Trial Outcomes & Findings for Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL) (NCT NCT00500240)

NCT ID: NCT00500240

Last Updated: 2015-06-03

Results Overview

The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 52 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-06-03

Participant Flow

Recruitment Period: 04/27/2004 through 7/1/2008. All participants recruited at the University of Texas (UT) MD Anderson Cancer Center.

Fifty-two participants were randomized to a conventional treatment arm or an intensive insulin intervention arm. One participant on the conventional control arm was excluded and did not receive allocated intervention.

Participant milestones

Measure	Conventional Care Control Group: Conventional care using blood sugar management with regular human insulin.	Intensive Insulin Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
Overall Study STARTED	25	26
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)

Baseline characteristics by cohort

Measure	Conventional Care n=25 Participants Control Group: Conventional care using blood sugar management with regular human insulin.	Intensive Insulin n=26 Participants Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine	Total n=51 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	57.5 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: There were 51 evaluable participants.

The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.

Outcome measures

Measure	Conventional Care n=25 Participants Control Group - Conventional care using blood sugar management with regular human insulin.	Intensive Insulin n=26 Participants Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
1-Year Overall Survival Rate	80.8 percentage of participants Interval 67.0 to 97.4	63.5 percentage of participants Interval 47.0 to 85.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Care n=8 Deaths Control Group - Conventional care using blood sugar management with regular human insulin.	Intensive Insulin n=10 Deaths Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
Overall Survival	44 Months Interval 2.0 to 66.0	62.2 Months Interval 0.5 to 62.2

PRIMARY outcome

Timeframe: Date of complete remission to disease progression, assessed for approximately 6 years

Population: There were 51 evaluable participants.

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.

Outcome measures

Measure	Conventional Care n=25 Participants Control Group - Conventional care using blood sugar management with regular human insulin.	Intensive Insulin n=26 Participants Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
Progression Free Survival (PFS)	38.8 Months Interval 1.0 to 66.0	24 Months Interval 1.0 to 62.0

Adverse Events

Conventional Care

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Insulin

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Conventional Care n=25 participants at risk Control Group: Conventional care using blood sugar management with regular human insulin.	Intensive Insulin n=26 participants at risk Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
Hepatobiliary disorders Acute Pancreatitis	4.0% 1/25 • Number of events 1 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.	0.00% 0/26 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.
General disorders Pain	0.00% 0/25 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.	7.7% 2/26 • Number of events 2 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.
Infections and infestations Neutropenic Fever	0.00% 0/25 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.	7.7% 2/26 • Number of events 3 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/25 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.	7.7% 2/26 • Number of events 3 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.
General disorders Death	32.0% 8/25 • Number of events 8 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.	38.5% 10/26 • Number of events 10 • Adverse event (AE) collection from identification of high blood sugar levels until completion of chemotherapy (about 8 months). Study period was from enrollment beginning on 4/27/2004 and follow up ending on 1/20/2010.

Other adverse events

Adverse event data not reported

Additional Information

Khanh D Vu, MD/ Associated Professor

UT MD Anderson Cancer Center

Phone: 713-745-4516

Email: eharriso@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place