Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Peripheral T-cell Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Etoposide

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Cyclophosphamide

Methotrexate

Sirolimus

Etoposide phosphate

Temsirolimus

MTOR Inhibitors

Hydrocortisone-17-butyrate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

This is the starting dose of temsirolimus at 7.5 mg/m\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m\^2) and cyclophosphamide (440 mg/m\^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.

If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m\^2) and cyclophosphamide (440 mg/m\^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.

If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m\^2) and cyclophosphamide (440 mg/m\^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.

If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m\^2) and cyclophosphamide (440 mg/m\^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4.

Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

PATIENTS WITH CNS 1 COURSES 2, 4, 6, 8: Give intrathecally to patients who were CNS1 at study entry day 1 of each course at the doses listed below.

* Age 1 - 1.99 give 8 mg of methotrexate
* Age 2 - 2.99 give10 mg of methotrexate
* Age 3 - 8.99 give 12 mg of methotrexate
* Age ≥ 9 give 15 mg of methotrexate

PATIENTS WITH CNS 2 or 3 DISEASE

-COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.

COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.

* 8 mg for patients age 1-1.99
* 10 mg for patients age 2-2.99
* 12 mg for patients 3-8.99 years of age
* 15 mg for patients \>9 years of age

Given with Methotrexate and Cytarabine for patients with CNS 2 or 3 disease.

COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.

COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.

* 8 mg for patients age 1-1.99
* 10 mg for patients age 2-2.99
* 12 mg for patients 3-8.99 years of age
* 15 mg for patients \>9 years of age

For Patients who are CNS1 COURSE 1: Give intrathecally to patients with CNS1 disease at the dose defined by age below on day 1 of course 1 if no other IT was given within 1 week of day 1 of course 1

* Age 1 - 1.99 give 30 mg of Cytarabine
* Age 2 - 2.99 give 50mg of Cytarabine
* Age ≥ 3 give 70 mg of Cytabine

For Patients with CNS 2 or 3 Disease COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 1 if no other IT chemotherapy given within 1 week of day 1 of course 1. Then give weekly until the patient is CNS 1 or 2 (investigator discretion). No more than 5 weekly doses to be given in cycle 1.

COURSES 2-8: Give intrathecally to patients who were CNS 2or 3 at study entry on day 1 of each course.

* 16 mg for patients age 1-1.99
* 20 mg for patients age 2-2.99
* 24 mg for patients 3-8.99 years of age
* 30 mg for patients \>9 years of age

Susan Rheingold, MD

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

Studies have shown that mTOR inhibitors (MTI) inhibit growth of pre-B and T-cell ALL cell lines in vitro and in ALL xenograft models. The MTI temsirolimus was chosen for use in this study due to its weekly intravenous dosing, its more predictable blood levels, and availability of a single-agent pediatric MTD and its sustained biologic effect due to conversion to sirolimus. This study will determine the maximum tolerated dose of temsirolimus that can given in combination with dexamethasone, cyclophosphamide and etoposide in relapsed ALL, LL or PTL. A standard 3-patient cohort dose-escalation design will be used. Response to treatment will be evaluated. Biology tests will be done to evaluate minimal residual disease (MRD), temsirolimus' effect on glucocorticoid resistance, and mTOR inhibition.

This study follows a standard 3+3 patient cohort escalation design, as described below:

1. Three patients are entered at the first dose level
2. If 0/3 experiences DLT at a given dose level, then the dose is escalated to the next higher level, if a higher dose level exists, and three patients are enrolled. If a higher dose level does not exists, up to three more patients are accrued at the same dose level.
3. If 1/3 experiences DLT at current dose, then up to three more patients are accrued at the same dose level.
4. If 2 or more DLTs are observed in a three-patient or six-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to three additional patients will be enrolled at the next lower dose level, if a lower dose level exists (unless six patients have already been treated at that prior dose).

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

A Phase I Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. All these analyses will be descriptive and exploratory and hypotheses generating in nature.

CR = Complete remission defined as attainment of bone marrow with \<5% blasts with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil counts (ANC) \> or = to 500/uL and platelet count \> or = to 50,000 microliters) CRi = Complete remission with incomplete blood count recovery defined as attainment of bone marrow with \>5% blasts with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC \< 500/uL or platelets \< 50,000 microliters PR = partial remission defined as complete disappearance of circulating blasts and achievement of 5-25% blasts if greater than 25% blasts originally without new sites of extramedullary disease and with recovery of ANC.

SD = stable disease defined as not satisfying criteria for PD, or has recovery of ANC \> or = to 500/uL and fails to qualify for CR, CRi, or PR PD = progressive disease defined as an increase of at least 25% in bone marrow leukemic cells

MRD positive is defined as \> or = to 0.1% MRD MRD negative is define as \< 0.1% MRD

All these analyses will be descriptive and exploratory and hypotheses generating in nature.

Pfizer

Therapeutic Advances in Childhood Leukemia Consortium

The definition of adverse event and/or serious adverse event used to collect adverse event information is the same as clinicaltrials.gov.

This is the starting dose of temsirolimus at 7.5 mg/m\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.

Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

Dose Level 1

If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.

Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

Dose Level 2

If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.

Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

Dose Level 3

If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4.

Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

Dose Level 4

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Australia

Region of Enrollment

# of prior therapies : 1 prior therapy

# of prior therapies : 2 prior therapies

# of prior therapies : 3 prior therapies

# of prior therapies : 4 prior therapies

# of prior therapies : 5 prior therapies

# of prior therapies : 6 prior therapies

# of prior therapies : 7 prior therapies

Prior transplant : Yes

Prior transplant : No

Prior CAR-T cell therapy : Yes

Prior CAR-T cell therapy : No

Total number of patients that were enrolled onto the study

Prior Therapy Regimens

Number of patients who were enrolled onto the study

All these analyses will be descriptive and exploratory and hypotheses generating in nature.

Roy Leong

Number of patients that initiated and completed study treatment.

Number of Patients That Experienced DLT During Cycle 1 of Therapy

Response Rate at the Completion of 1 Cycle of Study Treatment

MRD positive

MRD negative

Minimum Residual Disease (MRD) Levels Present at End of Cycle 1 Therapy in Patients

Overall Study

Antiemetics

Gastrointestinal Agents

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Daunorubicin

Dexamethasone acetate

BB 1101

Pegaspargase

Mercaptopurine

Thioguanine

Asparaginase

Ofatumumab

Antineoplastic Agents, Immunological

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

HIV Protease Inhibitors

Protease Inhibitors

Participants receive the study drugs in Induction, Consolidation, and Maintenance Courses.

Participants initially receive intrathecal treatment using Cytarabine 100 mg on Day 1. Induction chemotherapy must begin within 3 days of the intrathecal Cytarabine dose.

Consolidation Therapy 1: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and 8 - 11.

Consolidation Therapy 3B: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and Days 8 - 11.

Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.

Induction Therapy: Vincristine 1.5 mg/m2 by vein weekly for 4 doses.

Consolidation Therapy 1: Vincristine 1.5 mg/m2 by vein Week 3 and Week 4.

Consolidation Therapy 2: Vincristine 1.5 mg/m2 by vein every 10 days for 5 doses.

Consolidation Therapy 3A: Vincristine 1.5 mg/m2 by vein weekly for 3 doses.

Consolidation Therapy 3B: Vincristine 1.5 mg/m2 by vein Weeks 3 and 4.

Maintenance Therapy (24 months): Vincristine 1.5 mg/m2 by vein every 28 days.

Induction Therapy: Prednisone 60 mg/m2/day by mouth for 28 days.

Induction Therapy: PEG asparaginase 2000 IU/m2 by vein on Day 4 of induction.

Consolidation Therapy 1: PEG-asparaginase 2000 IU/m2 by vein Week 3 and Week 7.

Consolidation Therapy 2: PEG-asparaginase 2000 IU/m2 by vein Weeks 1 and 4.

Consolidation Therapy 3A: PEG-asparaginase 2000 IU/m2 by vein in Week 1.

Consolidation Therapy 3B: PEG-asparaginase 2000 IU/m2 by vein Week 3.

PEG asparaginase

Induction Therapy: Ofatumumab 300 mg by injection or vein on Day 2 and Ofatumumab 2000 mg by injection or vein on Day 15.

Consolidation Therapy 1: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.

Consolidation Therapy 2: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.

Consolidation Therapy 3A: Ofatumumab 2000 mg by injection or vein Week 1 and Week 3.

Induction Therapy: If Ofatumumab not available, Rituximab 375 mg/m2 by vein on Day 1 and on Day 15.

Consolidation Therapy 1: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.

Consolidation Therapy 2: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.

Consolidation Therapy 3A: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 3.

Induction Therapy: Intrathecal methotrexate 12 mg on Day 8 and Day 29.

Consolidation Therapy 1: Intrathecal methotrexate 12 mg Weekly, Weeks 1 - 4.

Consolidation Therapy 2: Methotrexate by vein every 10 days starting at 100 mg/m2 and increasing by 50 mg/m2 as tolerated. and Intrathecal methotrexate 12 mg Week 1.

Consolidation Therapy 3A: Intrathecal methotrexate 12 mg in Week 1.

Consolidation Therapy 3B: Intrathecal methotrexate 12 mg Week 1 and 2.

Maintenance Therapy (24 months): Methotrexate 20 mg/m2 by mouth weekly, hold on days of intrathecal methotrexate.

Maintenance Therapy (24 months): Intrathecal methotrexate 12 mg every 3 months for 4 doses.

Consolidation Therapy 1: Cyclophosphamide 1 gram/m2 by vein Week 1 and Week 5.

Consolidation Therapy 3B: Cyclophosphamide 1 gram/m2 by vein Week 1.

Consolidation Therapy 1: Mercaptopurine 60 mg/m2/day by mouth Days 1 - 14.

Maintenance Therapy (24 months): Mercaptopurine 75 mg/m2 by mouth nightly.

Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.

Consolidation Therapy 3A: Dexamethasone 10 mg/m2 by mouth on Days 1 - 7 and Days 15 - 21.

Maintenance Therapy (24 months): Dexamethasone 6 mg/m2/day by mouth Days 1 - 5 every 28 days.

Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.

Michael E. Rytting, MD

The goal of this clinical research study is to learn if a chemotherapy combination called augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab, can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety of these drug combinations will also be studied.

Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG asparaginase, and methotrexate.

Study Drug Administration:

If you are found to be eligible to take part in this study, on Day 1 or during the spinal tap procedure, you will be given cytarabine as an injection in your spinal fluid.

You will then receive the study drugs in Induction, Consolidation, and Maintenance Courses. Induction Therapy is designed to remove the signs of leukemia that can be seen and to allow normal blood cells to be restored. This is called remission. Consolidation and Maintenance Therapies are designed to cause the disease to stay in remission.

The study drugs will be given the following ways:

* Daunorubicin by vein over about 30 minutes
* Vincristine by vein over 15-30 minutes
* PEG asparaginase by vein over 15-60 minutes
* Methotrexate either by mouth or as an injection into your spinal fluid (intrathecal), depending on the course. When given through the spinal fluid, cerebrospinal fluid (CSF) will be collected with each spinal tap to test the fluid for leukemia. If there is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses each week until there is no disease present.
* Ofatumumab as an injection or by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug. If ofatumumab is not available, you will be given rituximab by vein over several (about 4-6) hours.
* Cyclophosphamide by vein over about 1 hour
* Cytarabine as an injection under the skin or by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug.
* Doxorubicin by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug.
* Prednisone, 6-Mercaptopurine, dexamethasone, and 6-Thioguanine are all taken by mouth

Within 3 days after you receive cytarabine, you will begin the Induction Course, which will last for 4 weeks. In the Induction Course, you will receive:

* Daunorubicin and vincristine on Days 1, 8, 15, and 22
* PEG asparaginase 1 time during Week 1
* Prednisone each day on Days 1-28.
* Intrathecal methotrexate at Weeks 2 and 5 during a spinal tap. If the is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses each week until there is no disease present.
* Ofatumumab or rituximab on Days 2 and 15

Depending on how you respond to Induction, you may begin the Consolidation Courses 1-4 weeks after Induction.

You will then receive Consolidation Course 1. This course will last 8 weeks, and you will receive:

* Cyclophosphamide at Weeks 1 and 5
* Cytarabine on or around Days 1-4 and Days 8-11 of each 4-week cycle
* 6-Mercaptopurine on Days 1-14 of each 4-week cycle
* Vincristine at Weeks 3 and 4 of each 4-week cycle
* PEG Asparaginase at Weeks 3 and 7
* Intrathecal methotrexate weekly during Month 1 only
* Ofatumumab or rituximab at Weeks 1 and 5

You will then receive 2 courses of Consolidation Course 2. Each course will last about 7 weeks, and you will receive:

* Vincristine and methotrexate every 10 (+/- 2) days for up to 5 doses
* PEG Asparaginase at Weeks 1 and 4
* Intrathecal methotrexate at Weeks 1 and 5
* Ofatumumab or rituximab at Weeks 1 and 5

You will then receive Consolidation 3 (Part A). This course will last for 4 weeks, and you will receive:

* Vincristine and doxorubicin at Weeks 1, 2, and 3
* Dexamethasone on Days 1-7 and Days 15-21
* PEG asparaginase at Week 1
* Intrathecal methotrexate at Week 1
* Ofatumumab or rituximab on Weeks 1 and 3

You will then receive Consolidation 3 (Part B). This course will last for 4 weeks, and you will receive:

* Cyclophosphamide at Week 1
* Cytarabine for 4 days in a row during Weeks 1-2
* 6-Thioguanine every day for the first 2 weeks.
* Intrathecal methotrexate at Weeks 1 and 2
* Vincristin at Weeks 3 and 4
* PEG Asparaginase at Week 3

Once you finish Consolidation, you will then receive 24 months of Maintenance Therapy.

* Vincristine every month.
* Dexamethasone for 5 days every month.
* 6-Mercaptopurine 1 time a day
* Methotrexate by mouth every week.
* If you have ALL, you will also receive intrathecal methotrexate every 3 months for the first 12 months of maintenance.

Study Tests/Procedures:

Induction:

* Blood (about 3 teaspoons) will be drawn about 2 times each week during the Induction Period for routine tests.
* You will have a bone marrow aspirate or biopsy on Days 15 and 29 and then as needed to check the status of the disease.
* About 7 days after you receive your first dose of PEG asparaginase, blood (about 1 tablespoon) will be drawn to check the activity of the drug in your blood. If the drug does not seem to be working well, your dose may be changed.
* If you have LL and bone marrow was not found to be involved with the disease at screening, you will have a chest x-ray, CT scans, and positron emission tomography (PET) scans to measure the disease. These scans will be done after about 28 days of therapy.

Consolidation 1:

* Blood (about 3 teaspoons) will be drawn for routine tests about 2 times each week.
* You will have a spinal tap during each intrathecal methotrexate dose. The spinal fluid will be checked for leukemia cells.
* You will have a bone marrow aspiration at the end of Month 2 to check the status of the disease.

Consolidation 2:

* Blood (about 3 teaspoons) will be drawn every 2 weeks for routine tests.
* You will have a spinal tap during each intrathecal methotrexate doses. The spinal fluid will be checked for leukemia cells.

Consolidation 3 (Part A and B):

* Blood (about 3 teaspoons) will be drawn at least weekly for routine tests.
* You will have a spinal tap during each intrathecal methotrexate dose. The spinal fluid will be checked for leukemia cells.

Maintenance:

* You will have a spinal tap during each intrathecal methotrexate dose. The spinal fluid will be checked for leukemia cells.
* You will have a bone marrow aspiration at least every 3-6 months to check the status of the disease.

Length of Study:

You may remain on study for as long as the study doctor thinks it is in your best interest. If the disease does not appear to be improving after Induction, you will be taken off study. You may be taken off study if the disease gets worse or comes back during treatment, if intolerable side effects occur, if your doctor thinks it is in your best interest, or if you cannot follow the study instructions.

Follow-up Visits:

Your study doctor will inform you of your follow-up visit schedule in the clinic. At each follow-up visit there will be a physical exam and blood (about 1 tablespoon) will be drawn for routine tests. You will be followed-up for the next 3 years after your the last dose of your chemotherapy.

This is an investigational study. The chemotherapy drugs used in this study are all FDA approved and commercially available for the treatment of various types of leukemia. The use of ofatumumab/rituximab in this drug combination, as well as the drug combination's use in pediatric patients, is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma	NCT01614197	Lymphoblastic L... Lymphoblastic L... Peripheral T-ce...	Temsirolimus Etoposide Cyclophosphamid... Methotrexate Hydrocortisone Cytarabine	1 Year - 21 Years	Therapeutic Advances in Childhood Leukemia Consortium
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT02419469	Leukemia Precursor-B Acu... Lymphoblastic L... Lymphoma	Cytarabine Daunorubicin Vincristine Prednisone PEG asparaginas... Ofatumumab Rituximab Methotrexate Cyclophosphamid... Mercaptopurine Doxorubicin Dexamethasone a... Thioguanine	12 Years - 30 Years	M.D. Anderson Cancer Center
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT02419469	Leukemia Precursor-B Acu... Lymphoblastic L... Lymphoma	Cytarabine Daunorubicin Vincristine Prednisone PEG asparaginas... Ofatumumab Rituximab Methotrexate Cyclophosphamid... Mercaptopurine Doxorubicin Dexamethasone a... Thioguanine	12 Years - 30 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ll

Every month we try and update this database with for ll 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 ll

Every month we try and update this database with for ll 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 ll 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.