Trial · NCT00392990
Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma
NCT00392990, Phase 2, Completed, Northwestern University; results first posted 2019-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma. Trials, record NCT00392990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00392990
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma
- NCT number
- NCT00392990
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Lymphoma
- Interventions
- Regimen A, Regimen B
- First posted
- 2006-10-26
- Last updated
- 2019-10-15
- Results first posted
- 2019-10-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks. | Response Rate is defined as combined number of patients with Complete Remission (CR) Complete Remission undetermined (Cru) and Partial Remission (PR) for patients with Burkitt's and Burkitt-like Lymphoma/Leukemia. Response will be measured by CT scans following treatment completion and assessed using Response Criteria for Non-Hodgkin's Lymphoma where: CR=complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu=same as above but allowing for 75% decrease in lymph node masses and indeterminate or normal bone marrow. PR=50% decrease in SPD of the six largest dominant nodes or nodal masses with no increase in size or other nodes, liver, spleen and no new sites of disease. |
| Secondary | Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | At 2 years from treatment initiation Median follow up 34 months (range 15-45) | Overall Survival (OS) of patients with Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen. OS is defined from the first dose of study drug to the time of death for any reason. |
| Secondary | Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) | After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients. | Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months. In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
| Secondary | Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | At 2 years from treatment initiation. Median follow up 34 months (range 15-45) | Progression Free Survival (PFS) will be defined from the first dose of study drug to the first documentation of progressive disease or death for any reason. Patients that are lost to follow-up before progression will be censored at the point of last documentation of not experiencing the event. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks. | One patient was determined not to be evaluable for response as he did not complete 2 cycles that were required per protocol to be evaluable for this outcome measure | percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | At 2 years from treatment initiation Median follow up 34 months (range 15-45) | Evaluable patients for this outcome measure and were reported on together and in stratified group: high-risk and low-risk | percentage of patients alive | NUMBER |
| SECONDARY | Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) | After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients. | All patients that receive at least one dose of study drug are evaluable for this outcome measure | participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | At 2 years from treatment initiation. Median follow up 34 months (range 15-45) | Evaluable patients for this outcome measure and were reported on together and in stratified group: high-risk and low-risk | percentage of patients progression free | NUMBER |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | High Risk - Treated With Alternating R-CODOX-M/R-IVAC | ORR after two cycles of treatment | 100 | percentage of patients | |
| Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | Low Risk - Treatment With 3 Cycles of R-CODOX-M | ORR after two cycles of treatment | 100 | percentage of patients | |
| Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | High Risk - Treated With Alternating R-CODOX-M/R-IVAC | ORR at completion of treatment | 100 | percentage of patients | |
| Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | Low Risk - Treatment With 3 Cycles of R-CODOX-M | ORR at completion of treatment | 100 | percentage of patients | |
| Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | High Risk - Treated With Alternating R-CODOX-M/R-IVAC | 81 | percentage of patients alive | ||
| Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 100 | percentage of patients alive | ||
Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) | High Risk - Treated With Alternating R-CODOX-M/R-IVAC | Anemia : Grade 3 | 13 | participants | |
Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) | Low Risk - Treatment With 3 Cycles of R-CODOX-M | Anemia : Grade 3 | 3 | participants | |
Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) | High Risk - Treated With Alternating R-CODOX-M/R-IVAC | Anemia : Grade 4 | 1 | participants | |
Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) | Low Risk - Treatment With 3 Cycles of R-CODOX-M | Anemia : Grade 4 | 0 | participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment on Study | STARTED | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 20 | |
| Treatment on Study | STARTED | High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles | 5 | |
| Treatment on Study | COMPLETED | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 17 | |
| Treatment on Study | COMPLETED | High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles | 4 | |
| Treatment on Study | NOT COMPLETED | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 3 | |
| Treatment on Study | NOT COMPLETED | High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles | 1 | |
| Follow up for 2 Years | STARTED | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 20 | |
| Follow up for 2 Years | STARTED | High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles | 5 | |
| Follow up for 2 Years | COMPLETED | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 16 | |
| Follow up for 2 Years | COMPLETED | High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events238
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic reaction/ hypersensitivity (including drug fever) | Immune system disorders | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 1 | 20 | |
| other | Allergic reaction/ hypersensitivity (including drug fever) | Immune system disorders | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 0 | 5 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 18 | 20 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 5 | 5 | |
| other | Neutrophils (neutropenia) | Blood and lymphatic system disorders | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 11 | 20 | |
| other | Neutrophils (neutropenia) | Blood and lymphatic system disorders | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 3 | 5 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 20 | 20 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 5 | 5 | |
| other | Lymphopenia | Blood and lymphatic system disorders | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 10 | 20 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 3 | 5 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 4 | 20 |
| Total, all-cause mortality | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 0 | 5 |
| Total, other adverse events | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 20 | 20 |
| Total, other adverse events | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 5 | 5 |
| Total, serious adverse events | High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles | 20 | 20 |
| Total, serious adverse events | Low Risk - Treatment With 3 Cycles of R-CODOX-M | 2 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24146219 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles vs Low Risk - Treatment With 3 Cycles of R-CODOX-M: deaths from any cause | Trial comparisons |
| High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles vs Low Risk - Treatment With 3 Cycles of R-CODOX-M: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00392990
GET https://conductscience.org/api/trials/v1/NCT00392990/results?page=2