Burkitt's LymphomaPhase 2NCT00669877
Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Burkitt's Lymphoma and Burkitt'S-like Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if intensive chemotherapy given over 6 months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment works when given with Rituximab. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burkitt's Lymphoma, Burkitt'S-like Lymphoma
- What is being tested?
- Rituximab, Cyclophosphamide and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Oct 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burkitt's or Burkitt-like leukemia and/or lymphoma, either previously untreated, previously treated (may be in CR or with active disease after 1-2 courses of chemotherapy), or HIV-related.
- All ages are eligible.
- Zubrod performance status < 3 (ECOG Scale, Appendix A).
- Adequate liver function (bilirubin < 3.0 mg/dL, unless considered due to tumor), and renal function (creatinine < 3.0 mg/dL, unless considered due to tumor).
- Signed informed consent.
Who cannot join
- 1) N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if intensive chemotherapy given over 6 months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment works when given with Rituximab. The safety of the combined treatment will also be studied.
Read the detailed description
The hyper-CVAD regimen is a combination of chemotherapy drugs including cyclophosphamide, vincristine, Adriamycin, and dexamethasone given together to for one "course" of treatment. This alternates with a course or combination of the chemotherapy drugs methotrexate and cytarabine. Rituximab is a protein (monoclonal antibody) that attaches to the surface of the leukemia or lymphoma cells which have a marker called cluster of differentiation antigen 20 (CD20).
During treatment, participants will have a physical exam and give blood samples (about 1 tablespoon each) at least twice a week. After two courses of chemotherapy, the tests done before treatment will be repeated to check for response. In patients with leukemia, a bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check the response.
All participants in this study will receive 2 kinds of chemotherapy courses for a total of 8 courses. Chemotherapy courses will be given through a large vein by a central venous catheter (a plastic tube usually placed under the collarbone).
In Course 1 (odd course), participants will receive rituximab by vein over 6 hours on Days 1 and 11. Participants will receive the drugs acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl) 30-60 minutes before each dose of rituximab. This will be done to lessen the risk of fever, chills, and allergic reactions. Usually, the first dose of rituximab requires about 6 hours to complete.
Participants will then receive cyclophosphamide by vein over 2-3 hours every 12 hours for a total of 6 doses, given over 3 days (Days 1, 2, and 3). Adriamycin will be given by vein over 24 hours on Day 4. Vincristine will be given by vein over 15 to 30 minutes on Days 4 and 11 along with dexamethasone by mouth or by vein on Days 1-4 and 11-14.
Participants will also receive pegfilgrastim or G-CSF (growth stimulating colony factor) to help with rapid recovery of the normal bone marrow starting after each course of chemotherapy is finished. Pegfilgrastim is injected under the skin within 72 hours of completion of each cycle of chemotherapy. G-CSF is given by injections by vein or under the skin until the blood counts recover.
Treatment to the brain will be given inside the spinal fluid with cytarabine and methotrexate about Days 2 and 7 of the course to help prevent the leukemia from developing there.
For patients 60 years or older, the first course will be given in a protective isolation room to decrease the risk of infection(s).
In Course 2 (even course), participants will receive rituximab by infusion over about 4 hours on Days 1 and 8. They will receive methotrexate by infusion over 24 hours on the first day, and cytarabine in a high dose over 2 hours every 12 hours for 4 doses (Days 2 and 3). Citrovorum factor (leucovorin) will be given by vein or by mouth for 2-3 days (Day 2 and on) to decrease the risk of side effects of methotrexate. G-CSF will be given as in Course 1 (after the chemotherapy is finished). The treatment to the brain inside the spinal fluid will be given as in course 1 on days 2 and 7.
After two courses of therapy, the response to the treatment will be checked. If the leukemia or lymphoma is responding, the therapy will be continued for a total of 8 courses over 6 months. Therapy will be stopped if the leukemia or lymphoma starts to get worse.
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to decrease the risk of leukemia in patients who have difficulty with the spinal treatments. An Ommaya reservoir is a tube inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain.
This is an investigational study. All drugs in this study are commercially available. Their use together in this study is investigational. About 70 patients or more will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Burkitt's Lymphoma, Burkitt'S-like Lymphoma
- Being tested
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone
- Keywords
- Burkitt's Lymphoma, Burkitt's Like Lymphoma, Leukemia, Hyper-CVAD, Rituximab, Methotrexate, Cytarabine
- Medical subject headings
- Burkitt Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses.
CyclophosphamideDrug
Also called Cytoxan, Neosar
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses).
DoxorubicinDrug
Also called Adriamycin, Rubex
50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
VincristineDrug
Also called Oncovin, Vincasar Pfs
2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses)
DexamethasoneDrug
Also called Decadron
40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses)
G-CSFDrug
Also called Filgrastim, Neupogen
10 mcg/kg
CytarabineDrug
Also called Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
MethotrexateDrug
Also called Rheumatrex, Methotrexate Sodium, MTX
200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab.
| Study group | Role | What they receive |
|---|---|---|
| Hyper-CVAD | Experimental | Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: G-CSF; Drug: Cytarabine; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate: Percentage of Participants With Complete Remission (CR)
Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR.
Measured: After two 21-day courses, response to treatment checked for Complete Remission (CR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startAug 2002
- Primary completionOct 2015
- Study completionOct 2015
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 Burkitt's LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan O'Brien, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669877
- Sponsor's protocol ID
- ID02-229
- Other IDs
- NCI-2010-01455
- Status last verified
- Apr 2018
- First submitted
- 28 Apr 2008
- Last updated
- 16 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT00669877
- Acronym / sponsor ID
- ID02-229
- Conditions
- Burkitt's Lymphoma, Burkitt'S-like Lymphoma
- Keywords
- Burkitt's Lymphoma, Burkitt's Like Lymphoma, Leukemia, Hyper-CVAD, Rituximab, Methotrexate, Cytarabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 16 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if intensive chemotherapy given over 6 months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment works when given with Rituximab. The safety of the combined treatment will also be studied.
Detailed description
The hyper-CVAD regimen is a combination of chemotherapy drugs including cyclophosphamide, vincristine, Adriamycin, and dexamethasone given together to for one "course" of treatment. This alternates with a course or combination of the chemotherapy drugs methotrexate and cytarabine. Rituximab is a protein (monoclonal antibody) that attaches to the surface of the leukemia or lymphoma cells which have a marker called cluster of differentiation antigen 20 (CD20).
During treatment, participants will have a physical exam and give blood samples (about 1 tablespoon each) at least twice a week. After two courses of chemotherapy, the tests done before treatment will be repeated to check for response. In patients with leukemia, a bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check the response.
All participants in this study will receive 2 kinds of chemotherapy courses for a total of 8 courses. Chemotherapy courses will be given through a large vein by a central venous catheter (a plastic tube usually placed under the collarbone).
In Course 1 (odd course), participants will receive rituximab by vein over 6 hours on Days 1 and 11. Participants will receive the drugs acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl) 30-60 minutes before each dose of rituximab. This will be done to lessen the risk of fever, chills, and allergic reactions. Usually, the first dose of rituximab requires about 6 hours to complete.
Participants will then receive cyclophosphamide by vein over 2-3 hours every 12 hours for a total of 6 doses, given over 3 days (Days 1, 2, and 3). Adriamycin will be given by vein over 24 hours on Day 4. Vincristine will be given by vein over 15 to 30 minutes on Days 4 and 11 along with dexamethasone by mouth or by vein on Days 1-4 and 11-14.
Participants will also receive pegfilgrastim or G-CSF (growth stimulating colony factor) to help with rapid recovery of the normal bone marrow starting after each course of chemotherapy is finished. Pegfilgrastim is injected under the skin within 72 hours of completion of each cycle of chemotherapy. G-CSF is given by injections by vein or under the skin until the blood counts recover.
Treatment to the brain will be given inside the spinal fluid with cytarabine and methotrexate about Days 2 and 7 of the course to help prevent the leukemia from developing there.
For patients 60 years or older, the first course will be given in a protective isolation room to decrease the risk of infection(s).
In Course 2 (even course), participants will receive rituximab by infusion over about 4 hours on Days 1 and 8. They will receive methotrexate by infusion over 24 hours on the first day, and cytarabine in a high dose over 2 hours every 12 hours for 4 doses (Days 2 and 3). Citrovorum factor (leucovorin) will be given by vein or by mouth for 2-3 days (Day 2 and on) to decrease the risk of side effects of methotrexate. G-CSF will be given as in Course 1 (after the chemotherapy is finished). The treatment to the brain inside the spinal fluid will be given as in course 1 on days 2 and 7.
After two courses of therapy, the response to the treatment will be checked. If the leukemia or lymphoma is responding, the therapy will be continued for a total of 8 courses over 6 months. Therapy will be stopped if the leukemia or lymphoma starts to get worse.
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to decrease the risk of leukemia in patients who have difficulty with the spinal treatments. An Ommaya reservoir is a tube inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain.
This is an investigational study. All drugs in this study are commercially available. Their use together in this study is investigational. About 70 patients or more will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyper-CVAD | Experimental | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Dexamethasone, Drug: G-CSF, Drug: Cytarabine, Drug: MethotrexateHyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Burkitt's or Burkitt-like leukemia and/or lymphoma, either previously untreated, previously treated (may be in CR or with active disease after 1-2 courses of chemotherapy), or HIV-related.
- All ages are eligible.
- Zubrod performance status < 3 (ECOG Scale, Appendix A).
- Adequate liver function (bilirubin < 3.0 mg/dL, unless considered due to tumor), and renal function (creatinine < 3.0 mg/dL, unless considered due to tumor).
- Signed informed consent.
Key exclusion criteria (1 listed)
- 1) N/A
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 |
|---|---|---|
| RituximabAlso: Rituxan375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. | Drug | Hyper-CVAD |
| CyclophosphamideAlso: Cytoxan, Neosar300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses). | Drug | Hyper-CVAD |
| DoxorubicinAlso: Adriamycin, Rubex50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). | Drug | Hyper-CVAD |
| VincristineAlso: Oncovin, Vincasar Pfs2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses) | Drug | Hyper-CVAD |
| DexamethasoneAlso: Decadron40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses) | Drug | Hyper-CVAD |
| G-CSFAlso: Filgrastim, Neupogen10 mcg/kg | Drug | Hyper-CVAD |
| CytarabineAlso: Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses). | Drug | Hyper-CVAD |
| MethotrexateAlso: Rheumatrex, Methotrexate Sodium, MTX200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab. | Drug | Hyper-CVAD |
Primary outcome
Complete Remission Rate: Percentage of Participants With Complete Remission (CR)
Time frame: After two 21-day courses, response to treatment checked for Complete Remission (CR)
Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Susan O'Brien, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Burkitt's Lymphoma and Burkitt'S-like Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 5 inclusion and 1 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 16 May 2018. 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 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 16 May 2018). 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 Remission Rate: Percentage of Participants With Complete Remission (CR) (time frame: After two 21-day courses, response to treatment checked for Complete Remission (CR)). 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 16 May 2018.