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Antineoplastic Agents

All Drugs and Chemicals

Pegaspargase

Asparaginase

Oncaspar

500, 1000 or 1500 U/m2 BSA single infusion

PEG-rASNase

Nicola Gökbuget, MD

This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.

Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

A Randomized, Multi-centre, Parallel-group, Open Label, Oncaspar® Controlled Dose Ranging Trial of Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.

-the rate of patients with asparagine depletion

the rate of patients with L-asparaginase (ASNase) activity levels in serum \> 100 U/L

the duration of ASNase activity levels in serum \> 100 U/L and its variability pharmacokinetic parameters Cmax, t½, CLtotal, Kel, AUC0-t and AUC0-∞

the time profiles of ASNase activity and amino acid levels Asparagine (ASN), Aspartic acid (ASP), Glutamine (GLN) and Glutamic acid (GLU) in serum

the incidence of increased bilirubin grade III/IV

the incidence of all other adverse events

medac GmbH

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Dexamethasone

Methotrexate

Rituximab

Vincristine

Dexamethasone acetate

BB 1101

Antineoplastic Agents, Immunological

Immunologic Factors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).

1.4 mg/m\^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.

2500 International units/m\^2 by vein on days 2 and 16

PEG-l-asparaginase

40 mg by vein or by mouth daily days 1-4 and 15-18.

Rituximab 375 mg/m\^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.

Gautam Borthakur, M.D.

This goal of this clinical research study is to learn if the combination of methotrexate, pegylated-L-asparaginase, vincristine, and dexamethasone (also rituximab in some patients) can help to control ALL that has not responded to previous treatment or has come back after a response or chronic myeloid leukemia (CML).

The Study Drugs:

Methotrexate is designed to disrupt cells from making and repairing DNA (the genetic material of cells) and "copying" themselves.

Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Pegylated-L-asparaginase is designed to get rid of an important building block of proteins in leukemia cells.

Dexamethasone is a steroid that causes the leukemia cells to breakdown.

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive methotrexate through a needle in your vein on Days 1 and 15 (+/- 2 days) over 2 hours. You will receive vincristine by vein on Days 1, 8 and 15 (+/- 2 days) over 30 minutes. You will receive pegylated-L-asparaginase by vein on Days 2 and 16 (+/- 2 days) over about 2 hours. You will receive dexamethasone by vein over about 30 minutes or by mouth on Days 1-4 and 15-18 (+/- 2 days). If leukemia cells have a protein called cluster of differentiation antigen 20 (CD20), you will also receive rituximab by vein on Days 1 and 15 of Cycles 1-4 (+/- 2 days) over about 2-8 hours.

Each cycle will be at least 28 days.

If you have Philadelphia positive ALL, you may continue to receive a tyrosine kinase inhibitor (TKI). Examples of TKIs include Imatinib, Dasatinib, and Nilotinib. If you are not taking a TKI, you may begin taking a TKI. Your doctor will describe treatment with TKIs with you in more detail.

Once your blood counts improve and your leukemia is under control your doctor may decide to continue on treatment every 4-6 weeks. If your leukemia is not under control after the first cycle, your doctor may decide to start the next cycle without your blood counts improving.

Study Visits:

During Cycle 1, blood (about 2 teaspoons) will be drawn at least 1 time each week for routine tests. If the doctor thinks it is necessary, you may be asked to have additional blood drawn.

Between Days 14-28 of Cycle 1, you will have a bone marrow aspirate to check the status of the disease. This test may be delayed or repeated if your doctor does not think you are in remission.

Since pegylated-L-asparaginase can cause problems with blood clotting and inflammation of the pancreas, on Days 2 and 16 of All cycles, blood (about 2 teaspoons) will be drawn to check how well your blood clots and to check the health of your pancreas.

During Cycles 2- 6, blood (about 2 teaspoons) will be drawn for routine tests at least 2 times each month.

If the doctor thinks it is necessary, you may have a bone marrow aspirate to check the status of the disease.

Length of Study:

You may receive the study drugs for up to 6 cycles. You will be taken off study early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to receive the study drug(s).

This is an investigational study. Methotrexate, pegylated-L-asparaginase, and vincristine are all FDA approved for use in ALL. Dexamethasone is FDA approved as a steroid and steroids are traditionally an important part of treatment of leukemia. Rituximab is FDA approved for the treatment of non-Hodgkin's lymphoma. The combination of all these drugs is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage

Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage

Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above and platelet count of 100 x 10\^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.

Leadiant Biosciences, Inc.

M.D. Anderson Cancer Center

The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.

MOAD

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Gautam Borthakur, MD/Associate Professor, Leukemia

Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response.

Complete Response (CR) Rate

Overall Study

Lymphoma, Non-Hodgkin

Anti-Infective Agents

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Daunorubicin

Mercaptopurine

Thioguanine

Ofatumumab

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antiviral 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
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia	NCT01251809	Acute Lymphobla...	Oncaspar PEG-rASNase	18 Years - 55 Years	medac GmbH
Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage	NCT00905034	Leukemia, Lymph...	Methotrexate Vincristine PEG-l-asparagin... Dexamethasone Rituximab	1 Year -	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
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 oncaspar

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

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