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Treatment Name: C10403 Induction

C10403 Induction is a Chemotherapy Regimen for Acute Lymphoid Leukemia (ALL)

What is C10403 induction chemotherapy?
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 is usually considered more aggressive than regimens given to adults (40 years or older).

The entire C10403 chemotherapy regimen consists of 5 different treatment courses: induction (this page), consolidation, interim maintenance, delayed intensification, and maintenance.

Alternative name: 10403

The induction phase of C10403 consists of the following four medications:

  • Vincristine (Oncovin®)
  • Daunorubicin
  • Pegaspargase (Oncaspar®)
  • Prednisone (Deltasone®)

How does C10403 work?
Each of the medications in C10403 are designed to target and kills acute lymphoblastic leukemia cells in the blood, bone marrow, or wherever else they may happen to be.

Goals of therapy:
C10403 induction is given to eliminate the majority of leukemia cells from the blood and bone marrow. Following induction, the remaining treatment courses are given to eliminate any remaining leukemia cells and maintain remission from the leukemia. The C10403 protocol is commonly given with the goal of cure.

Schedule

  • Vincristine intravenous (I.V.) push or I.V. infusion over 10 to 15 minutes on Days 1, 8, 15, and 22
  • Daunorubicin I.V. push over 10 to 15 minutes on Days 1, 8, 15, and 22
  • Pegaspargase I.V. infusion or over 1 to 2 hours or intramuscular (I.M.) injection on Day 4 only
  • Prednisone oral tablets by mouth once daily on Days 1 through 28. Typically, 2 to 5 tablets need to be taken at the same time to equal the total daily dose
  • Cytarabine intrathecal (I.T.) injection on Day 1
  • Methotrexate I.T. injection on Days 8 and 29

Click here for the common C10403 induction starting doses

A bone marrow biopsy is typically performed on Day 29, after completion of induction treatment. If leukemia cells are still detected on the biopsy, 2 weeks of an extended remission induction treatment may be given:

  • Vincristine intravenous (I.V.) push or I.V. infusion over 10 to 15 minutes on Days 1 and 8
  • Daunorubicin I.V. push over 10 to 15 minutes on Days 1 and 8
  • Pegaspargase I.V. infusion or over 1 to 2 hours or intramuscular (I.M.) injection on Day 4 only
  • Prednisone oral tablets by mouth once daily on Days 1 through 14. Typically, 2 to 5 tablets need to be taken at the same time to equal the total daily dose

Click here for the common C10403 extended remission induction starting doses.

Estimated total infusion time for this treatment:

  • Up to one hour for Days 1, 8, 15, and 22 and up to 3 hours for Day 4
  • 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
  • Intrathecal chemotherapy administration may also add 1 - 3 hours to the time spent in the clinic or hospital on the days that it is given

C10403 induction is usually given in a hospital and requires a 29-day stay in the hospital (or sometimes longer) depending upon when white blood cell counts return to the normal range, how well the side effects are tolerated, and if extended remission induction treatment is needed. After the induction phase of C10403, the remaining phases of treatment may be administered in the outpatient setting, without the need of further hospitalization unless specific side effect management is needed.

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment until stable. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), LDH, phosphorus, uric acid, prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen, amylase, lipase, triglycerides, plus any others your doctor may order.

Minimal residual disease, or MRD, uses your blood or bone marrow cells to see if any leukemia cells can still be detected in the body. MRD may be tested using either flow cytometry, quantitative polymerase chain reaction (qPCR), or both.

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. An echocardiogram or multigated acquisition (MUGA) scan may be performed before treatment to check your left ventricular ejection fraction (LVEF).

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue C10403 as planned, decrease doses of certain medications, or delay treatment until recovery. If MRD testing shows remaining leukemia cells, additional treatment may be given during the induction phase. 

ChemoExperts Tips

  • During the first few days of therapy, you will be monitored closely for tumor lysis syndrome (TLS). Signs of TLS are high levels of potassium, phosphorous and uric acid and low levels of calcium in the blood. Allopurinol is a medication commonly given at the start of therapy to prevent the development of high uric acid levels in the blood. Additional medications may need to be given if TLS develops
  • 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 to hold certain doses to prevent potentially severe side effects from methotrexate
  • An anti-fungus medicine will be given to you during the induction phase of C10403. Some centers prefer to administer an I.V. anti-fungal medicine to avoid a drug interaction with vincristine. When no vincristine is given, such as during the consolidation phase, the anti-fungal medication can safely be administered as an oral medicine in pill form
  • 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®). If severe allergic reactions develop, an alternate form of pegaspargase (known as Erwinia, or Erwinaze®) may be given instead
  • If pegasparaginase is given by intramuscular (I.M.) injection, multiple injections may have to be given as only a certain volume of pegasparaginase can be injected at once
  • Omeprazole (Prilosec®) or a similar medication may be given to prevent ulcers from prednisone, 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 Induction, 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 Induction. Depending upon your income, they may be able to help cover the cost of:

  • Vincristine
  • Daunorubicin
  • Pegaspar­gase
  • Pred­nisone

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 Induction 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.

Emotional Wellness

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 Induction

Individual Drug Label Information

Vincristine (Oncovin®)

  • ​Vincristine MUST only be given by intravenous infusion. May NOT be administered any other way
  • Dosage may be reduced in patients with poor liver function
  • May interact with certain antifungal medications
  • Vincristine will cause death if administered into spinal fluid
General Vincristine (Oncovin) Side Effects
  • Nerve pain in hands or feet may increase after each dose. It is usually reversible if treatment is stopped or dose is adjusted
  • Hair loss is NOT common if vincristine is given by itself
  • May cause constipation; preventative medicines may help decrease or avoid constipation
  • Leakage into skin or surrounding muscle may cause severe irritation (extravasation)
  • Click on the vincristine (Oncovin) package insert below for reported side effects and potential drug interactions

Side Effect Videos
ConstipationConstipationPainPain

See DailyMed package insert.

Daunorubicin

  • ​Daunorubicin is administered as an intravenous infusion and is red in color
  • Is may be given as a slow intravenous push over 5 – 10 minutes, or as a longer infusion over several hours
  • Can affect heart function. A heart study (echocardiogram) may be required before receiving the first dose
  • Dosage may be reduced in patients with poor liver function
  • Has been linked to the development of other cancers in a small number of people (1.5% chance at 10 years)
General Daunorubicin Side Effects
  • Increases your risk of bleeding.  It is normal to receive red blood cell & platelet transfusions if receiving daunorubicin
  • May cause nausea, vomiting, diarrhea, and mouth sores (stomatitis)
  • Leakage into skin or surrounding muscle may cause severe irritation (extravasation)
  • May temporarily turn urine orange
  • Causes hair loss, This is usually temporary and reversible
  • May increase the risk of infection due to decrease white blood cell count (neutropenia). It is normal to receive I.V. antibiotics after daunorubicin is infused
  • Click on the daunorubicin package insert below for reported side effects and potential drug Interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Pegaspar­gase (Oncaspar®)

  • Is an intravenous infusion or intramuscular injection
  • Dosage adjustments may be required for liver function or side effects
General side effects from pegaspargase (Oncaspar®)
  • May cause infusion reactions. Premedications may be given prior to pegasparaginase to help prevent infusion reactions
  • Can cause problems with the body’s clotting system causing it to clot too much or not enough and cause bleeding. Contact your doctor if you notice any unusual bruising or bleeding, unexplained pain in your legs or arms, chest pain, or severe shortness of breath
  • Severe liver injury can occur. Some signs of serious liver injury can be yellowing of skin or eyes, abdominal pain or dark colored urine
  • May cause inflammation of the pancreas (pancreatitis). Contact your doctor if you experience any unexplained severe abdominal pain
  • May cause an increase in blood sugar. If you have diabetes, you may need to adjust the doses of your insulin or hypoglycemic medications
  • Click on the pegasparaginase (Oncaspar®) package insert below for reported side effects and possible drug interactions

Side Effect Videos
BleedingBleedingPainPainBlood ClotsBlood Clots

See DailyMed package insert.

Pred­nisone

  • Prednisone is an oral medication, usually supplied as a white tablet
  • Prednisone may increase the risk of infection. Depending upon how much prednisone is taken, antibiotics may be prescribed to help prevent infections during treatment with prednisone
  • Should be taken with food and with a large glass of water to avoid stomach irritation or ulcers
  • Should be taken before 6 P.M. when possible, to avoid trouble falling asleep
  • May decrease the response to vaccines; vaccines may need to be repeated at a later date to obtain maximal response
  • If taken daily for several days or weeks, the dose of prednisone may need to be gradually decreased to avoid withdrawal symptoms
  • If you miss a dose, take the next dose as soon as possible
  • Should be stored at room temperature
General Prednisone Side Effects
  • May cause high blood sugar, weight gain, irritability, high blood pressure, difficulty sleeping, stomach ulcers, bone loss, muscle weakness
  • Click on the Prednisone package insert below for reported side effects and potential drug Interactions
See DailyMed package insert.

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References

Curran E, Stock W. How I treat acute lymphoblastic leukemia in older adolescents and young adults. Blood 2015;125:3702-3710.

Created: January 31, 2017 Updated: October 8, 2018

What is Acute Lymphoid Leukemia (ALL)?

Acute Lymphoid Leukemia (ALL), also known as acute lymphoblastic leukemia, is a disease of the lymphoid cells found in the bone marrow. Lymphoid cells are responsible for developing into cells of the immune system called B-cells, T-cells, or Natural Killer cells. In ALL, immature lymphoid cells know as "blasts" replicate at a very fast rate. Sometimes blasts crowd out the normal cells in the bone marrow so that red blood cells or platelets are unable to develop.

Common symptoms of ALL include fatigue, infection, and bruising or bleeding. ALL is the most common cancer diagnosed in children, but is rare in adults. Most cases of ALL are considered "de novo" meaning that the cause is unknown; however, some cases can be linked to certain genetic syndromes. There is no staging system for ALL. Chromosomes are often analyzed to determine which mutations in the chromosomes exist. The effectiveness of the treatment may depend upon the specific chromosome mutations that are present.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose your therapy.

What are adolescents and young adults (AYAs)?

The age range for this population is generally considered to be those between 18 - 39 years old, although this age range may vary slightly.

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common C10403 induction starting doses

  • Vincristine 1.5 mg/m2 (maximum 2 mg) intravenous (I.V.) push or I.V. infusion over 10 to 15 minutes on Days 1, 8, 15, and 22
  • Daunorubicin 25 mg/m2 I.V. push over 10 to 15 minutes on Days 1, 8, 15, and 22
  • Pegaspargase 2,500 IU/m2 (maximum 3,750 Units) I.V. infusion or over 1 to 2 hours or intramuscular (I.M.) injection on Day 4 only
  • Prednisone 60 mg/m2/day oral tablets by mouth once daily on Days 1 through 28. Typically, 2 to 5 tablets need to be taken at the same time to equal the total daily dose
  • Cytarabine 70 mg intrathecal (I.T.) injection on Day 1
  • Methotrexate 15 mg I.T. injection on Days 8 and 29

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Common C10403 extended remission induction starting doses

  • Vincristine 1.5 mg/m2 (maximum 2 mg) intravenous (I.V.) push or I.V. infusion over 10 to 15 minutes on Days 1 and 8
  • Daunorubicin 25 mg/m2 I.V. push over 10 to 15 minutes on Days 1 and 8
  • Pegaspargase 2,500 IU/m2 (maximum 3,750 Units) I.V. infusion or over 1 to 2 hours or intramuscular (I.M.) injection on Day 4 only
  • Prednisone 60 mg/m2/day oral tablets by mouth once daily on Days 1 through 14. Typically, 2 to 5 tablets need to be taken at the same time to equal the total daily dose

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is fibrinogen?

Fibrinogen is a clotting factor that gets converted to fibrin and plays a role in the final steps of clot formation. Fibrinogen may be supplemented during treatment in the form of cryoprecipitate, a human-derived product, that is transfused by I.V. infusion to increase fibrinogen levels and decrease the risk of bleeding.

What is amylase?

Amylase is an enzyme that is produced by the pancreas that helps the body break down and digest carbohydrates. When the pancreas is injured, amylase is leaked out into the blood. Amylase, along with lipase, can be monitored to check for possible injury to the pancreas, indicated by elevated levels of the enzymes in the blood.

What is lipase?

Lipase is an enzyme that is produced by the pancreas that helps the body break down fats. When the pancreas is injured, lipase is leaked out into the blood. Lipase, along with amylase, can be monitored to check for possible injury to the pancreas, indicated by elevated levels of the enzymes in the blood.

What is left ventricular ejection fraction (LVEF)?

LVEF refers to the amount of blood pumped by the left ventrical (chamber) of the heart into the body with each heartbeat. Certain drugs can decrease heart function and result in less blood being pumped by each heartbeat than normal.

What is "Tumor Lysis Syndrome"?

Tumor lysis syndrome occurs when many cancer cells die quickly and release their contents into the bloodstream. Many times the body has the ability to flush these substances out through the kidneys or metabolize them via the liver. However, sometimes the body needs medicines to help eliminate these substances and to prevent organ damage.

What is an "Intrathecal injection" or "IT injection"?

Intrathecal (I.T.) injection is a procedure where a needle is inserted into the spinal canal of the lower back to access the space that contains the cerebral spinal fluid (CSF). Typically, once the needle is inserted, a small amount of CSF is taken out and chemotherapy is then injected into the CSF. This is most often performed to treat cancer that is present in the CSF or to prevent cancer from invading the CSF. It is important that patients lie flat for 30 min - 1 hour after receiving an I.T. injection.