Clinical trial · Interventional
Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
NCT00890656CI-TRIAL-00006296completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C | Drug | Cytarabine | ALIAS |
| Cyclophosphamide (CTX) | Drug | Cyclophosphamide | ALIAS |
| Decadron | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Methotrexate (MTX) | Drug | Methotrexate | ALIAS |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Augmented Hyper-CVAD
- description
- Hyper-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.
- interventionNames
- Drug: Cyclophosphamide (CTX)
- Drug: Vincristine
- Drug: Doxorubicin
- Drug: Decadron
- Drug: G-CSF
- Drug: Methotrexate (MTX)
- Drug: Ara-C
- Drug: Pegaspargase
Primary outcomes (1)
- measure
- Number of Participants With Complete Remission
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.