Phase 2
N=90
Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00890656 ↗Enrolled (actual)
90
Serious AEs
36.7%
Results posted
Aug 2011
Primary outcome: Primary: Number of Participants With Complete Remission — 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (CTX) (Drug); Vincristine (Drug); Doxorubicin (Drug); Decadron (Drug); G-CSF (Drug); Methotrexate (MTX) (Drug); Ara-C (Drug); Pegaspargase (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Remission |
41 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Not Applicable
Data sourced from ClinicalTrials.gov (NCT00890656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.