Neoplasms

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Lymphoma

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Leukemia, Lymphoid

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Hyperglycemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

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Acute Graft Versus Host Disease

Hypoglycemic Agents

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Micronutrients

Insulin

Insulin, Globin Zinc

Insulin Aspart

Insulin Glargine

Zinc

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

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

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

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

Khanh Vu, MD

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.

High blood sugar is a common side effect of treatment for certain types of cancer.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive blood sugar management with regular human insulin. Participants in the other group will receive more intense management with two newer forms of human insulin - insulin aspart, for rapid lowering of the blood glucose and insulin glargine for the slow decrease of blood sugar level over 24 hours.

You will receive additional blood tests (about 1 tablespoon each) at the time of entry on the study and after about every 2 to 4 courses of chemotherapy while on the study. These blood tests help better define the severity of your high blood sugar and your body's ability to metabolize sugar. Any bone marrow and blood samples that were collected before your therapy for your leukemia may be used for lab tests to measure markers of glucose metabolism in the blood. You will not be required to have a bone marrow biopsy after enrollment on study.

While in the hospital receiving chemotherapy, you will have your blood sugar checked 3 to 4 times a day. To check your blood sugar level, you, your nurse, or a laboratory technician will prick your finger with a small needle and place a small drop of blood on a test strip. If your blood sugar is high, you will be given the appropriate amount of insulin.

Before you begin out-patient insulin treatment, a research nurse, doctor, or diabetes educator will watch how you and/or your caregiver administer your insulin shots, to make sure that it is done correctly and safely. Once you leave the hospital, you will be required to check your own blood sugar 3 times a day and take insulin (either yourself or with the help of a health provider) up to 4 times a day while on steroid therapy and for 2 days after receiving steroids. On all other days you will be required to check your blood glucose once or twice a day and administer insulin 1 - 3 times daily. You will also need to speak with a nurse by phone every 1-3 days for review of blood sugar measurements and possible adjustment of the dose of insulin you must take.

You will remain on the study from the time you are found to have high blood sugar levels until completion of your chemotherapy (about 8 months for most patients). You may be taken off this study at any time if you find that you are unable or unwilling to monitor your glucose or receive insulin shots at home.

You will be followed for high blood sugar levels while you are receiving treatment with Hyper-CVAD chemotherapy regimen (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating cycles with methotrexate, cytarabine, methylprednisolone). If you continue to have high blood sugar after completion of this treatment, you will have continued follow-up either with your primary physician at home or if you choose, in the Internal Medicine Clinic at M. D. Anderson.

This is an investigational study. All of the insulin used in this study is FDA approved for the treatment of high blood sugar and commercially available. A total of up to 114 patients will take part in this study. All will be enrolled at M. D. Anderson.

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

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

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.

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.

Novo Nordisk A/S

M.D. Anderson Cancer Center

Conventional Care

Intensive Insulin

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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

Khanh D Vu, MD/ Associated Professor

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

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

1-Year Overall Survival Rate

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

Intense blood sugar management with Insulin Aspart + Insulin Glargine

Intervention Group

Overall Survival

Progression Free Survival (PFS)

Overall Study

Phase II - Aggressive NHL: Diffuse Large B Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Transformed Large Cell Lymphoma, and Follicular Lymphoma (FL) grade 3b Group

Participants take TAK-228 1 time every day of a 28 day cycle.

Treatment continues until progression of disease occurs, or a maximum of 12 months of treatment.

Participant checks blood sugar every day before TAK-228 dose.

Phase II - Indolent NHL: Follicular Lymphoma (FL) grade 1-3a, Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL) Group

Participants take TAK-228 1 time every day of a 28 day cycle.

Treatment continues until progression of disease occurs, or a maximum of 12 months of treatment.

Participant checks blood sugar every day before TAK-228 dose.

Phase II - Hodgkin Lymphoma Group

Participants take TAK-228 1 time every day of a 28 day cycle.

Treatment continues until progression of disease occurs, or a maximum of 12 months of treatment.

Participant checks blood sugar every day before TAK-228 dose.

Starting dose of TAK228: 3 mg by mouth every day of a 28 day cycle.

TAK228

Participant given a glucometer to check pre-dose blood sugar levels at home every day.

Blood Sugar Testing

Jason R. Westin, MD

The goal of this clinical research study is to learn if TAK-228 can help to control relapsed lymphoma. The safety of this drug will also be studied.

Study Drug Administration:

If you are found to be eligible for this study, you will begin taking capsules of TAK-228 in 28-day cycles. You will take the drug 1 time every day at about the same time. You should take the drug with about a cup (8 ounces) of water after eating a light meal. You should fast for 2 hours before and 1 hour after each dose.

If you vomit or have other digestive side effects that prevent you from taking a dose, that dose should be skipped. If you vomit up a dose, that dose should not be retaken. In both cases, wait until the next day to take another dose. In no case should you double or repeat a dose. You should record any vomiting in the dose diary the study staff provides you with.

Study Visits:

Within 3 days before you start taking TAK-228, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

On Day 1 of each cycle:

* You will have a physical exam.
* Blood (about 2-3 tablespoons) will be drawn for routine tests. You must fast for 4 hours before this blood draw. Some of these draws will be used for a diabetes test. If you can become pregnant, part of this sample will be used for a pregnancy test.
* Blood (about 2 teaspoons) will be drawn for biomarker testing (Cycles 1 and 2 only).
* You will have an EKG (within 3 days of each cycle after Cycle 1).

On Days 8 and 22 of Cycle 1, you will have a physical exam.

On Day 15 of Cycle 1:

* You will have a physical exam
* Blood (about 2-3 tablespoons) will be drawn for routine tests.

Within 5 days before Day 1 of Cycle 3, then every even-numbered cycle after that (Cycles 4, 6, 8, and so on), you will have CT scans, chest x-rays, and a bone marrow biopsy/aspiration to check the status of the disease.

If the study doctor thinks it is in your best interest, you will have PET/CT scans every 2 cycles to check the status of the disease.

Blood Sugar Testing:

You will be given a glucometer to check your pre-dose blood sugar levels at home every day. The study staff will teach you how to use the glucometer and what an abnormal reading looks like. You must tell the study staff right away if you have any abnormal readings. The frequency of in-home fasting glucose testing may be reduced to once weekly if the doctor thinks it is needed.

Length of Study:

You may continue to receive the study drug for up to 12 cycles. You will no longer be able to take the drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up phone calls have finished.

End-of-Treatment Visits:

About 1 week after you stop taking the study drug:

* You will have a physical exam
* Blood (about 2-3 tablespoons) will be drawn for routine tests and to test for diabetes. This will include a pregnancy test if you are able to become pregnant.
* You will have an EKG.

About 2 weeks after you stop taking the study drug, you will have CT scans and chest x-rays to check the status of the disease. If the study doctor thinks it is needed, you will also have a bone marrow biopsy/aspiration to check the status of the disease.

Within 2 weeks after you stop taking the study drug, blood (about 2 teaspoons) will be drawn for biomarker testing.

This is an investigational study. TAK-228 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can describe how the study drug is designed to work.

Up to 75 participants will be enrolled in this study. All will take part at MD Anderson.

Phase II Study of TAK228 in Relapsed Lymphoma

Assessed with reverse phase protein arrays after exposure to TAK228,

RA was defined by Lugano Criteria \& based on CT scans obtained at screening \& after completion of every 2 cycles of therapy. Complete Radiographic Response Target Nodes must regress to \<=1.5cm in longest dimension,No extralymphatic sites of disease. PR \>=50% decrease in sum of the product of diameters of up to 6 target measurable nodes and extranodal sites. When a lesion is too small to measure on CT, 5 mmx5mm is assigned. When not visible on CT, assign 0x0 mm. For a node 5mmx5mm use actual measurement. SD\< 50% decrease in sum of the product of diameters of up to 6 target measurable nodes \& extranodal sites, no criteria for disease progression are met. Progressive disease requires one of the following:An individual node must be abnormal with: LDi 1.5cm \& Increase by 50% from PPD nadir \& an increase in LDi or SDi from nadir 0.5cm for lesions 2cm,1cm for lesions 2cm. In case of splenomegaly, the splenic length must increase by \>=50% of the extent of its prior increase beyond baseline.

Progression free survival, duration of response and overall survival analysis could not be properly evaluated due to patients being taken off study early due to progression of disease but safety and tolerability were reported through safety event reports, please see AEs-serious and non-serious section for this.

Takeda

Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.

Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b

Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr

Indolent NHL:FL grade1-3a,SLL,MZL

Hodgkin Lymphoma

Age, Categorical

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Westin (Principal Investigator) was only participating in the DLBCL arm.

Dr. Jason R. Westin/Lymphoma/Myeloma

No analysis could be performed due to 2 participants failed screening and 2 participants disease progressed before analysis could be performed

Response Assessment (RA)

Adverse events were evaluated for the time patients were on study however due to early progression of disease, patients did not finish the treatment and adverse events reported were not conclusive of toxicity related to drug. Updated to two participants for the secondary outcome.

Number of Participants With Adverse Events

Exploratory objective was not analyzed because patients came off study before it could be analyzed, no data were collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)	NCT00500240	Leukemia Lymphoma	Insulin Glargin... Insulin Aspart	15 Years -	M.D. Anderson Cancer Center
Phase II Study of TAK228 in Relapsed Lymphoma	NCT02727777	Lymphoma	TAK228 Blood Sugar Tes...	18 Years -	M.D. Anderson Cancer Center
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)	NCT00500240	Leukemia Lymphoma	Insulin Glargin... Insulin Aspart	15 Years -	M.D. Anderson Cancer Center
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)	NCT00500240	Leukemia Lymphoma	Insulin Glargin... Insulin Aspart	15 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for blood sugar

Every month we try and update this database with for blood sugar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for blood sugar

Every month we try and update this database with for blood sugar cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for blood sugar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.