Treatment Name: CLAG-M (Cladribine + Cytarabine + G-CSF + Mitoxantrone)
CLAG-M (Cladribine + Cytarabine + G-CSF + Mitoxantrone) is a Chemotherapy Regimen for Acute Myeloid Leukemia (AML)
How does CLAG-M work for acute myeloid leukemia?
Each of the medications in CLAG-M are designed to target and kill leukemia cells in the blood and bone marrow. GCSF is given to "trick" leukemia cells into beginning the process to divide while chemotherapy is being given. Because cladribine, ara-C, and mitoxantrone chemotherapy medications work best when cells are dividing, GCSF causes more AML leukemia cells to die from chemotherapy.
CL – Cladribine
A – Ara-C (Cytarabine)
G – GCSF (Filgrastim)
M - Mitoxantrone
Goals of CLAG-M therapy for AML:
CLAG-M is typically given to patients with relapsed or refractory AML after one or more prior treatments. The goal of CLAG-M is to eliminate leukemia cells from the body and to decrease symptoms from AML, such as bleeding, bruising, and recurrent infections. If CLAG-M leads to a remission from the leukemia, some patients go on to recieve a bone marrow transplant which is given to cure the leukemia.
Schedule for CLAG-M chemotherapy
- Cladribine intravenous (I.V.) infusion over 2 hours on Days 1, 2, 3, 4, and 5
- Cytarabine I.V. infusion over 4 hours (starting 2 hours after cladribine finishes) on Days 1, 2, 3, 4, and 5
- Mitoxantrone I.V. infusion over 30 minutes on Days 1, 2, and 3
- G-CSF (Filgrastim) subcutaneous injection once daily starting 24 hours the day before, or on the first day of chemotherapy, and continuing daily until Day 5. In some instances, G-CSF may be restarted seven days after chemotherapy and continued until the neutrophil count returns to normal range
Estimated total infusion time for CLAG-M:
- Up to 7 hours for Days 1, 2, 3, 4, and 5; however, since cladribine and cytarabine must be separated by four hours, it can take up to 9 hours to finish treatment each day
- 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
A bone marrow biopsy is usually performed after treatment when white blood cells and platelets return to the normal range to see if the leukemia is in remission. This may occur as early as Day 14, but some doctors prefer to wait until sometime between Day 21 to 28.
CLAG-M requires a 21 to 28 day stay in a hospital (sometimes longer) depending upon when white blood cell counts return to the normal range and also how well the side effects are tolerated or whether remission is achieved.
Only one cycle of CLAG-M is typically given; however, if remission is achieved, a second cycle of CLAG-M or a different chemotherapy regimen may be given to obtain a deeper (better) response.
Click here for the common CLAG-M 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 CLAG-M are shown here:
All patients during treatment experience very low red blood cells [anemia], white blood cells [neutropenia], and platelets [thrombocytopenia]. In clinical studies, patient received an average of 6 units of red blood cell transfusions and 24 units of platelet transfusions. Patients are also at risk of neutropenic fever.
Most side effects from CLAG-M can be managed with medications. In order to be prepared for handling side effects from CLAG-M, please watch all side effect videos shown below.
How often is monitoring needed with CLAG-M?
Labs (blood tests) may be checked every day during treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood phosphorus, uric acid, plus any others your doctor may order.
How often is imaging needed with CLAG-M?
Imaging may be checked if there are concerns for infection, bleeding, or other side effects. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.
How might blood test results/imaging affect treatment with CLAG-M?
Depending upon the bone marrow biopsy results, your doctor may advise to proceed onto consolidation chemotherapy or to a bone marrow transplant once your normal blood cells recover. If remission has not been achieved, your doctor may advise to change therapies.
- 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
- Corticosteroid eye drops, such as prednisolone eye drops, are often started before the first dose of cytarabine to prevent eye irritation known as conjunctivitis. Eye drops may be continued 48 to 72 hours after the last dose of cytarabine
- Short-term difficulty with writing, walking, or talking may occur but is rare and usually reversible. To prevent these problems, various neurological tests are done prior to each dose of cytarabine looking for early signs of toxicity. Examples of these tests include: following an object with your eyes, repeating various phrases, signing your name, or walking in a straight line
- CLAG-M requires a long stay in the hospital. Try to be as active as possible by taking walks in the hallway, or using an exercise bicycle in the room, if available. This will hopefully speed time to recovery
- An anti-fungal medication, such as posaconazole, may be prescribed to prevent a life-threatening invasive fungal infection
- Reactivation of herpes simplex virus (HSV) can occur. Prophylactic (preventative) anti-viral medications such as acyclovir (Zovirax®), valacyclovir (Valtrex®), or famciclovir (Famvir®) should be taken during treatment
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for AML. 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 CLAG-M (Cladribine + Cytarabine + G-CSF + Mitoxantrone), 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 CLAG-M (Cladribine + Cytarabine + G-CSF + Mitoxantrone). 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 CLAG-M (Cladribine + Cytarabine + G-CSF + Mitoxantrone) 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 CLAG-M (Cladribine + Cytarabine + G-CSF + Mitoxantrone)