Clinical trial · Interventional
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia
NCT00671658CI-TRIAL-00048611completedPhase 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 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.
Conditions
Conditions (2)
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 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (CTX) | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate (MTX) | Drug | Methotrexate | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| Pegylated asparaginase |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HYPER-CVAD
- description
- Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m\^2 IV, Doxorubicin 50 mg/m\^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m\^2 IV followed by 800 mg/m\^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m\^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m2 a day IV, Pegylated asparaginase 2000 International units/m\^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hrs after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide (CTX)
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dexamethasone
- Drug: Methotrexate (MTX)
- Drug: Cytarabine
- Drug: G-CSF
- Drug: Mesna
- Drug: Pegylated asparaginase
- Drug: Pegfilgrastim
- Drug: Solumedrol
Primary outcomes (1)
- measure
- Number of Participants With a Response
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed, previously untreated Acute Lymphoblastic Leukemia (ALL) or lymphoblastic lymphoma, or having achieved Complete Remission (CR) with one course of induction chemotherapy. 2. Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately. 3. All ages are eligible. 4. Zubrod performance less than or equal to 3 5. 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). 6. Adequate cardiac function as assessed by history and physical examination. 7. No active co-existing malignancy with life expectancy less than 12 months due to that malignancy. Exclusion Criteria: 1\) N/A
References
Publications (0)
Data not yet available
No reference posted for this study.