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Burkitt LymphomaPhase 2NCT00126191

Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Burkitt Lymphoma and Non-Hodgkins Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Terminated

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

Official record
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Trial summary

The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab, Cyclophosphamide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
Jul 2005to Jun 2011
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 documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria.
  • Pathology must be reviewed at the Brigham and Women's Hospital (BWH).
  • Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease.
  • The following may not be used as the sole site of measurable or evaluable disease: *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease.
  • Age > 18
  • Laboratory data (within 2 weeks of study registration):
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  • ANC > 1500/ul;
  • platelet > 100,000/ul;
  • creatinine < 1.5 X normal;
  • creatinine clearance > 60 ml/min;
  • bilirubin < 1.5 X normal;
  • AST and ALT < 2.5 X normal;
  • alkaline phosphates < 3 X normal;
  • HIV negative;
  • cardiac ejection fraction > 50%.

Who cannot join

  • Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration for impending oncologic emergency are allowed.
  • Uncontrolled bacterial, fungal, or viral infection.
  • Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell carcinoma of the skin.
  • Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital capacity (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide diffusing capacity of the lung (DLCO) of > 50% predicted. No clinically significant cardiac symptomatology. The cardiac ejection fraction must be > 50%.
  • Pregnancy. All males and females with reproductive potential must consent to use an effective form of contraception while on study.
  • Major surgery within the previous 2 weeks.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma

The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.

Read the detailed description
  • Patients will be placed into one of two groups, "low risk" and "high risk". "Low risk" disease is defined as one area of disease measuring less than 10cm and a normal blood test called LDH (lactate hydrogenase). Patients not fitting the "low risk" criteria are considered "high risk".
  • If the patient has "low risk" disease their treatment cycle consist of three cycles of A.
  • If the patient has "high risk" disease they will receive Cycle A followed by cycle B which will then repeat.
  • Cycle A consists of the drugs: rituximab, cyclophosphamide, oncovin, doxorubicin and methotrexate (R-CODOX-M). The treatment cycle is approximately 14 days. A spinal tap is performed on day 1 and day 3 of the cycle and the patient will be hospitalized until between day 11 and day 13. After the patient's blood counts return to normal(usually around day 21),the next round of treatment will occur.
  • Cycle B consists of the drugs: rituximab, ifosfamide, VP-16 and ara-c (IVAC). The treatment cycle is approximately 5 days. A spinal tap is performed on day 4 and once blood counts return to normal the patient will start cycle A again.
  • After the patient has finished the treatments, they will be re-evaluated with CT scans and PET scans to determine whether or not they are in remission. Every three months for two years, blood tests and CT and PET scans will be performed. Follow up after that will be every 6 months for two years.
Keywords
Burkitt Lymphoma, atypical Burkitt lymphoma, Non-Hodgkin's Lymphoma, rituximab
Medical subject headings
Burkitt Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

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

  • RituximabDrug

    Also called Rituxan

    Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1

  • CyclophosphamideDrug

    Also called Cytoxan

    Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)

  • DoxorubicinDrug

    Also called Adriamycin, Rubex

    Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)

  • VincristineDrug

    Also called Oncovin, vincristine sulfate

    Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)

  • MethotrexateDrug

    Also called Rheumatrex, Trexall

    Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle

  • LeucovorinDrug

    Also called Folinic acid

    Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)

  • IfosfamideDrug

    Also called Ifex

    High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle

  • EtoposideDrug

    Also called Vepesid

    High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle

  • CytarabineDrug

    Also called Cytosar, Tarabine PFS

    Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle

  • MesnaDrug

    Also called Mesnex

    High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle

Study groups in NCT00126191
Study groupRoleWhat they receive
Low RiskExperimentalLow-risk patients receive 3 cycles of regimen A. Regimen A: Rituximab (375 mg/m^2) on Days 1 and 3. Cyclophosphamide (800 mg/m^2) on days 1 and 2. Vincristine (1.4 mg/m^2) on days 1 and 10. Doxorubicin (50 mg/m^2) on Day 1. Methotrexate (3000 mg/m^2) on Day 10. Intrathecal Cytarabine (50mg) will be given on Day 1 and intrathecal methotrexate (12mg) will be given on Days 1 and 10. Leucovorin on days 11 and 12. Rituximab is given on Days 1 and 3 in cycle 1, and on Day 1 of all other cycles.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Methotrexate; Drug: Leucovorin; Drug: Cytarabine
High RiskExperimentalHigh-risk patients receive 4 alternating cycles of regimens A and B (A-B-A-B). Regimen A (as described earlier). Regimen B: Rituximab (375mg/m^2) on Day 1. Ifosfamide (1500mg/m^2) on Days 1-5. Mesna (275 mg/m^2) on Days 1-5. Etoposide (60mg/mg^2) on Days 1-5. Cytarabine (2 gm/m^2) twice a day on Days 1 and 2. Intrathecal methotrexate (12mg) on Day 5, and intrathecal methotrexate (50mg) on Day 3 (also on Day 1 for patients with central nervous system involvement).
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Methotrexate; Drug: Leucovorin; Drug: Ifosfamide; Drug: Etoposide; Drug: Cytarabine; Drug: Mesna

What is being measured

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

  1. Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt

    Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed.

    Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable.

    Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment.

    Measured: 3 years

Secondary outcomes (1)

  1. Disease Free Survival

    Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.

    Measured: Until disease progression up to 120 months

Timeline

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

  1. First posted3 Aug 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2009
  4. Study completionJun 2011

Why it stopped: closed due to slow accrual

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
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00126191
Sponsor's protocol ID
04-336
Status last verified
Apr 2013
First submitted
2 Aug 2005
Last updated
23 May 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Burkitt Lymphoma and Non-Hodgkins Lymphoma, run by Dana-Farber Cancer Institute 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 15 inclusion and 6 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 23 May 2013. 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 23 May 2013). 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?

Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt (time frame: 3 years). 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 NCT00126191.

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 23 May 2013.

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