of lymphadenopathy by physical examination (PE)
- No hepato- or splenomegaly by PE
- Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL
Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples.
A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available.
A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin.
Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients.
Measured: Evaluated after 6 cycles (up to 196 days)
Secondary outcomes (2)
Overall Survival
The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause.
Measured: Assessed up to 5 years from registration
Progression-free Survival
The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first.
Measured: Assessed up to 5 years from registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completion29 Nov 2016
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tait D. Shanafelt, MD, Study chair, Mayo ClinicJose F. Francisco, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816595
- Sponsor's protocol ID
- CDR0000630491
- Other IDs
- P30CA015083, RC0783, 08-002080, AVF4491s, NCI-2009-01225
- Status last verified
- May 2017
- First submitted
- 31 Dec 2008
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00816595
- Acronym / sponsor ID
- CDR0000630491
- Keywords
- B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- 29 Nov 2016 (actual)
- First posted
- 1 Jan 2009 (estimated)
- Results
- Posted 9 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed description
OBJECTIVES:
Primary
- To assess the rate of complete and overall response in patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma treated with pentostatin, cyclophosphamide, and rituximab with or without bevacizumab.
- To assess the proportion of patients who achieve a negative minimal residual disease state after treatment with these regimens.
- To monitor and assess the adverse events of these regimens.
Secondary
- To determine if molecular prognostic parameters (ZAP-70, CD38, cytogenetic abnormalities identified by FISH, and IgVH mutation status) relate to response in these patients.
- To determine the progression-free survival of patients treated with these regimens.
- To complete additional correlative studies to gain insight into disease biology and how it influences drug sensitivity.
OUTLINE: Patients are stratified according to Rai risk group (high [Rai stage III or IV] vs low [Rai stage 0] or intermediate [Rai stage I or II]) and FISH prognosis group (favorable [normal, +12, 13q-, or other] vs unfavorable [17p- or 11q-]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and pentostatin IV over 30 minutes and cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days* for 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Course 6 is 56 days in duration
- Arm II: Patients receive rituximab IV over 2-4 hours on days 1 and 2 of course 1 and on day 1 of courses 2-6 and pentostatin IV over 30 minutes and cyclophosphamide IV over 30 minutes on day 1. Patients also receive pegfilgrastim SC on day 2. Treatment repeats every 21 days* for 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Course 6 is 56 days in duration
Patients undergo blood sample collection and bone marrow biopsy/aspiration periodically for translational research studies. Samples are analyzed by flow cytometry for assessment of minimal residual disease. Molecular prognostic markers (including CD38, ZAP-70, IgVH gene mutation status, and cytogenetic abnormalities by FISH), Tcl-1 and CD49d protein expression, and immunoglobulin heavy chain D and J family gene usage are also analyzed. Plasma samples are stored for future studies evaluating levels of VEGF, bFGF, and thrombospondin by ELISA.
After completion of study therapy, patients are followed periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | Experimental | Biological: bevacizumab, Biological: pegfilgrastim, Biological: rituximab, Drug: cyclophosphamide, Drug: pentostatinPatients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
| Arm B: Pentostatin, Cyclophosphamide, and Rituximab | Experimental | Biological: pegfilgrastim, Biological: rituximab, Drug: cyclophosphamide, Drug: pentostatinPatients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bevacizumabAlso: AvastinGiven IV | Biological | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin |
| pegfilgrastimGiven subcutaneously | Biological | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin, Arm B: Pentostatin, Cyclophosphamide, and Rituximab |
| rituximabGiven IV | Biological | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin, Arm B: Pentostatin, Cyclophosphamide, and Rituximab |
| cyclophosphamideGiven IV | Drug | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin, Arm B: Pentostatin, Cyclophosphamide, and Rituximab |
| pentostatinGiven IV | Drug | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin, Arm B: Pentostatin, Cyclophosphamide, and Rituximab |
Primary outcome
Complete and Overall Response Rate
Time frame: Evaluated after 6 cycles (up to 196 days)
A Complete Response (CR) requires all of the following for 2 months: * Absence of lymphadenopathy by physical examination (PE) * No hepato- or splenomegaly by PE * Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available. A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin. Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients.
2 secondary outcomes
Overall Survival
Time frame: Assessed up to 5 years from registration
Progression-free Survival
Time frame: Assessed up to 5 years from registration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- 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.
Tait D. Shanafelt, MD study chair
Mayo Clinic
Jose F. Francisco, M.D. principal investigator
Mayo Clinic
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, pegfilgrastim and rituximab in people with Leukemia and Lymphoma, run by Mayo Clinic 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?
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 15 Jun 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 9 May 2014). 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 and Overall Response Rate (time frame: Evaluated after 6 cycles (up to 196 days)). 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 15 Jun 2017.