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

NCT00500240 | Terminated Phase 3 Results

• 1 other identifier: 2004-0107
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia; Lymphoma

Keywords

Acute Lymphocytic Leukemia; Leukemia; Lymphoma; Burkitts Lymphoma; Lymphoblastic Leukemia; Blood Sugar; Hyperglycemia; Insulin Aspart; Insulin Glargine; Hyper-CVAD

Outcome Measures

Primary Outcomes (3)

• 1-Year Overall Survival Rate

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

  1 year

• Overall Survival

  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.

  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

• Progression Free Survival (PFS)

  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.

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

Study Arms (2)

Conventional Care

NO INTERVENTION

Control Group: Conventional care using blood sugar management with regular human insulin.

Intensive Insulin

OTHER

Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine

Drug: Insulin Glargine; Drug: Insulin Aspart

Interventions

Insulin Glargine DRUG

Use of human insulin glargine for slow decrease of blood sugar level over 24 hours.

Intensive Insulin

Insulin Aspart DRUG

Use of human insulin aspart for rapid lowering of the blood glucose level over 24 hours.

Intensive Insulin

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 15 years.
• Previously untreated ALL, Burkitt's lymphoma, or lymphoblastic leukemia receiving induction chemotherapy with hyper-CVAD or variants of the hyper-CVAD regimen.
• Random serum glucose \>/= 180 mg/dL detected during the first 2 cycles of chemotherapy and confirmed with a second measurement.

You may not qualify if:

• History of Type I diabetes mellitus.
• Pregnancy or breast feeding.
• Allergy to insulin or insulin products.
• On-going treatment of steroid-induced hyperglycemia by an endocrinologist and/or general internist.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Vu 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 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center's Website

MeSH Terms

Conditions

Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Hyperglycemia

Interventions

Insulin Glargine; Insulin Aspart

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

Study terminated early due to futility at the pre-determined interim analysis point.

Results Point of Contact

• Title: Khanh D Vu, MD/ Associated Professor
• Organization: UT MD Anderson Cancer Center

eharriso@mdanderson.org

713-745-4516

Study Officials

• Khanh Vu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: April 1, 2004
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 3, 2015
• Results First Posted: August 7, 2014

Record last verified: 2015-06

Locations

US (1)