Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
1 other identifier
interventional
90
1 country
1
Brief Summary
The goal of this clinical research study is to learn if a special combination of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety of this therapy will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2003
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
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
August 23, 2011
CompletedFebruary 20, 2012
February 1, 2012
7.6 years
April 29, 2009
July 25, 2011
February 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete Remission
Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 \* 10\^9/L and a platelet count of ≥ 100 \* 10\^9/L with complete resolution of all sites of extramedullary disease required.
Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.
Study Arms (1)
Augmented Hyper-CVAD
EXPERIMENTALHyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
Interventions
300 mg/m\^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of
2 mg by vein (IV) weekly for 3: Days 1, 8, 15
80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18
10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours
200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1
3 gm/m\^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.
2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses
Eligibility Criteria
You may qualify if:
- Previously treated acute lymphoblastic leukemia (ALL) (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory;
- No age restrictions;
- Zubrod performance status \</= 3;
- Adequate liver (bilirubin \</= 3mg/dl unless considered due to tumor) and renal function (creatinine \</= 3mg/dl unless considered due to tumor);
- Adequate cardiac function (New York Heart Association (NYHA) \< III as assessed by history and physical examination)
You may not qualify if:
- Not Applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Enzon Pharmaceuticals, Inc.collaborator
Study Sites (1)
UT MD 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
- Stefan Fader, M.D./Associate Professor
- Organization
- The University of Texas M. D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan F. Faderl, M.D.
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 29, 2009
First Posted
April 30, 2009
Study Start
June 1, 2003
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 20, 2012
Results First Posted
August 23, 2011
Record last verified: 2012-02