Phase 2
Completed N=220
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT00671658 ↗Enrolled (actual)
220
Serious AEs
28.4%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With a Response — 198; 3; 4 Participants
Summary
The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Response |
198; 3; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed, previously untreated Acute Lymphoblastic Leukemia (ALL) or lymphoblastic lymphoma, or having achieved Complete Remission (CR) with one course of induction chemotherapy.
- Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.
- All ages are eligible.
- Zubrod performance less than or equal to 3
- 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).
- Adequate cardiac function as assessed by history and physical examination.
- No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT00671658). 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.