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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01814 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL.
The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.
The Study Drugs:
Everolimus is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.
You will receive everolimus with 2 different chemotherapy combinations during alternating cycles. This means that you will receive 1 combination on Cycles 1, 3, 5, and 7 and the other combination during Cycles 2, 4, 6, and 8.
The first chemotherapy regimen is called hyper-CVAD. Hyper-CVAD includes cyclophosphamide, vincristine, Adriamycin (doxorubicin), and dexamethasone. This combination is designed to kill leukemia cells.
The other chemotherapy regimen includes the drugs methotrexate and ara-C (cytarabine). This combination is also designed to kill leukemia cells.
Study Groups and Everolimus Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 3 groups of 3-6 participants will be enrolled in the Phase I portion of the study, and up to 30 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of everolimus you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of everolimus. Each new group will receive a higher dose of everolimus than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of everolimus is found.
If you are enrolled in Phase II, you will receive everolimus at the highest dose that was tolerated in the Phase I portion.
In this study, everolimus is the only study drug where different dose levels are being tested and compared. All other drugs will be given at the same dose level.
Central Venous Catheter (CVC):
If you do not already have a CVC, you will have a CVC placed. A CVC is a plastic tube usually placed under the collarbone. You will sign a separate consent for this procedure. Some of the study drugs will be given through the CVC.
Everolimus Administration:
During all cycles, you will take everolimus once a day followed by a big glass of water. The tablets must not be chewed, broken or crushed. You may either take everolimus on an empty stomach or after a low fat meal. Taking everolimus after large, fatty meals is not advised because it will lower the amount of everolimus your body absorbs. Some examples of a low fat meal include: cereal with fat free milk, muffin/bagel with fat free spread, fruit salad, and so on. Always follow the instructions for use of everolimus given to you by your study doctor. Your first dose of everolimus will occur 1 day before you begin receiving chemotherapy.
Do not miss any tablets/capsules. You should take everolimus about the same time each day preferably in the morning.
If your study doctor thinks it is needed or if you experience severe side effects, everolimus may be stopped and then started again with a lower dose or may be stopped completely.
Chemotherapy Administration:
Each cycle will last about 21 days. The timing of each new cycle will depend on when your blood counts recover.
Cycles 1, 3, 5, and 7:
During Cycles 1, 3, 5, and 7, you will receive hyper-CVAD. The drugs will be given at the following times:
Cycles 2, 4, 6, and 8:
During Cycles 2, 4, 6, and 8, you will receive the methotrexate and cytarabine by vein as follows:
Cycles 1-8:
You will also receive either Neupogen (filgrastim) or pegfilgrastim to help your bone marrow recover from chemotherapy. Filgrastim or pegfilgrastim will be injected under the skin within 72 hours after each cycle of chemotherapy. If you receive filgrastim, it will be given daily until your counts recover. If you receive pegfilgrastim, it will be given 1 time.
You will also receive small doses of methotrexate and Ara-C, one after the other, by a spinal tap to help prevent the disease from coming back in the fluid surrounding your brain during each cycle. During a spinal tap, a doctor or technician inserts a needle through the skin and the soft tissues of the lower back to reach a pocket of fluid that is part of the fluid space that surrounds the brain and the spinal cord. Once the fluid space is reached, chemotherapy drugs can be administered. The procedure is done under local anesthesia. An Ommaya reservoir (which holds the drugs being given) may also be implanted surgically if you have difficulty with the spinal treatments. An Ommaya reservoir is a tube inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain. You will be asked to sign a separate consent form for this procedure. The number of doses you receive will depend on how many doses the study doctor thinks are needed. If you start with leukemia in the brain, it will be given 2 times a week until there is no leukemia present and then 1 time a week for 4 weeks. Sometimes, a sample of the spinal fluid collected from the spinal taps may be tested to look for leukemia cells.
Maintenance Chemotherapy:
After you have completed 8 cycles, you will begin monthly (about every 28 days, depending on your blood cell count recovery) maintenance chemotherapy for about the next 24 months. You will take the following drugs:
Study Visits:
During Cycle 1, blood (about 1 tablespoon) will be drawn for routine tests 1-3 times every week. During Cycles 2-8, blood (about 1 tablespoon) will be drawn for routine tests every 1-4 weeks.
During Cycles 1 and 2, you will have physical exam every week. After Cycle 2, you will have a physical exam every 3-4 weeks.
At Weeks 2 and 3 of Cycle 1, you will have a bone marrow aspirate to check for response. Depending on the results of the sample, this will be repeated every 1-2 weeks.
At Week 4-6 of Cycle 1, you will have a chest x-ray.
After Cycle 2 is over, the following tests and procedures will be performed:
If you had a positive hepatitis B test at screening, every month, blood (about 1 tablespoon) will be drawn to test the level of hepatitis B virus in your blood.
If your have risk factors and/or a positive Hepatitis C test results at screening, every month, blood (about 1 tablespoon) will be drawn to test the level of Hepatitis C virus in your blood.
Length of Study:
You may receive up to 32 cycles of study drugs. You will be taken off study early if the disease gets worse, your doctor decides it is in your best interest to stop, or you have intolerable side effects.
End-of-Study Visit:
After your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
Follow-up Visits:
You will have follow-up visits every 3 to 6 months. At these visits, the following tests and procedures will be performed:
This is an investigational study. All the chemotherapy drugs used on this study are FDA approved and commercially available for treating ALL. Everolimus is FDA approved and commercially available for the treatment of certain types of breast cancer. At this time, the combination is only being used in research.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: RAD001 + Combination Chemo | Experimental | Optimal dose finding of Everolimus (RAD001) beginning dose 5 mg + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Cycles 1, 3, 5, & 7 and Methotrexate & Cytarabine (Ara-C) during Cycles 2, 4, 6, & 8. First chemotherapy combination Hyper-CVAD = Cyclophosphamide, Vincristine, Adriamycin (doxorubicin), and Dexamethasone; Second chemotherapy combination Methotrexate and Ara-C. |
|
| Phase II: MTD RAD001 + Combination Chemo | Experimental | MTD dose of Everolimus + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Cycles 1, 3, 5, & 7 and Methotrexate & Ara-C during Cycles 2, 4, 6, & 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus (RAD001) | Drug | Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT) | The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study. A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs. | Following first two dose cycles (21 days/each), up to 42 days |
| Overall Response Rate (OR) Where OR = CR + CRp + CRi | Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. | 8 courses of treatment, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg) | Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Konopleva, MD, PHD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: November 18, 2009 to March 21, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: RAD001 5 mg + Combination Chemo | Everolimus (RAD001) beginning oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3. Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cyclophosphamide | Drug | 300 mg/m^2 intravenous (IV) over 3 hours every 12 hours x 6 doses on Days 1, 2, 3 (total dose 1800 mg/m2). |
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| Vincristine | Drug | 2 mg IV on Day 4 and Day 11 ± 2 days. |
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| Doxorubicin | Drug | 50 mg/m^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given. |
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| Dexamethasone | Drug | 40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days. |
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| Mesna | Drug | 600 mg/m^2 IV continuous infusion daily for 24 hours days 1-3. |
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| Methotrexate | Drug | 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours day 1. |
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| Ara-C (Cytarabine) | Drug | 3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3. |
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| Methylprednisone | Drug | 50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3. |
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| G-CSF | Drug | 10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF. |
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| Up to 20 cycles of study drugs (21 day cycles) or till disease progression |
| FG001 | Phase I: RAD001 10 mg + Combination Chemo | RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3. Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher. |
| FG002 | Phase II: MTD RAD001 + Combination Chemo | RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3. Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: RAD001 5 mg + Combination Chemo | RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. |
| BG001 | Phase I: RAD001 10 mg + Combination Chemo | RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. |
| BG002 | Phase II: MTD RAD001 + Combination Chemo | RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT) | The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study. A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs. | Maximum tolerated dose was an outcome measure for the phase I portion of this study only. MTD was already established, therefore, not analyzed on the participants for the phase II portion of this study. | Posted | Count of Participants | Participants | Following first two dose cycles (21 days/each), up to 42 days |
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| Primary | Overall Response Rate (OR) Where OR = CR + CRp + CRi | Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. | Posted | Number | percentage of participants | 8 courses of treatment, up to 24 weeks |
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| Secondary | Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg) | Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. | Posted | Number | participants | Up to 20 cycles of study drugs (21 day cycles) or till disease progression |
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Adverse event collection for 8 courses of trial (21 day course), up to 24 weeks; SAEs reported from time consent is signed, during the course of treatment and within 30 days after the last day of active treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: RAD001 5 mg + Combination Chemo | RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. | 1 | 3 | 3 | 3 | ||
| EG001 | Phase I: RAD001 10 mg + Combination Chemo | RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. | 7 | 9 | 9 | 9 | ||
| EG002 | Phase II: MTD RAD001 + Combination Chemo | RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. | 11 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Neutropenic Fever | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Chest Pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Septic Shock | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection - E Coli Bacterium | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Multi-Organ Failure | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pleural effusions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Abdominal pain, Bladder Spasms |
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| Mucositis/Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Bilirubin increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Bladder hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Blood glucose increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Blood/Bone Marrow (Other) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Epistaxis |
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| Cardiac General (Other) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | cardiomyopathy, tachycardia |
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| Chest pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Constitutional Symptoms (Other) | General disorders | CTCAE (3.0) | Systematic Assessment | sore mouth |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dental prosthesis, soreness | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Edema limbs | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemoglobin urine positive | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemorrhage/Bleeding (Other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hiccough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection (Other) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Bacteria, Acremonium fungemia |
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| Infection (Other) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | ESCHERICHIA COLI, STENOTROPHOMONAS, HERPES |
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| Infectious colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Metabolic/Laboratory (Other) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Elevated amylase and lipase |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal (Other) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Bilateral Edema |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (Other) | General disorders | CTCAE (3.0) | Systematic Assessment | Left Flank |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| HYPERMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marina Konopleva, MD, PHD/Professor, Leukemia | The University of Texas (UT) MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D004317 | Doxorubicin |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D015080 | Mesna |
| D008727 | Methotrexate |
| D003561 | Cytarabine |
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D008776 | Methylprednisolone Hemisuccinate |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011239 | Prednisolone |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Phase II: MTD RAD001 + Combination Chemo |
RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. |
|
|
| OG002 | Phase II: MTD RAD001 + Combination Chemo | RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. |
|
|