Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
2 other identifiers
interventional
56
1 country
1
Brief 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. The safety of the combined treatment will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
May 16, 2018
CompletedMay 16, 2018
April 1, 2018
13.2 years
April 28, 2008
October 19, 2016
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Ă— 10\^9/L, a platelet count ≥100 Ă— 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 Ă— 10\^9/L. Partial remission (PR) was defined as a bone marrow with \>5% and \<25% blasts with a granulocyte count of ≥1.0 Ă— 109/L and a platelet count of ≥100 Ă— 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.
After two 21-day courses, response to treatment checked for Complete Remission (CR)
Other Outcomes (1)
Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR)
After two 21-day courses, response to treatment checked for Complete Remission (CR)
Study Arms (1)
Hyper-CVAD
EXPERIMENTALHyper-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.
Interventions
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.
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).
50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses)
40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses)
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).
200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \) N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naval Daver, Assistant Professor, Leukemia
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Susan O'Brien, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2008
First Posted
May 1, 2008
Study Start
August 1, 2002
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
May 16, 2018
Results First Posted
May 16, 2018
Record last verified: 2018-04