MDACC Study Summary 2004-0107

Study Summary
No. 2004-0107:.......Endocrine; Hematologic Disorder; Leukemia; Lymphoma......Khanh Vu......General Internal Medicine/Ambulatory Treatment & Emergency Care

Study Summary Title



Study Summary Number:	2004-0107

Study Title:	Effect of tight control of blood glucose during Hyper-CVAD chemotherapy for acute lymphocytic leukemia

Physician

New Patient Referral



Name:	Khanh Vu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	General Internal Medicine/Ambulatory Treatment & Emergency Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0655 Contact us about clinical trials

General Information



Disease Group:	Endocrine Hematologic Disorder Leukemia Lymphoma	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Routine clinic follow ups and scheduled admissions will be determined by the clinic leukemia physician. Pts in the interventional group will follow up with the PI/co-PIs about every 2 months, which will be coordinated with routine clinic visits.

Treatment Agents:	Insulin aspart Insulin Glargine	Home Care:	All the insulin treatments can be given at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	This is mainly an outpatient based therapy. Our treatment will not require additional hospitalizations.


Description/ Intervention:	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.

Study Objectives / Outcomes

The primary objective of this study is:
1. To determine if aggressive management of hyperglycemia results in longer overall survival in patients with ALL, Burkitts lymphoma, or lymphoblastic lymphoma treated with HyperCVAD or variants of the HyperCVAD regimen.

The secondary objectives are:
1. To determine if aggressive management of hyperglycemia results in longer complete remission duration (CRD).
2. To determine if aggressive management of hyperglycemia results in a higher complete response rate.
3. To determine if aggressive management of hyperglycemia results in a lower rate of infectious complications.
4. To determine if aggressive management of hyperglycemia results in fewer and shorter hospitalizations and fewer intensive care unit admissions.
5. To determine if high baseline expression of Akt and glucose transporters in leukemic blasts in patients with poor controlled hyperglycemia correlates with in vivo responses to chemotherapy.
6. Characterize effects of hyperglycemia in vivo on chemosensitivity of leukemic blasts exposed to dexamethasone and doxorubicin ex vivo, and correlate these effects with Akt activation.

Study Status Information



Study Activation / Registration Date:	04/23/2004

IRB Review and Approval Date:	03/17/2004

Study Type:

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Age >/= 15 years.

2) Previously untreated ALL, Burkitt's lymphoma, lymphoblastic leukemia, or biphenotypic acute leukemia patients 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.

Links

Registration Number: NCT00500240
Study Information on Clinical Trials Registry (clinicaltrials.gov)