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LymphomaPhase 2NCT00974792

Combination Chemotherapy and Rituximab in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma

A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by Cancer Research UK at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy 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, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lymphoma
What is being tested?
pegfilgrastim, rituximab and cyclophosphamide
How many people
150 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2006to May 2011
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma
  • International Prognostic Index (IPI) score high-intermediate (score = 3) OR high (score = 4 or 5), defined as:
  • Stage III or IV disease
  • Raised lactic dehydrogenase and poor performance status (WHO performance status 2-4)
  • All morphological variants included
  • B-cell nature of the proliferation must be verified by a positive anti-CD20 antibody (i.e., CD20-positive disease)
  • No T-cell lymphoma
  • No history of treated or non-treated indolent lymphoma
  • Patients newly diagnosed who have large B-cell lymphoma with some small cell infiltration in the bone marrow or lymph node may be allowed

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Life expectancy > 3 months
  • ANC > 1,500/mm^3*
  • Platelet count > 100,000/mm^3*
  • Serum creatinine < 150 μmol/L*
  • Serum bilirubin < 35 μmol/L*
  • AST and/or ALT < 2.5 times upper limit of normal* NOTE: *Unless attributed to bone marrow infiltration by lymphoma.
  • Fertile patients must use effective contraception
  • Normal MUGA or echocardiogram without areas of abnormal contractility
  • LVEF ≥ 50% and only tested if patient meets 1 of the following criteria:
  • History of diabetes
  • Prior cardiac disease, hypertension, or abnormal resting ECG
  • No history of heart failure or uncontrolled angina pectoris
  • No cardiac contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on echocardiography or MUGA)
  • No neurological contraindication to vincristine sulfate (e.g., pre-existing diabetic neuropathy)
  • No concurrent uncontrolled medical condition
  • No other serious active disease
  • No general status that, according to the investigator, does not allow the administration of 2 courses of CODOX-M/IVAC
  • No active malignant disease within the past 10 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  • No positive serology for HIV or hepatitis B or C
  • No medical or psychiatric conditions that compromise the patient's ability to give informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy, radiotherapy, or other investigational drug for diffuse large B-cell non-Hodgkin lymphoma

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

    A. McMillan, 44-115-969-1169

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk)

RATIONALE: Drugs used in chemotherapy 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, can block cancer cell 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 cell-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with diffuse large B-cell non-Hodgkin lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the complete response rate in patients with high- or high/intermediate-risk diffuse large B-cell lymphoma treated with CODOX-M/IVAC comprising cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, methotrexate, ifosfamide, etoposide phosphate, and cytarabine with rituximab.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on days 1 and 11 and CODOX-M comprising doxorubicin hydrochloride IV on day 1, cyclophosphamide IV on days 1-5, vincristine sulfate IV on days 1 and 8, methotrexate IV over 12 hours on day 10, and leucovorin calcium IV or orally every 3-6 hours beginning 24-36 hours after methotrexate. Patients also receive CNS prophylaxis comprising cytarabine intrathecally (IT) on days 1 and 3 and methotrexate IT on day 15. Patients with high-risk disease receive an additional dose of cytarabine IT on day 5 and methotrexate IT on day 17. Patients also receive pegfilgrastim subcutaneously (SC) on day 11. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of CODOX-M course 1, patients receive rituximab IV on day 1** and IVAC comprising etoposide phosphate IV over 1 hour and ifosfamide IV over 1 hour on days 1-5, cytarabine IV over 3 hours (every 12 hours) on days 1 and 2, and methotrexate IT on day 5. Patients with high-risk disease receive cytarabine IT on days 7 and 9. Patients also receive pegfilgrastim SC on day 7. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

NOTE: **Patients with high-risk disease also receive rituximab IV on days 21 and 42 after day 1 of course 4 (IVAC).

Treatment with R-CODOX-M and R-IVAC repeats every 28 days alternatively for 2 courses each in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Conditions
Lymphoma
Keywords
stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

What is being measured

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

  1. Complete response rate

Secondary outcomes (2)

  1. Toxicity

  2. Progression-free survival

Timeline

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

  1. First posted10 Sep 2009 (estimated)
  2. Study startJan 2006
  3. Primary completionMay 2011 (estimated)

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
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974792
Sponsor's protocol ID
CDR0000644893
Other IDs
CRUK-UCL-R-CODOX-M/IVAC, EUDRACT-2005-003479-19, EU-20956
Status last verified
Sep 2009
First submitted
9 Sep 2009
Last updated
26 Aug 2013
Results posted
No

Publications

  • McMillan AK, Phillips EH, Kirkwood AA, Barrans S, Burton C, Rule S, Patmore R, Pettengell R, Ardeshna KM, Lawrie A, Montoto S, Paneesha S, Clifton-Hadley L, Linch DC. Favourable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3-5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial. Ann Oncol. 2020 Sep;31(9):1251-1259. doi: 10.1016/j.annonc.2020.05.016. Epub 2020 May 26.

    PubMed 32464282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by Cancer Research UK at 1 site 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?

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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate. 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 NCT00974792, which also lists 1 linked publication.

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 26 Aug 2013.

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