Phase 2
Completed N=90
Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Source: ClinicalTrials.gov NCT00890656 ↗Enrolled (actual)
90
Serious AEs
36.7%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Complete Remission — 41 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Remission |
41 | — |
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. Informational only — not medical advice.