Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

Follicular Lymphoma

Marginal Zone Lymphoma

Indolent B Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Ofatumumab

Intravenous; Dosage: 1000mg; Frequency: one time per week; Duration: 8 weeks

Steven Park, MD

This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular lymphoma or marginal zone lymphoma and participants will be age 70 or older.

The purpose of this research study is to learn about the safety of the treatment with the drug ofatumumab to find out what effects, both good and bad this treatment has on lymphoma. Ofatumumab is a monoclonal antibody. Monoclonal antibodies are being used to treat some types of cancer. Monoclonal antibodies are a type of protein made in a laboratory that can bind substances in the body including cancer cells. Ofatumumab binds to the protein called CD20, which is found on B-cells and lymphoma cells.

The study drug, Ofatumumab, is approved by the United States Food and Drug Administration (FDA) for treatment of other types of blood cancer and is not approved for use in patients with non-Hodgkin Lymphoma. The use of ofatumumab in this study is considered investigational.

In addition to learning about ofatumumab, the researchers are interested in learning about how this cancer treatment affects daily activities. Participants will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. This assessment will help the health care team understand a participant's "functional age" as compared to a participant's actual age.

The researchers also want to collect blood samples to study molecules in follicular lymphoma cells called 'biomarkers' to learn about how the lymphoma responds to therapy. A biomarker is a molecule (for example, DNA or protein) found in the blood or tissues that is a marker for disease. In this study, the investigators will measure the changes of the biomarker called bcl-2. This biomarker research will only be in subjects with follicular lymphoma.

This multicenter Phase II clinical study will investigate the overall response rate (ORR) after 2 months of therapy with weekly ofatumumab in older (≥70 years of age) patients with previously untreated low or intermediate risk indolent NHL (n=37). Secondary objectives include progression free survival (PFS) at 2 years, and an evaluation of the toxicity and tolerability of ofatumumab in this population.

We will also evaluate molecular response to ofatumumab by performing PCR analysis for BCL2/IgH from the peripheral blood.

We will conduct an exploratory analysis of the minimum observed serum concentration (Cmin) of ofatumumab prior to the last dose and correlate this level with ORR.

This trial includes administration of a Geriatric Assessment (GA) tool which patients will be asked to complete serially during the trial.

Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

A Phase II Trial Of Ofatumumab In Older (≥70 Years) Patients With Previously Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

The ORR will be evaluated as the rate of complete responses (CR) + partial responses (PR) as defined by the Revised Response Criteria for Malignant Lymphoma (RRCML)

PFS is defined as the time from study entry until lymphoma progression or death as a result of any cause.

Molecular response is defined as the percentage of patients with detectable BCL2 PCR at baseline who convert from BCL2 PCR-detectable to undetectable disease status in the peripheral blood.

GlaxoSmithKline

UNC Lineberger Comprehensive Cancer Center

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunomodulating Agents

Immunoglobulins

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

For patients with non-high risk FISH changes

Fludarabine Phosphate

Inhye Ahn, M.D.

Background:

- Ofatumumab was approved by the U.S. Food and Drug Administration to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not responded to standard chemotherapy. Ofatumumab is a substance that recognizes specific types of white blood cells called B-lymphocytes, which become cancerous in CLL/SLL. Ofatumumab attaches to a molecule called CD20, which is found on the surface of B-cells, and destroys them. Previous studies have shown that ofatumumab can decrease the number of B-cells in patients with CLL/SLL who have been treated with chemotherapy, but more research is needed to determine it if can also be used to treat patients with previously untreated CLL/SLL.

Objectives:

- To determine a safe and effective dose of ofatumumab, along with chemotherapy, to treat chronic lymphocytic leukemia or small lymphocytic lymphoma.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with CLL or SLL that has not been treated with chemotherapy.

Design:

* Eligible participants will be screened with a physical exam, blood samples, lymph node and bone marrow biopsies, and imaging studies.
* Participants will be separated into 2 groups: all participants will receive ofatumumab and fludarabine, and some participants will be selected to also receive cyclophosphamide (based on results of certain blood tests).
* Participants will receive the study drugs (ofatumumab and fludarabine, and optional cyclophosphamide) by infusion for a maximum of 6 days, followed by 21 days off drug.
* Participants will have 6 cycles of treatment according to a schedule set by the study doctors, and may have their dose levels adjusted if side effects develop.
* Participants who have disease remaining after 6 cycles will receive additional ofatumumab every 2 months, starting 2 months after the end of the 6th cycle and continuing for a total of 4 doses, before entering the follow-up phase of the trial. Participants who do not have residual disease after 6 cycles will not receive additional therapy, and will immediately enter the follow-up phase of the trial.
* Participants will have a follow-up exam every 2 to 4 months for 2 years after the end of treatment, and then as required by the study doctors for as long as the study remains open. These visits will involve a full medical exam, blood samples, lymph node and bone marrow biopsies, and imaging studies.

OUTLINE:

Patients with adverse interphase cytogenetics (11q22 or 17p13 deletion) receive FCO induction therapy:

* Ofatumumab is given IV on day 1 (300 mg) and day 8 (1000 mg) of course 1 and on day 1 (1000 mg) of all subsequent courses.
* Fludarabine phosphate (25mg/m2/d) and cyclophosphamide (250mg/m2/d) are given IV on days 2 through 4 of course 1 and on days 1 through 3 of all subsequent courses. Patients age 70 or older will be given reduced doses of fludarabine (20mg/m2/d) and cyclophosphamide (150mg/m2/d).
* Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.

Patients without adverse interphase cytogenetics receive FO induction therapy:

* Ofatumumab is given IV on day 1 (300mg) and day 8 (1000mg) of course 1 and on day 1 (1000mg) of all subsequent courses.
* Fludarabine phosphate (25mg/m2/d) is given IV on days 2 through 6 of course 1 and on days 1 through 5 of all subsequent courses.
* Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.

All patients are evaluated for minimal residual disease (MRD) by four-color flow cytometric analysis of the peripheral blood after completion of FO or FCO induction therapy, and are subsequently stratified into two groups:

* Patients who are MRD-positive and without evidence of disease progression proceed to consolidation therapy beginning approximately 5 months after completion of induction therapy, consisting of ofatumumab (1000mg) given IV on day 1 of all courses. Treatment repeats every 2 months for up to 4 courses in the absence of disease progression. Patients are followed clinically 2 and 6 months after the last dose of ofatumumab is given, and then every 6 months thereafter.
* Patients who are MRD-negative and without evidence of disease progression are followed clinically every 4 months for 1 year and every 6 months thereafter.

Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL

A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Death or disease progression defined by the 2008 IWCLL guideline as follows;

* Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging
* Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which was not previously present
* Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5000/ul
* Transformation to a more aggressive histology
* Occurrence of any cytopenia attributable to CLL. After treatment: the progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 20 g/L (2 g/dL) or to less than 100 g/L (10 g/dL), or by a decrease of platelet counts by more than 50% or to les

Number of Grade 3 and 4 treatment related adverse events as defined by CTCAE version 3.0 criteria.

CTCAE (Common Terminology Criteria for Adverse Events) provides a list of adverse event (AE) terms commonly reported. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 is a Mild AE; Grade 2 is a Moderate AE; Grade 3 is a Severe AE; Grade 4 is a Life-threatening or disabling AE; and Grade 5 is a Death related to AE

Participants with minimal residual disease (MRD) negativity following the completion of induction chemoimmunotherapy.

Participants with MRD negativity at the completion of consolidation immunotherapy who failed to achieve MRD negativity following completion of induction chemoimmunotherapy

Participants with complete response rates to induction chemoimmunotherapy.

Criteria for complete response (CR): CR requires all of the following:

* Peripheral blood lymphocytes \< 4000/uL
* Absence of significant lymphadenopathy by physical examination and appropriate radiographic techniques (CT or MRI). All lymph nodes must have regressed to \<=1.5cm in greatest diameter
* Absence of hepatomegaly or splenomegaly by physical examination, or appropriate radiographic techniques. Spleen, if enlarged before therapy must have regressed in size and must not be palpable by physical exam.
* Absence of constitutional symptoms
* Normal CBC, defined as: - Polymorphonuclear cells ≥ 1,500/uL - Platelets \> 100,000/uL (untransfused) - Hemoglobin \> 11 g/dL (untransfused)
* Bone marrow biopsy demonstrates normal cellularity for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent

Participants with complete response rates to induction chemoimmunotherapy.

Criteria for complete response (CR) requires all of the following: Peripheral blood lymphocytes \< 4000/uL. No significant lymphadenopathy. Lymph nodes regressed to \<=1.5cm. No hepatomegaly or splenomegaly. Spleen, if enlarged before therapy must have regressed in size and not be palpable. Absence of constitutional symptoms. Bone marrow biopsy demonstrates normal cellularity for age, with less than 30% of nucleated cells being lymphocytes. No lymphoid nodules.

Criteria for partial response (PR) requires at least one element of an abnormal CBC and at least one of the following: ≥ 50% decrease in peripheral blood lymphocyte count; ≥ 50% reduction in the sum of the products of lymph nodes up to 6 nodes or nodal masses. No new sites or increase in size of nodes; ≥ 50% reduction in pathologic enlargement of the liver and/or spleen by 50%.

Participants overall survival rate 2 years after initiation of induction chemoimmunotherapy

Median relationship of biomarker, CD20 expression with MRD negativity clinical response rate. Flow cytometry was use to quantified surface CD20 on peripheral blood.

University of Virginia

National Heart, Lung, and Blood Institute (NHLBI)

Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities

Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes

FCO (Fludarabine, Cyclophosphamide, and Ofatumumab)

Fludarabine and ofatumumab for patients with non-high-risk FISH changes

FO (Fludarabine and Ofatumumab)

FO Arm (Fludarabine and Ofatumumab)

FCO Arm (Fludarabine, Cyclophosphamide, and Ofatumumab)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring first-line therapy for CLL or SLL

Wiestner, Adrian MD, PhD

FO Arm

FCO Arm

The analyses included only those subjects who completed the induction period.

Progression Free Survival Rate 2 Years After Initiation of Induction Therapy

Neutropenia Grade 3

Thrombocytopenia Grade 3

Nausea Grade 3

Infusion reaction Grade 3

Neutropenia Grade 4

Lymphopenia Grade 4

Participants received Fludarabine and ofatumumab for patients with non-high-risk FISH changes or Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes.

FO + FCO Arms

All patients included in safety analysis. It was pre-specified to recombine Arms/Groups for this assessment and report irrespective of randomized group.

Number of Grade 3 and 4 Treatment Related Adverse Events

FO ARM

FCO ARM

Participants With Minimal Residual Disease (MRD) Negativity

Participants who achieved MRD negativity at the completion of consolidation immunotherapy

Participants With MRD Negativity at the Completion of Consolidation Immunotherapy Who Failed to Achieve MRD Negativity

FCO Arms

Participants With Complete Response Rates Following Induction Chemoimmunotherapy.

Participants received Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes.

Participants Overall Response Rates Following Induction Chemoimmunotherapy.

Participants Overall Survival Rate After Initiation of Induction Chemoimmunotherapy

Participants with Minimal Residual Disease (MRD) positivity following induction therapy received consolidation Ofatumumab for 4 cycles.

Minimal Residual Disease (MRD) Positivity

No additional therapy received for participants that had Minimal Residual Disease (MRD) negativity.

Minimal Residual Disease (MRD) Negativity

The analyses included only those subjects who completed the induction period. It was pre-specified to have arms/groups recombine for this assessment and report irrespective of randomized group.

Median Relationship of CD20 Expression With MRD Negativity Rate

Overall Study

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Dexamethasone

Cytarabine

Doxorubicin

Liposomal doxorubicin

Methotrexate

Prednisone

Rituximab

Vincristine

Daunorubicin

Dexamethasone acetate

BB 1101

Pegaspargase

Mercaptopurine

Thioguanine

Asparaginase

Antineoplastic Agents, Immunological

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

Tubulin Modulators

Antimitotic Agents

HIV Protease Inhibitors

Protease Inhibitors

Folinic Acid

Folate

Vitamin B9

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%.

Jazz Pharmaceuticals

M.D. Anderson Cancer Center

Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.

Ofatumumab Plus Chemotherapy

United States

Region of Enrollment

Rytting,Michael E.,M.D. / PEDIATRICS

Event Free Survival (EFS)

Etoposide

Ifosfamide

Lenograstim

Etoposide phosphate

Isophosphamide mustard

Mesna

Adjuvants, Immunologic

Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas	NCT01263418	Lymphoma, Non-H... Lymphoma, Folli... Lymphoma, B-Cel... Lymphoma, Low-G... Lymphoma, Inter...	Ofatumumab	70 Years -	UNC Lineberger Comprehensive Cancer Center
Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL	NCT01145209	Small Lymphocyt... CLL (Chronic Ly...	Fludarabine Pho... Ofatumumab Cyclophosphamid...	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
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
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas	NCT01329900	Lymphoma	Ofatumumab Ifosfamide Etoposide Mesna G-CSF Stem Cell Colle...	18 Years - 70 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
Phase IV Observational Study in Chronic Lymphocytic Leukemia	NCT01453062	Leukaemia, Lymp...	Arzerra	-	GlaxoSmithKline

Spots Global Cancer Trial Database for arzerra

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

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