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CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV Day 2 over 4- 6 hours.

25 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.

250 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.

30 mg IV on Days 1, 3 and 5 over 2-4 hours; repeated every four weeks for a total of 6 planned cycles.

Cycle 1 (Week 1): 375 mg/m\^2/day IV on Day 2 over 4- 6 hours

Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV on Day 2 over 4- 6 hours

William G. Wierda, MD, PhD, BS

The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy.

Primary Objectives:

Evaluate the therapeutic efficacy, including the complete remission (CR), nodular partial remission (NPR), and partial remission (PR) rates (overall response) of combined cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) in previously treated patients with Chronic Lymphocytic Leukemia (CLL).

Second Objectives:

* Assess the toxicity profile of CFAR in previously treated patients with CLL.
* Monitor for infection and determine incidence and etiology of infection including cytomegalovirus in patients treated with CFAR.
* Evaluate molecular remission by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responding patients treated with CFAR.
* Assess immune parameters, including pretreatment, during treatment, and post-treatment blood T-cell counts and subset distribution and serum immunoglobulin levels in patients treated with CFAR.

Fludarabine is a chemotherapy drug that is approved for the treatment of CLL. Cyclophosphamide is also a chemotherapy drug that is commonly used in the treatment of CLL. Rituximab and alemtuzumab are special proteins that specifically target and attach to proteins on leukemia cells. These targeted proteins may also be present on normal blood cells. When these drugs bind to the proteins on leukemia cells, they may help to stop or slow the growth of the disease. The combination of fludarabine, cyclophosphamide and rituximab has been used in the treatment of CLL. The purpose of this study is to determine if there is added benefit with the addition of alemtuzumab to this combination.

Before treatment starts, you will have a complete physical exam, including blood tests (about 3 tablespoons). You may have either a chest x-ray or a computed tomography (CT) scan if your doctor feel this is necessary. If you have not had a bone marrow sample collected in the past 4 months, you will have a bone marrow sample collected at this time. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test.

During the study, you will have up to 6 "cycles" of treatment. A cycle is made up of treatment with the study drugs for 5 days in a row, then around 31/2 weeks (23 days) of no treatment with the study drugs. On Days 1, 3, and 5 of each cycle you will receive alemtuzumab through a needle in a vein. On Day 2 of each cycle you will receive rituximab through a needle in a vein. Cyclophosphamide and fludarabine will be given separately on Days 3, 4, and 5 of each cycle through a needle in a vein. In addition to the study drugs, you may also be given fluids by vein. The combination treatment will be repeated every 4 weeks (one cycle) for a total of up to 6 cycles. This treatment will be given on an outpatient basis. The injections for each daily treatment visit should take less than 6 hours.

You will receive acetaminophen (Tylenol) by mouth and diphenhydramine hydrochloride (Benadryl) by mouth or vein 30 - 60 minutes before each dose of rituximab and alemtuzumab. You will also receive hydrocortisone (a steroid) by vein before each dose of alemtuzumab. These drugs will be used to help decrease side effects. If side effects occur during a treatment, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you experience side effects during treatment, you must stay in the clinic for 2 hours after the drug is given to be observed.

If you begin to experience side effects due to treatment, the dose(s) of the drug(s) may be lowered or the treatment may be temporarily stopped until the symptoms are gone.

During the treatment and for two months after completion of treatment you will need to take prophylactic antibiotics to prevent you from developing infection. Trimethoprim/sulfamethoxazole (Bactrim DS) is a sulfa-drug and you will be given this to prevent a type of pneumonia called PCP pneumonia. If you are allergic to sulfa drugs, an equivalent antibiotic will be given. You will take Valtrex to prevent virus reactivation including herpes. If you are allergic to Valtrex, an equivalent antibiotic will be given. You may receive an additional antibiotic to suppress another virus, cytomegalovirus called Valcyte. You may also take allopurinol for the first week of the first course of treatment. This will help prevent kidney damage from rapid destruction of your leukemia cells.

During the first cycle of treatment, you will have blood drawn (about 2 tablespoons) for blood tests once a week. Then, these blood tests will be repeated before the start of each additional cycle (every 4 weeks).

After 3 cycles of treatment, you will have a physical exam and blood tests (about 2 tablespoons). You may also have either an x-ray or a CT scan. You will have another bone marrow sample collected. These tests will be used to see if the disease is responding to treatment. If it is found that the disease is not responding to treatment after the first 3 cycles of therapy, you will be taken off the study and your doctor will discuss other treatment options with you. If it is found that the disease is responding to treatment, another 3 cycles (12 weeks) of treatment will be given (6 cycles total). During these additional 3 cycles of therapy, you will have blood drawn (about 2 tablespoons) once a week for routine blood tests.

After 6 cycles of treatment, you will have a physical exam and have around 2 tablespoons of blood drawn for routine blood tests.

Around 3-6 months after you receive your last treatment cycle, you will have a physical exam and blood tests (about 2 tablespoons). After that, you will have a physical examination and blood tests (about 2 tablespoons) every 6 months for the next 2 years. If your disease returns or if you start on more treatment, you will not need to return for these visits. However, you should inform the study doctor/staff that you are receiving other treatment.

If at any time during the study the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

This is an investigational study. All of the drugs used in the study are FDA approved and commercially available. As many as 80 patients will take part in the study. All will be enrolled at M. D. Anderson.

Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)

Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as \> 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is \> 50% decrease of clinical symptoms from baseline and recovery from blood counts.

Bayer

M.D. Anderson Cancer Center

CFAR

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

William G. Wierda, MD, PhD, BS / Associate Professor

Complete remission (CR)

Nodular partial remission (NPR)

Partial remission (PR)

Number of Participants With an Overall Response

Overall Study

CFAR = Cyclophosphamide 200 mg/m\^2/day 3-5 intravenous (IV) 5-30 minutes, Fludarabine 20 mg/m\^2/day 3-5 IV 5-30 minutes, Alemtuzumab 30 mg 1, 3,5 IV 2-4 hours, and Rituximab 375 mg/m\^2/day 2 IV 4-6 hours

William G. Wierda, M.D., Ph.D.

Primary Objective:

1. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with \<5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a historic group of patients treated with the combination fludarabine, cyclophosphamide, and rituximab (FCR).

Second Objectives:

1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR.
2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responders treated with CFAR.
3. Assess immune parameters including blood T cell counts and subset distribution and serum immunoglobulin levels pretreatment, during treatment, and post-treatment in patients treated with CFAR.

Fludarabine is a chemotherapy drug that is approved for the treatment of patients with Chronic Lymphocytic Leukemia (CLL). Cyclophosphamide is also a chemotherapy drug that is commonly used to treat patients with CLL. Rituximab and alemtuzumab are special proteins (antibodies) that specifically target and attach to proteins on leukemia cells. These targeted proteins may also be present on normal blood cells. When these antibodies bind to the proteins on leukemia cells, they may help to stop or slow the growth of the disease. The combination of fludarabine, cyclophosphamide, and rituximab has been used in the treatment of previously untreated patients with CLL. The purpose of this study is to see if there is added benefit with the addition of alemtuzumab to this combination.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete physical exam, including routine blood tests (about 3 tablespoons). You may have either a chest x-ray or a computerized tomography (CT) scan if your doctor thinks it is necessary. If you have not had a bone marrow biopsy collected in the past 4 months, you will have a bone marrow sample collected at this time. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anaesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are found to be eligible to take part in this study, you may begin treatment. During this study, you will have up to 6 "cycles" of treatment. A cycle is made up of treatment with the study drugs for 5 days in a row, then around 3 and a half weeks (23 days) of no treatment with the study drugs. On Days 1, 3, and 5 of each cycle, you will receive alemtuzumab through a needle in a vein. On Day 2 of each cycle you will receive rituximab through a needle in a vein. Cyclophosphamide and fludarabine will be given separately on Days 3, 4, and 5 of each cycle through a needle in a vein. In addition to the study drugs, you may also be given premedication and fluids by vein to help decrease the risk of side effects. The premedication may include steroids that are used to decrease the risk of side effects from the alemtuzumab and rituximab. They will be given before each dose of the alemtuzumab and rituximab. The infusions for each daily treatment visit should take less than 6 hours. This treatment will be given on an outpatient basis. The combination treatment will be repeated every 4 weeks (1 cycle) for a total of up to 6 cycles.

You will receive acetaminophen (Tylenol) by mouth and diphenhydramine hydrochloride (Benadryl) by mouth or vein 30-60 minutes before each dose of rituximab and alemtuzumab. You will also receive hydrocortisone (a steroid) by vein before the first dose of alemtuzumab of each cycle. These drugs will be used to help decrease the risk of side effects. If side effects occur during a treatment, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you experience side effects during treatment, you must stay in the clinic to be observed, for 2 hours after the drug is given.

During the treatment and for 2 months after completion of treatment, you will need to take antibiotics to decrease the risk of developing infection.

Trimethoprim/sulfamethoxazole (Bactrim DS, SMX) is a sulfa-drug, and you will be given this to decrease the risk of a type of pneumonia called PCP pneumonia. If you are allergic to sulfa drugs, a similar antibiotic may be given. You will take Valtrex to decrease the risk of potential virus reactivation, including herpes. If you are allergic to Valtrex, a similar antibiotic may be given. You may receive an antibiotic called valganciclovir (Valcyte) to decrease the risk of another virus called cytomegalovirus. You may also take allopurinol for the first week of the first course of treatment. This will help decrease the risk of kidney damage from rapid destruction of your leukemia cells.

During the Cycle 1 of treatment, you will have blood drawn (about 2 tablespoons) for routine blood tests once a week. Then, these blood tests will be repeated before the start of each additional cycle (every 4 weeks). You will also see your treating doctor and provide a history and have a routine physical exam done before each cycle of treatment.

After 3 cycles of treatment, you will have a physical exam and routine blood tests (about 2 tablespoons). You may also have either an x-ray or a CT scan. You will have another bone marrow sample collected. These tests will be used to see if the disease is responding to treatment. If it is found that the disease is not responding to treatment after the first 3 cycles of therapy, you will be taken off the study, and your doctor will discuss other treatment options with you. If it is found that the disease is responding to treatment, another 3 cycles (12 weeks) of treatment will be given. During these additional 3 cycles of therapy, you will have blood drawn (about 2 tablespoons) once a week for routine blood tests.

After 6 cycles of treatment, you will have a physical exam, around 2 tablespoons of blood drawn for routine blood tests, and a bone marrow aspirate and biopsy to determine if your leukemia is in remission.

If your disease gets worse or you experience any intolerable side effects, you will be taken off the study, and your doctor will discuss other treatment options with you.

Around 3-6 months after you receive your last treatment cycle, you will have a physical exam and routine blood tests (about 2 tablespoons). After that, you will have a physical exam and routine blood tests (about 2 tablespoons) every 6 months for the next 2 years. If the leukemia has gone into remission, you will have a bone marrow aspirate and biopsy at 6 months, 1 year, and 2 years after your last treatment cycle, to make sure it stayed in remission. If your disease returns or if you start a new therapy, you will not need to return for these visits. However, you should inform the study doctor/staff that you are receiving other treatment.

This is an investigational study. All of the drugs used in the study are FDA approved and commercially available. Their use together in this study, however, is experimental. As many as 60 patients will take part in the study. All will be enrolled at M.D. Anderson.

CFAR Study in Patients With Chronic Lymphocytic Leukemia

A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in High-Risk Previously Untreated Patients With CLL

Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)\>1,500/uL, Platelets \>100,000uL, Hemoglobin (untransfused) \>11.0g/dL, Lymphocytes \<4,000/uL and Bone Marrow Aspirate biopsy \<30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes \>/= 50% decrease,Liver/spleen \>/= 50% decrease, symptoms not applicable, PMN \>1,500/uL or \>50% improvement from baseline, Platelets 100,000uL or \>/=50% decrease improvement from baseline, Hemoglobin (untransfused) \>11.0g/dL or \>50% improvement from baseline, Lymphocytes \>50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with \<30% lymphocytes with residual disease on biopsy.

Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6.

William G. Wierda, MD/Associate Professor

Nodular partial remission (nPR)

Sixty participants were analyzed for response. Four participants did not have a response and one participant was not evaluable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)	NCT01082939	Chronic Lymphoc...	Fludarabine Cyclophosphamid... Alemtuzumab Rituximab	-	M.D. Anderson Cancer Center
CFAR Study in Patients With Chronic Lymphocytic Leukemia	NCT00525603	Leukemia Chronic Lymphoc...	Cyclophosphamid... Fludarabine Alemtuzumab Rituximab	- 69 Years	M.D. Anderson Cancer Center
Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)	NCT01082939	Chronic Lymphoc...	Fludarabine Cyclophosphamid... Alemtuzumab Rituximab	-	M.D. Anderson Cancer Center
CFAR Study in Patients With Chronic Lymphocytic Leukemia	NCT00525603	Leukemia Chronic Lymphoc...	Cyclophosphamid... Fludarabine Alemtuzumab Rituximab	- 69 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cfar

Every month we try and update this database with for cfar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cfar

Every month we try and update this database with for cfar cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cfar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.