Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01147 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Leadiant Biosciences, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOAD | Experimental | Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 200 mg/m^2 by vein on days 1 and 15. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate | 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. | 6 cycles (cycle = 28 days) |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gautam Borthakur, M.D. | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Recruitment Period: March 6, 2009 to May 6, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MOAD | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vincristine | Drug | 1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15. |
|
|
| PEG-l-asparaginase | Drug | 2500 International units/m^2 by vein on days 2 and 16 |
|
|
| Dexamethasone | Drug | 40 mg by vein or by mouth daily days 1-4 and 15-18. |
|
|
| Rituximab | Drug | Rituximab 375 mg/m^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain. |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MOAD | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response (CR) Rate | 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. | Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response. | Posted | Number | percentage of participants | 6 cycles (cycle = 28 days) |
|
|
|
Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOAD | 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. | 33 | 37 | 37 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary Arrest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea and Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatic Abcess | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver Dysfunction | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver Failure | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Candida Gabrata Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection due to Catheter | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenic Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pancreatitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Parotiditis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Septicemia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated Alanine transaminase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Right Hip Fracture/Fall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Altered Mental Status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Paralysis due to CNS disease | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leptomeningeal disease | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Liver Enzymes | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated bilirubin | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased fibrinogen | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated amylase/lipase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gautam Borthakur, MD/Associate Professor, Leukemia | University of Texas (UT) MD Anderson Cancer Center | 713-563-1586 | CR_Study_Registration@mdanderson.org |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D014750 | Vincristine |
| C042705 | pegaspargase |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided