Treatment Name: C10403 Interim 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 (this page), delayed intensification, and maintenance.
C10403 interim maintenance (Course III) typically begins shortly after completion of the consolidation phase, unless white blood cell count or platelets are too low.
The interim maintenance phase (Course III) of C10403 consists of the following three medications:
- Vincristine (Oncovin®)
- Pegaspargase (Oncaspar®)
How does C10403 therapy 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 happen to be.
Goals of C10403 interim maintenance (Course III) therapy:
C10403 interim maintenance (Course III) 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.
- Methotrexate intravenous (I.V.) push on Days 1, 11, 21, 31, and 41
- Vincristine I.V. push or I.V. infusion over 10 to 15 minutes on Days 1, 11, 21, 31, and 41
- Pegaspargase I.V. infusion over 1 to 2 hours or intramuscular (I.M.) injection on Days 2 and 22
- Pre-medications, including diphenhydramine (Benadryl®), hydrocortisone, and acetaminophen (Tylenol®) may help to reduxce the risk of significant hypersensitivity or allergic reaction from pegaspargase (Oncaspar®)
- If anaphylaxis occurs from PEGaspargase, your doctor may switch you to another type of asparaginase known as Erwinia asparaginase
- Methotrexate intrathecal (I.T.) injection on Days 1 and 31
If your white blood cells or platelets are too low on treatment day, your dose of methotrexate and vincristine may need to be delayed and you will have your blood counts rechecked, likely in 4 days. If your blood counts recover to acceptable levels, your dose of methotrexate and vincristine may then be given. If your blood counts do not recover to acceptable levels, vincristine only may be given and the dose of methotrexate may need to be skipped or delayed. Your white blood cell and platelet counts do not affect the decision to administer pegaspargase therapy.
Estimated total infusion time for C10403 Interim Maintenance:
- Up to 2 hours for days when methotrexate and vincristine are both given. Up to 2 hours on days when pegaspargase is given
- Infusion times are based on clinical studies, but may vary depending on doctor preference, patient tolerability, and drug availability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time
- Intrathecal chemotherapy administration may also add 1 to 3 hours to the time spent in the clinic or hospital on the days that it is given
C10403 interim maintenance is usually given in an outpatient infusion center, allowing the person to go home after each planned treatment. On occasion, C10403 interim maintenance may be given in the hospital if close monitoring is needed.
Click here for the common C10403 Interim 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 interim maintenance (Course III) are shown here:
- Neutropenic fever (44%)
- Infection (26%)
- Numbness or tingling in fingers or toes (15%)
- Increased blood triglycerides (12%, may require treatment)
- Fatigue (12%)
- Increased blood sugar (11%)
- Allergic reaction (11%)
- Blood clot (9%)
- Mouth sores (9%)
- Inflammation of the pancreas, or pancreatitis (4%)
- Difficulty with using hands or feet, such as buttoning a short or walking up stairs (4%)
On average, 2% of patients discontinue interim maintenance (Course III) due to unacceptable side effects.
How often is monitoring needed?
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), prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen, amylase, lipase, triglycerides, 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?
Depending upon the results, your doctor may advise to continue C10403 interim maintenance (Course III) as planned, or delay or switch therapy, or adjust doses of certain medications for tolerability.
- Leucovorin is a form of folic acid used to rescue either cells, or prevent damage from methotrexate when larger dose of methotrexate are given. Leucovorin is typically given until blood levels of methotrexate decrease to an acceptable level
- An antiviral medication such as acyclovir or valacyclovir (Valtrex®) is usually prescribed to prevent viral infections and taken throughout therapy, including the maintenance phase
- 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, your doctor, nurse, or pharmacist will tell you to hold certain doses to prevent potentially severe side effects from methotrexate
- Premedications such as acetaminophen (Tylenol®) and diphenhydramine (Benadryl®) are typically given prior to pegaspargase (Oncaspar®) to help prevent infusion reactions. With pre-medications, severe reactions develop in roughly 6% of patients receiving pegaspargase (Oncaspar®), without pre-medications reactions may be as high as 15%. If severe allergic reactions develop, an alternate form of pegaspargase (known as Erwinia, or Erwinaze®) may be given instead
- If pegaspargase is given by intramuscular (I.M.) injection, multiple injections may have to be given as only a certain volume of pegaspargase can be injected at once
- Omeprazole (Prilosec®) or a similar medication may be given to prevent stomach ulcers, however it is best not to take omeprazole on the days that methotrexate is given as it could make the methotrexate more toxic
- 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 Interim 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 Interim Maintenance. Depending upon your income, they may be able to help cover the cost of:
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 Interim 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 Interim Maintenance