Trial · NCT00500240
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)
NCT00500240, Phase 3, Terminated, M.D. Anderson Cancer Center; results first posted 2014-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL). Trials, record NCT00500240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500240
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)
- NCT number
- NCT00500240
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia, Lymphoma
- Interventions
- Insulin Glargine, Insulin Aspart
- First posted
- 2007-07-12
- Last updated
- 2015-06-03
- Results first posted
- 2014-08-07
- Limitations and caveats
- Study terminated early due to futility at the pre-determined interim analysis point.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-Year Overall Survival Rate | 1 year | The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months. |
| Primary | Overall Survival | Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years | Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up. |
| Primary | Progression Free Survival (PFS) | Date of complete remission to disease progression, assessed for approximately 6 years | PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count \>1.0 × 10\^9/L, platelet count \>100 × 10\^9/L, no abnormal peripheral blasts, and \<5% blasts in normocellular or hypercellular bone marrow. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 1-Year Overall Survival Rate | 1 year | There were 51 evaluable participants. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival | Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years | Months | MEDIAN | |
| PRIMARY | Progression Free Survival (PFS) | Date of complete remission to disease progression, assessed for approximately 6 years | There were 51 evaluable participants. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 1-Year Overall Survival Rate | Conventional Care | 80.8 | 95% Confidence Interval 67 to 97.4 | percentage of participants | |
| 1-Year Overall Survival Rate | Intensive Insulin | 63.5 | 95% Confidence Interval 47 to 85.8 | percentage of participants | |
| Overall Survival | Conventional Care | 44 | Full Range 2 to 66 | Months | |
| Overall Survival | Intervention Group | 62.2 | Full Range 0.5 to 62.2 | Months | |
| Progression Free Survival (PFS) | Conventional Care | 38.8 | Full Range 1 to 66 | Months | |
| Progression Free Survival (PFS) | Intensive Insulin | 24 | Full Range 1 to 62 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Conventional Care | 25 | |
| Overall Study | STARTED | Intensive Insulin | 26 | |
| Overall Study | COMPLETED | Conventional Care | 25 | |
| Overall Study | COMPLETED | Intensive Insulin | 26 | |
| Overall Study | NOT COMPLETED | Conventional Care | 0 | |
| Overall Study | NOT COMPLETED | Intensive Insulin | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute Pancreatitis | Hepatobiliary disorders | Conventional Care | 1 | 25 | 1 |
| serious | Acute Pancreatitis | Hepatobiliary disorders | Intensive Insulin | 0 | 26 | 0 |
| serious | Pain | General disorders | Conventional Care | 0 | 25 | 0 |
| serious | Pain | General disorders | Intensive Insulin | 2 | 26 | 2 |
| serious | Neutropenic Fever | Infections and infestations | Conventional Care | 0 | 25 | 0 |
| serious | Neutropenic Fever | Infections and infestations | Intensive Insulin | 2 | 26 | 3 |
| serious | Hypoglycemia | Metabolism and nutrition disorders | Conventional Care | 0 | 25 | 0 |
| serious | Hypoglycemia | Metabolism and nutrition disorders | Intensive Insulin | 2 | 26 | 3 |
| serious | Death | General disorders | Conventional Care | 8 | 25 | 8 |
| serious | Death | General disorders | Intensive Insulin | 10 | 26 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conventional Care | ||
| Total, all-cause mortality | Intensive Insulin | ||
| Total, other adverse events | Conventional Care | 0 | 25 |
| Total, other adverse events | Intensive Insulin | 0 | 26 |
| Total, serious adverse events | Conventional Care | 9 | 25 |
| Total, serious adverse events | Intensive Insulin | 10 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22658895 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Conventional Care vs Intensive Insulin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00500240
GET https://conductscience.org/api/trials/v1/NCT00500240/registered