Clinical trial · Interventional
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia
NCT00500240CI-TRIAL-00018136terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to futility.
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if intense management and control of blood sugar levels during treatment for acute lymphocytic leukemia, Burkitts lymphoma, or lymphoblastic lymphoma will result in decreased risk of relapse, fewer complications, and/or longer survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Insulin Aspart | Drug | — | UNRESOLVED |
| Insulin Glargine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional Care
- description
- Control Group: Conventional care using blood sugar management with regular human insulin.
- type
- OTHER
- label
- Intensive Insulin
- description
- Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
- interventionNames
- Drug: Insulin Glargine
- Drug: Insulin Aspart
Primary outcomes (3)
- measure
- 1-Year Overall Survival Rate
- timeFrame
- 1 year
- description
- The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>/= 15 years. 2. Previously untreated ALL, Burkitt's lymphoma, or lymphoblastic leukemia receiving induction chemotherapy with hyper-CVAD or variants of the hyper-CVAD regimen. 3. Random serum glucose \>/= 180 mg/dL detected during the first 2 cycles of chemotherapy and confirmed with a second measurement. Exclusion Criteria: 1. History of Type I diabetes mellitus. 2. Pregnancy or breast feeding. 3. Allergy to insulin or insulin products. 4. On-going treatment of steroid-induced hyperglycemia by an endocrinologist and/or general internist.
References
Publications (1)
- DERIVEDVu K, Busaidy N, Cabanillas ME, Konopleva M, Faderl S, Thomas DA, O'Brien S, Broglio K, Ensor J, Escalante C, Andreeff M, Kantarjian H, Lavis V, Yeung SC. A randomized controlled trial of an intensive insulin regimen in patients with hyperglycemic acute lymphoblastic leukemia. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):355-62. doi: 10.1016/j.clml.2012.05.004. Epub 2012 Jun 1. PMID 22658895