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Non-Hodgkin's LymphomaPhase 2NCT00788606

R-CHOP-B Bevacizumab for Diffuse Large B Cell Lymphoma

A Phase 2 study testing bevacizumab, Rituximab in people with Non-Hodgkin's Lymphoma and B-cell Lymphoma, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study evaluates the use of the standard treatment R-CHOP plus the anti-VEGF drug, bevacizumab and whether this treatment is feasible in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma, B-cell Lymphoma
What is being tested?
bevacizumab, Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited Kingdom
Study dates
May 2008to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

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.
  • Histological proven diffuse large B cell non-Hodgkin's lymphoma (DLBCL) according to the World Health Organization classification including morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reveiwed by a central Lymphoma Trials Office pathology panel.
  • No previous chemotherapy, radiotherapy or other investigational drug for this indication.
  • Stage II, III and IV disease.
  • WHO performance status 0<2.
  • Adequate bone marrow function with platelets > 100x109/l: neutrophils > 1.5x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma.
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  • Serum creatinine < 150μmol/l , serum bilirubin < 35μmol/l and transaminases < 2.5 x upper limit of institutional normal range unless attributed to lymphoma.
  • Normal MUGA or echocardiogram without any areas of abnormal contractility. Patients must have an acceptable left ventricular ejection fraction (LVEF) > 50%.
  • No current uncontrolled medical condition.
  • No active malignant disease other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years.
  • Adequate contraceptive precautions for all patients of childbearing potential.
  • Written, informed consent.

Who cannot join

  • T-cell lymphoma or transformed follicular lymphoma.
  • Previous history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed who have a large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
  • Past history of heart failure or uncontrolled angina pectoris.
  • Central nervous system, meningeal involvement or cord compresssion by the lymphoma
  • Cardiac contra-indication to doxorubicin (abnormal contractility on echocardiography or nuclear medicine examination[MUGA])
  • Neurological contra-indication to vincristine (e.g pre-existing diabetic neuropathy).
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  • Any other serious active disease
  • General status that does not allow the administration of 8 courses of CHOP according to the investigator
  • Positive serology for HIV, Hepatitis B or Hepatitis C
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • Bevacuzumab related criteria:
  • No major surgery, major trauma or open biopsy within 28 days prior to study entry. Patients requiring insertion of central venous access for treatment (e.g due to poor venous access) should have the procedure performed at least 2 days before starting treatment.
  • No serious, non-healing would, ulcer or bone fracture.
  • Absence of obvious risk of requiring emergency surgery after commencement of study treatmene, such as impending bowel obstruction.
  • Absense of clinically significant (i.e active) cardiovascular disease e.g. cerebrovascular accidents (<6 months prior to randomisation), myocardial infarction (< 1 year prior to randomisation), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Hearth Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhymia requiring medication.
  • No recent history of any active gastrointestinal inflammatory condition such a peptic ulcer disease, diverticulitis or inflammatory bowel disease. If patients have a known diagnosis of any of the above, evidence of disease control is required by negative endoscopy within the last 28 days.
  • No evidence of bleeding disthesis or coagulopathy.
  • No recent commencement of full oral anticoagulation (warfarin), unless stable and within therapeutic range for at least 10 days. No thrombolytic therapy within 10 days prior to commencement of study treatment.
  • No chronic, daily treatment with high-dose aspirin (> 325mg/day) or nonsteroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases).
  • No chronic treatment with corticosteriods (dose of . 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
  • No known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any other excipients of bevacizumab formulation, platinum compounds or to any other components of the study drugs.
  • No proteinuria at baseline as defined by>1g of protein/24 hr by 24-hour urine collection.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • David Cunningham, Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: Feasibility Study of R-CHOP Plus Bevacizumab in Patients With Diffuse Large B Cell Lymphoma (DLBCL)

This study evaluates the use of the standard treatment R-CHOP plus the anti-VEGF drug, bevacizumab and whether this treatment is feasible in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL).

Read the detailed description

Non-Hodgkin's lymphoma is increasing in incidence with more than 287,000 cases world-wide and 9000 cases in UK diagnosed each year. DLBCL is the most frequently occurring NHL, constituting approximately 31% of all non-Hodgkin's lymphomas.

Rituximab-CHOP chemotherapy has shown clinical efficacy and is regarded as standard treatment in patients with DLBCL. NICE has recently approved the use of rituzimab in combination with CHOP for all newly diagnosed patients with DLBCL stage II-IV.

Angiogenesis plays an important role in the pathophysiology of both solid tumours and hematologic malignancies. Vascular endothelial growth factor (VEGF) is the most important pro-angiogenic factor involved in normal and pathologic angiogenesis and studies have also implicated VEGF in lymphomagenesis. Elevated VEGF gene expression correlates with diffuse large B cell lymphoma subtypes of poor prognosis on microarray analysis. In patients with lymphoma, high circulating serum VEGF levels have been strongly associated with poor clinical outcomes independent of other predictive factors.

Bevacizumab is a humanized monoclonal antibody that binds to VEGF thus preventing binding to its receptors thus inhibiting the downstream pathways dependent on receptor stimulation. Bevacizamab has shown activity in solid tumours (colorectal, renal, breast and non-small cell lung cancer) and early results suggest that the combination of R-CHOP plus bevacizamab is feasible in patients with non Hodgkin's lymphoma.

Patients will be treated with a minimum of 6 cycles of treatment. A further 2 cycles, to a total of 8 cycles, may be administered if continuing response to treatment has been documented but residual disease is still detectable on restaging after 6 cycles. Each cycle of treatment is 21 days.

Follow up - a) Clinic visit with physical examination at 3, 6, 9, 12, 18 and 24 months after completion of R-CHOP-B, then annually.

  1. CT scan of chest, abdomen and pelvis at 3 months and 1 year after finishing treatment.
Being tested
bevacizumab, Rituximab
Keywords
diffused large B cell lymphoma, DLBCL, R-Chop, bevacizumab, Diffuse large B-cell non-Hodgkin's lymphoma.
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumab, RituximabDrug

    6 cycles of treatment. Bevacizumab at a dose of 15 mg/kg, diluted in normal saline will be administered as a intravenous infusion over 30 to 90 minutes on Day 1 of each cycle. Rituzimab 375 mg/m2 is given as a intravenous infusion after the administration of prednisolone and before the other cytotoxic drugs on Day 1 of each cycle.

Study groups in NCT00788606
Study groupRoleWhat they receive
bevacizumab and RituximabExperimentalThis study evaluates the feasibility using the anti-VEGF drug, bevacizumab, in combination with the standard treatment Rituximab in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL)
Receives: Drug: bevacizumab, Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint of this study is cardiac and bevacizumab-specific toxicity. Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events v3.0

    Measured: 1 year

Secondary outcomes (1)

  1. Response rates, failure free survival, and overall survival will be evaluated and are secondary endpoints

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2010
  4. Study completionJun 2010

Why it stopped: Toxicity and efficacy data from another trial

Resources

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788606
Sponsor's protocol ID
CCR 2719
Status last verified
Oct 2016
First submitted
10 Nov 2008
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, Rituximab in people with Non-Hodgkin's Lymphoma and B-cell Lymphoma, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.

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 12 inclusion and 22 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 14 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 2 sites in United Kingdom. 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?

The study was stopped early (reason given: Toxicity and efficacy data from another trial). Results are not available in the source record.

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?

The primary endpoint of this study is cardiac and bevacizumab-specific toxicity. Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events v3.0 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00788606.

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 14 Oct 2016.

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