Treatment Name: C10403 Maintenance
What is C10403?
C10403 is an aggressive and complex treatment regimen for adolescents and young adults (AYA) with ALL. The C10403 regimen is similar to treatment regimens given to pediatric patients (less than 18 y.o.) and are typically more aggressive than regimens given to adults (40 years or older).
The entire C10403 chemotherapy regimen consists of 5 different treatment courses: induction, consolidation, interim maintenance, delayed intensification, and maintenance (this page).
C10403 maintenance phase (Course V) typically begins shortly after completion of the delayed intensification phase, unless white blood cell count or platelets are too low.
The Maintenance Phase of C10403 (Course V) consists of the following four medications:
- Vincristine (Oncovin®)
- Dexamethasone (Decadron®)
- 6-Mercaptopurine (6-MP)
Alternative name: 10403, CALGB 10403 maintenance (Course V)
How does C10403 work?
Each of the medications in C10403 are designed to target and kill acute lymphoblastic leukemia cells in the blood, bone marrow, or wherever else they may be.
Goals of C10403 Maintenance therapy:
C10403 maintenance is given to eliminate any remaining leukemia cells and maintain remission from the leukemia. The C10403 protocol is commonly given with the goal of cure.
- Vincristine intravenous (I.V.) push or I.V. infusion over 10 to 15 minutes once per month (Days 1, 29, and 57)
- Methotrexate oral tablets by mouth once per week starting the second week of each cycle (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78)
- Do not take methotrexate on each Day 29 when I.T. methotrexate is given during the first four cycles of maintenance treatment
- Dexamethasone oral tablets by mouth twice daily for five consecutive days every 4 weeks (Days 1, 2, 3, 4, 5, then Days 29, 30, 31, 32, and 33, then Days 57, 58, 59, 60, and 61)
- 6-Mercaptopurine (6-MP) oral tablets by mouth once daily (at least one hour after evening meal) every day (Days 1 through 84 = 3 months).
- Different amounts of tablets may need to be taken on certain days of the week. Double check the prescribed daily dose each day before taking mercaptopurine
- Methotrexate intrathecal (I.T.) injection on Day 1 of every cycle of maintenance treatment and also on Day 29 of the first four cycles of maintenance treatment which is the first year of maintenance therapy
Estimated total infusion time for C10403 Maintenance (Course V) therapy:
- Up to 1 hour for Days 1, 29, and 57 of each cycle
- Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time
In C10403 maintenance therapy, vincristine is usually given in an outpatient infusion center, allowing the person to go home after each planned treatment. 6-Mercaptopurine, prednisone, and methotrexate are taken at home.
Each maintenance phase is repeated every 84 days (12 weeks). This is known as one Cycle. For women, each cycle is repeated to complete a total of 2 years of therapy from the start of interim maintenance therapy. For men, each cycle is repeated to complete a total of 3 years of therapy from the start of interim maintenance therapy.
NOTE: 6-Mercaptopurine (6-MP) must be filled at a retail pharmacy. Not all pharmacies carry this medicine so it is best to call ahead to ensure it is in stock before going there in person.
Click here for the common C10403 maintenance starting doses.
In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported serious (grade 3 or 4) side effects of C10403 maintenance are shown here:
- Neutropenic fever (17%)
- Infection (16%)
- Increased blood sugar (12%)
- Numbness or tingling in fingers or toes (9%)
- Mouth sores (3%)
- Fatigue (3%)
- Increased blood triglycerides (2%)
- Blood clot (1%)
- Inflammation of the pancreas (1%)
- Bleeding (1%)
On average, 1% of patients discontinue treatment due to unacceptable side effects.
How often is monitoring needed with C10403 Maintenance (Course V)?
Labs (blood tests) may be checked before treatment and periodically in-between treatments if needed. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood methotrexate levels, plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked before treatment and during treatment if there is a concern for infection or medication side effect. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.
How might blood test results/imaging affect treatment with C10403 Maintenance (Course V)?
Depending upon the results, your doctor may advise to continue C10403 as planned, or delay or switch therapy, or reduce the dose of specific medications due to side effects or low blood counts.
- Continuous exposure to 6-mercaptopurine (6-MP), rather than frequent stopping and restarting, has been shown to have better anti-leukemia effect. If 6-MP is causing side effects to the point where it is difficult to take, talk with your doctor to see if reducing the dose may be safe, yet still effective
- It is usually recommend to swallow mercaptopurine tablets whole. On occasion, your doctor may have you split them in half. However, the dose of mercaptopurine per week can often be achieved by alternating the number of tablets you take each day. Your doctor or pharmacist should tell you the exact number of tablets to take on each day of the week.
- Unless your doctor specifically tells you it is okay, you should NOT take allopurinol while taking 6-MP due to a drug interaction between these two medicines. If taken together, the allopurinol could lead to an unsafe build up of 6-MP in your body or cause the 6-MP to be less effective
- An antiviral medication such as acyclovir or valacyclovir (Valtrex®) is usually prescribed to prevent viral infections and is taken throughout therapy, including the maintenance phase (Course V)
- A medicine known as sulfamethoxazole/trimethoprim (more commonly called Bactrim®), is prescribed to prevent a specific type of pneumonia known as pneumocystis jiroveci pneumonia (PJP pneumonia). Because Bactrim can interact with certain medications such as methotrexate, even when methotrexate is given intrathecally, your doctor, nurse, or pharmacist will tell to hold certain doses to prevent potentially severe side effects from methotrexate
- Omeprazole (Prilosec&®) or a similar medication may be given to prevent ulcers from dexamethasone, however it is best not to take omeprazole on the days that methotrexate is given as it could make the methotrexate more toxic
- Patients may differ in the amount and activity of an enzyme they have that metabolizes 6-mercaptopurine, called TPMT. In some cases, genetic testing for TPMT may recommended before or during treatment with 6-mercaptopurine to test for low levels of this enzyme that could lead to increased side effects
- Clinical outcomes may be improved by seeking treatment from a University Hospital or National Cancer Institute (NCI)-sponsored cancer center where there may be more experts with experience in treating patients with acute lymphoblastic leukemia
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for ALL. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for C10403 Maintenance, we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for C10403 Maintenance. Depending upon your income, they may be able to help cover the cost of:
- Methotrexate Oral
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as C10403 Maintenance and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with C10403 Maintenance