A Phase 2 interventional study of Methotrexate and Vincristine in Leukemia, Lymphocytic, Acute, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-06-29.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 37 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Drug: Methotrexate · Drug: Vincristine · Drug: PEG-l-asparaginase · Drug: Dexamethasone · Drug: Rituximab
200 mg/m\^2 by vein on days 1 and 15.
Also known as: Rheumatrex
1.4 mg/m\^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.
Also known as: Oncovin®
2500 International units/m\^2 by vein on days 2 and 16
Also known as: Oncaspar®, PEG asparaginase, Pegaspargase, Polyethylene Glycol Conjugated Lasparaginase-H
40 mg by vein or by mouth daily days 1-4 and 15-18.
Also known as: Decadron®
Rituximab 375 mg/m\^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.
Also known as: Rituxan®
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.
Time frame: 6 cycles (cycle = 28 days)
Recruitment Period: March 6, 2009 to May 6, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
| Milestone | MOAD |
|---|---|
| Started | 37 |
| Completed | 36 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| percentage of participants | MOAD |
|---|---|
| Complete Response (CR) Rate | 28 |
Collected over Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MOAD | — | 33/37 (89.2%) | 37/37 (100%) |
| Event | MOAD |
|---|---|
| DeathGeneral disorders | 14/37 |
| PneumoniaInfections and infestations | 9/37 |
| Neutropenic FeverInfections and infestations | 7/37 |
| HypotensionCardiac disorders | 4/37 |
| MucositisGastrointestinal disorders | 4/37 |
| WeaknessGeneral disorders | 3/37 |
| DehydrationGastrointestinal disorders | 2/37 |
| Nausea and VomitingGastrointestinal disorders | 2/37 |
| Liver FailureHepatobiliary disorders | 2/37 |
| CellulitisInfections and infestations | 2/37 |
| Event | MOAD |
|---|---|
| Elevated Liver EnzymesHepatobiliary disorders | 34/37 |
| Elevated bilirubinHepatobiliary disorders | 31/37 |
| Decreased fibrinogenBlood and lymphatic system disorders | 26/37 |
| InfectionInfections and infestations | 26/37 |
| NauseaGastrointestinal disorders | 11/37 |
| NeuropathyNervous system disorders | 10/37 |
| Elevated amylase/lipaseMetabolism and nutrition disorders | 9/37 |
| MucositisGastrointestinal disorders | 8/37 |
| HyperglycemiaMetabolism and nutrition disorders | 8/37 |
| DiarrheaGastrointestinal disorders | 7/37 |
| Age, Continuous(years) | MOAD |
|---|---|
| Mean | 42 (22 to 69) |
| Sex: Female, Male(Participants) | MOAD |
|---|---|
| Female | 16 |
| Male | 21 |
| Region of Enrollment(participants) | MOAD |
|---|---|
| United States | 37 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center