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Dexamethasone

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Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Methotrexate

Vincristine

Dexamethasone acetate

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Folinic Acid

Folate

Vitamin B9

Complete remission achieved after Induction Phase

Failure to achieve complete remission after the Induction Phase

Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.

Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks

Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (prior to IV).

Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks.

Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.

Methylprednisone

Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.

Hydrocortisone Sodium Succinate

Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.

Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.

6-MP

Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose.

Consolidation II: Intravenously every 3 weeks.

PEG-Asparaginase

Used for PH+ ALL subjects enrolled prior to May 1st 2011 only and is used continuously throughout every phase of treatment.

Imatinib

Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.

Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF

Radiation Therapy

E. coli Asparaginase

Daniel DeAngelo, MD

The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL\>

* This study has several periods of treatment called phases and uses several different drugs in each phase. The drugs may be given by mouth, into a vein, or into the spinal fluid (called intrathecal chemotherapy). In some individuals this treatment helps prevent leukemia cells from coming back in the spinal fluid and brain. Radiation therapy will also be administered as part of this treatment regimen.
* The treatment program consists of 2-different treatment arms with six separate phases of therapy. The phases of treatment are: (1) Steroid prophase (2) Induction (3) Consolidation I (4) Central nervous system (CNS) therapy (5) Consolidation II (6) Continuation.
* The participants treatment arm will depend on the status of their leukemia at the end of the induction therapy (the second phase of treatment). Arm A: all participants who achieve complete remission after Induction and Arm B: all participants who fail to achieve a complete remission after Induction.
* Steroid Prophase: All participants are involved in this treatment phase which consists of two drugs, one given intravenously (IV) and one given intrathecally. This phase lasts 3 days and the purpose is to collect scientific data that might be useful in the future and to see how steroids work in treating leukemia
* Induction: This phase begins immediately after the steroid prophase and lasts about 1 month. Induction is used to cause a remission. Eight drugs are used during this phase of treatment, and administration is either orally, IV or intrathecal. On day 29, participant's bone marrow and peripheral blood counts will be tested. If they have achieved complete remission or partial remission, they will proceed to the next phase of treatment. If they are not in complete remission, they will receive vincristine by IV on days 32, 39 and 46, until complete remission is achieved. If they do not achieve complete or partial remission by day 53 they will be removed from the study.
* Consolidation I: This phase of treatment begins as soon as there is a documented confirmation that the participant's leukemia is either in complete or partial remission. Treatment in this phase lasts about 7 weeks and is intended to further reduce the number of leukemia cells in the body. This consolidation treatment consists of 3 phases: 1A, 1B and 1C. Each phase involves a three week cycle of chemotherapy. Arm A and Arm B will be assigned according to remission status after induction therapy and will determine the order that the participant follows the Consolidation phases.
* Central Nervous System (CNS) Therapy: CNS therapy begins 3 weeks after the end of Consolidation I therapy and should last 3 weeks. Treatment includes a series of lumbar punctures with the administration of anti-leukemia drug as well as oral drugs and IV drugs. Radiation therapy will also be given during this phase of therapy. The purpose of radiation therapy is to prevent leukemia from coming back in the brain. Radiation therapy will be given in either 8 or 10 daily treatments.
* Consolidation II Therapy: This phase begins as soon as CNS therapy ends and lasts about 27-30 weeks. It consists of cycles of chemotherapy repeated every three weeks along with IV PEG-asparaginase administered every 3 weeks. The cycles will be repeated until the participant receives a total of 10 doses of asparaginase.
* Continuation Therapy: This phase begins after the end of the Consolidation II phase. The goal of this phase is to get rid of all leukemia in the body. It consists of cycles of chemotherapy repeated every three weeks and will last until the participant has been in remission for two years.
* During all phases of treatment, participants will have tests and procedures to monitor their health and for research purposes.

ALL Adult Consortium Trial: Adult ALL Trial

Massachusetts General Hospital

Boston Children's Hospital

NCIC Clinical Trials Group

Dana-Farber Cancer Institute

Principal Investigator

Neuroprotective Agents

Everolimus

Prednisone

Prednisolone

Lenograstim

BB 1101

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Mesna

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Adjuvants, Immunologic

Protective Agents

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.

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.

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.

Everolimus (RAD001)

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).

50 mg/m\^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given.

40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days.

600 mg/m\^2 IV continuous infusion daily for 24 hours days 1-3.

200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 IV over 22 hours day 1.

3 gm/m\^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.

Ara-C (Cytarabine)

50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3.

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.

G-CSF

Marina Konopleva, MD, PHD

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:

* On Days 1-3, you will receive cyclophosphamide by vein over 2-3 hours every 12 hours.
* On Days 1-4 and 11-14, you will receive dexamethasone by mouth or by vein. If by vein, the infusion will take a few seconds.
* On Day 4, you will receive doxorubicin over 24 hours through a CVC.
* On Days 4 and 11, you will receive vincristine by vein over 2-3 hours.

Cycles 2, 4, 6, and 8:

During Cycles 2, 4, 6, and 8, you will receive the methotrexate and cytarabine by vein as follows:

* On Day 1, you will receive methotrexate by vein over 24 hours.
* On Day 1, you may receive leucovorin (citrovorum) by vein (over 15 minutes) for 2-3 days. Leucovorin is given to help prevent methotrexate side effects.
* On Days 2-3, you will receive cytarabine by vein over 2 hours every 12 hours.
* On Days 1-3, you will receive methylprednisone over 2 hours every 12 hours for 6 doses.

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:

* You will take 6-mercaptopurine by mouth with water every day.
* You will receive methotrexate by vein (over 2 hours) or mouth every week.
* You will receive vincristine by vein over 30 minutes every 28 days.
* You will take prednisone by mouth for 5 days every month.

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:

* You will have a physical exam.
* Blood (about 8 teaspoons) and urine will be collected for routine tests.
* You will have a bone marrow aspirate.
* You will have a chest X-ray or computed tomography (CT) scan if needed.

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:

* You will have a physical exam.
* Blood (about 8 teaspoons) will be drawn for routine tests.
* You will have a bone marrow aspirate.
* If your doctor thinks it is needed, you will have a chest x-ray or CT scan.

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:

* You will have a physical exam.
* You will have a bone marrow aspirate.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* If your doctor thinks it is needed, you will have a chest x-ray.

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.

RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia

Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)

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.

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.

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.

Novartis

M.D. Anderson Cancer Center

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.

Phase I: RAD001 5 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.

Phase I: RAD001 10 mg + 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.

Phase II: MTD RAD001 + Combination Chemo

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Marina Konopleva, MD, PHD/Professor, Leukemia

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.

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.

Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)

Overall Response Rate (OR) Where OR = CR + CRp + CRi

Complete Remission

Complete Remission without platelet recovery

CR with incomplete blood count recovery

Partial Remission

Nonresponder

Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ALL Adult Consortium Trial: Adult ALL Trial	NCT00476190	Acute Lymphobla...	Doxorubicin Cytarabine Methotrexate Vincristine Cyclophosphamid... Methylprednison... Hydrocortisone ... Dexamethasone 6-MP PEG-Asparaginas... Imatinib Etoposide Radiation Thera... E. coli Asparag...	18 Years - 50 Years	Dana-Farber Cancer Institute
RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia	NCT00968253	Leukemia Acute Lymphocyt...	Everolimus (RAD... Cyclophosphamid... Vincristine Doxorubicin Dexamethasone Mesna Methotrexate Ara-C (Cytarabi... Methylprednison... G-CSF	10 Years -	M.D. Anderson Cancer Center
ALL Adult Consortium Trial: Adult ALL Trial	NCT00476190	Acute Lymphobla...	Doxorubicin Cytarabine Methotrexate Vincristine Cyclophosphamid... Methylprednison... Hydrocortisone ... Dexamethasone 6-MP PEG-Asparaginas... Imatinib Etoposide Radiation Thera... E. coli Asparag...	18 Years - 50 Years	Dana-Farber Cancer Institute

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