Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Leukemia

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Graft vs Host Disease

Hematologic Diseases

Lymphosarcoma

Homologous Wasting Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Busulfan

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.

Starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.

Dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.

Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.

Amin Alousi, MD

The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.

The Study Drugs:

Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die.

Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. It is also designed to suppress the immune system and help prevent GVHD.

Study Drug Administration and Transplant:

If you are an inpatient, on Day -8 (8 days before the date of transplant), you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour.

If you are an outpatient, on Day -30 through Day -8, you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour each day.

You will be given an anti-seizure drug to help prevent seizures each time you receive busulfan. Your doctor will explain how the drug will be given and the drug's risks. Seizures are a rare but serious side effect of busulfan.

On Days -8, -6, and -4, blood (about 1 teaspoon each time) will then be drawn a total of 11 times for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. This PK testing will be done to find the dose of busulfan needed for your body size on the other days that you receive busulfan.

On Day -6 through Day -3, you will receive your body-specific dose of busulfan by vein over 3 hours each day. If you cannot have the blood level tests performed for any reason, you will receive the standard busulfan dose. You will receive fludarabine through a needle in your vein over 1 hour on each of these days before you receive busulfan.

On Day 0, you will receive the donor bone marrow or blood stem cells by vein over about 1 hour.

On Day +3 and Day +4, you will receive cyclophosphamide by vein over 3 hours.

On Days +3 thru +5 just before the first dose of cyclophosphamide and then every 4 hours, you will receive mesna by vein over 30 minutes for a total of 10 doses. Mesna is a drug that protects bladder cells from damage by chemotherapy drugs. It is used to decrease the risk of bleeding in the bladder.

Once a day starting on Day +7, you will receive filgrastim (G-CSF -- a drug that helps with the growth of white blood cells) through a needle under your skin until your blood cell levels reach "recovered" levels for 3 days in a row.

Study Visits:

Every day you are in the hospital and at each outpatient visit, you will have a physical exam to check for symptoms of GVHD.

Blood (about 3 teaspoons) will be drawn at least 2 times a week for the first 100 days after the transplant for routine tests.

About 1 month after your transplant, then once every 3 months up to a year, the following tests and procedures will be performed:

* Blood (about 5 tablespoons) will be drawn for routine tests and to check for CMV. Blood draws may be repeated more often, if you doctor thinks it is needed.
* Urine will be collected for routine tests.
* You will have a bone marrow aspirate and biopsy to check the status of the disease.

At Months 1, 2, 3, 6, and 12 after your transplant, blood (about 4 tablespoons) will be drawn to check the status of your immune system.

Tests and procedures may be repeated more often during the study, if your doctor thinks it is needed.

Length of Study:

You will be on study in the hospital for about 4 weeks. You will be taken off study if the disease gets worse or if the study doctor thinks it is in your best interest.

Long-Term Follow-Up:

After the first 24 months, you will receive either a phone call or a letter from the study doctor or your regular doctor 1 time each year to check the status of the disease. If you are contacted by mail, you will be given a self-addressed stamped envelope with which you can return your responses to the doctor.

This is an investigational study. Busulfan is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). Cyclophosphamide is FDA approved and commercially available for the treatment of lymphoma. The use of these drugs together for the possible prevention of GVHD is investigational.

Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.

Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.

Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.

Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.

Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.

Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.

Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.

Overall Survival (OS) is defined as the interval between day of transplant and day of death.

M.D. Anderson Cancer Center

Busulfan + Fludarabine + Cyclophosphamide

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Amin M. Alousi, MD/Stem Cell Transplantation

Cumulative Incidence of Grade II to IV Acute GVHD

Cumulative Incidence of Grade III to IV Acute GVHD

Day-100 Treatment-Related Mortality

Rate of Engraftment

2-year Progression-Free Survival

2-year Overall Survival

Overall Study

Symptoms and General Pathology

Syndrome

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Chronic Graft Versus Host Disease

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Plerixafor

Lenograstim

Thymoglobulin

Antilymphocyte Serum

Antiviral Agents

Anti-HIV Agents

Anti-Retroviral Agents

ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

ATG + MTD Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.

Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I

Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.

Filgrastim

Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days.

Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine.

Allogeneic blood stem cell transplant

Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.

ATG (Thymoglobulin)

Marina Konopleva, MD, PhD

The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).

The Study Treatment:

Fludarabine is a chemotherapy drug that is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.

Busulfan is a chemotherapy drug that is designed to bind to DNA, which may cause cancer cells to die. It is commonly used in stem cell transplants.

Plerixafor and filgrastim are designed to cause cancer cells to move from the bone marrow into the blood stream. This may help to make the cancer cells more sensitive to being killed by the chemotherapy.

An "allogeneic" (from a donor) stem cell transplant is designed to help the recipient's body attack the cancer cells that may remain in the body after chemotherapy.

Study Groups and Plerixafor Dose Levels:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 4 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 48 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of plerixafor you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of plerixafor. Each new group will receive a higher dose of plerixafor than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of plerixafor is found.

If you are enrolled in Phase II, you will receive plerixafor at the highest dose that was tolerated in the Phase I portion.

In this study, plerixafor is the only study drug where different dose levels are being tested and compared.

Drug Administration Before the Transplant:

You will receive your first dose of filgrastim on Day -9. (Day -9 means 9 days before the stem cell transplant, which will occur on Day 0).

Filgrastim is injected under the skin once a day from Day -9 through Day -4. Plerixafor is injected under the skin once a day from Day -7 through Day -4. The plerixafor injections will occur 8 hours before the fludarabine and busulfan chemotherapy.

The fludarabine and busulfan will be given by vein through a central venous catheter (CVC). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.

Fludarabine is given once a day from Day -6 through Day -3, over 1 hour each time. On these same days, busulfan will be given after the fludarabine, over 3 hours.

You will also receive tacrolimus in order to lower the risk of graft vs. host disease (GVHD). GVHD is a disease that occurs when the donor's immune cells react against the recipient's body, attacking the recipient's cells and tissues.

Starting on Day -2, tacrolimus will be given as a continuous (non-stop) infusion through the CVC. When the study doctor decides it seems safe, you will begin taking tacrolimus by mouth instead, for as long as the study doctor decides is necessary.

If your stem cell donor is not someone who is related to you, you will receive antithymocyte globulin (ATG) through the CVC once a day from Day -3 through Day -1. On Day -3, it will be given over at least 6 hours. On Days -2 and -1, it will be given over at least 4 hours. This drug is given in order to weaken your immune system in order to lower the risk of your immune system rejecting the transplanted cells.

Blood Tests Before the Transplant:

If you are in the Phase I part of this study, the following blood samples will be drawn and are not optional. Eight total blood samples (about 1 1/2 teaspoons each) will be drawn daily with your routine morning labs beginning before your first dose of study therapy (or Day -9) through Day -3. These samples will be used for research purposes, to study how the chemotherapy drugs and transplant may affect your normal cells and cancerous cells.

If you are in the Phase II part of the study the following blood samples are optional and if you agree, eight total blood samples (about 1 1/2 teaspoons each) will be drawn daily beginning before your first dose of study therapy (or Day -9) through Day -3. These samples will be used for research purposes, to study how the chemotherapy drugs and transplant may affect your normal cells and cancerous cells.

Stem Cell Transplant:

On Day 0, after 2 days of rest from chemotherapy, the donor's stem cells will be given to you by vein (through the CVC). This should take about 30-60 minutes.

Drug Administration After the Transplant:

In addition to continuing to receive tacrolimus to lower the risk of GVHD (as described above), after the transplant you will also receive methotrexate to lower the risk of GVHD. Methotrexate will be given by vein, through the CVC, over 15 minutes on Days 1, 3, and 6. It will also be given on Day 11 if your stem cell donor is someone who is not related to you.

Once a day, starting at 1 week after the transplant, you will receive filgrastim as an injection under your skin. These daily injections will continue until your blood counts recover.

Reasons for Stopping the Study Treatment Early:

If you experience intolerable side effects or the disease gets worse during study treatment, you will be taken off the study treatment.

Other Procedures After the Transplant:

You will remain in the hospital until your blood counts recover (usually about 4 weeks after the transplant). You will continue being monitored for any infections and transplant-related side effects for at least 100 days after the transplant.

At 1, 3, 6, and 12 months after the transplant, you will have blood tests (about 3 tablespoons) and bone marrow biopsies performed to check the status of the disease.

Length of Study Participation:

Your active participation in this study will be over at 12 months after the transplant. The study staff will continue to contact your local doctor regularly from then on. The purpose is to check the status of the disease and see how you are doing.

Up to 72 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson.

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias

Phase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).

In Phase II portion of study, number of participants with treatment failure defined as either disease recurrence or death, measured from start of treatment to allo transplant at Day 0.

Number of participants with complete chimerism at day 30 where defined as: Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC \>0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC \<0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.

Genzyme, a Sanofi Company

ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant:

Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)

Phase I Plerixafor + G-CSF

Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.

Phase II Plerixafor 240 mcg/kg + G-CSF

Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)

Total

Marina Konopleva, MD, PhD / Associate Professor

0 mcg/kg daily

80 mcg/kg daily

160 mcg/kg daily

240 mcg/kg daily

ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)

Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.

Fludarabine : Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days.

ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.

Busulfan : Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine.

Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.

Two participants of 18 registered left the study without receiving Plerixafor treatment and there were not available for MTD analysis.

Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor

Participants in

Participants not in Complete Remission

Plerixafor escalating doses 0, 80, 160, 240 mcg/kg or MTD 240 mcg/kg given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)

Overall Study: Plerixafor + G-CSF

Participants treated in the Phase 1 portion of the trial at the selected MTD dose were counted toward the maximum subgroup sample in Phase 2, therefore four of Phase I participants were included having received the MTD Plerixafor dose; however, one late participant in Phase 2 was not evaluable for the outcome.

Number of Participants Alive With no Disease Progression at Time of Allo Transplant

There were 39 participants receiving first transplants for acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) of both Phase I and Phase II who received MTD dose and allo transplant thus were evaluable for outcome.

Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30

Bone Marrow Diseases

Precancerous Conditions

Dermatologic Agents

Reproductive Control Agents

Analgesics

Micronutrients

Hematinics

Vitamins

Aldesleukin

Methotrexate

Tacrolimus

Interleukin-2

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Calcineurin Inhibitors

Analgesics, Non-Narcotic

Folinic Acid

Folate

Vitamin B9

Thymoglobulin 1.5 mg/kg by vein for 3 days. Busulfan 130 mg/m\^2 by vein for 4 days. Fludarabine 40 mg/m\^2 by vein for 4 days. Alloreactive NK infusion from haploidentical donor on Day -8. Alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7 NK Cells plus systemic interleukin-2 treatment. The 4th dose level is 3 x 107 NK cells/kg plus systemic interleukin-2 at a dose of 0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4.

G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count is \> 500 x 109/L for 3 consecutive days. Tacrolimus starting dose of 0.015 mg/kg daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present. Methotrexate 5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant.

130 mg/m\^2 By Vein Over 3 Hours x 4 Days

40 mg/m\^2 By Vein Over 30 Minutes x 4 Days

Alloreactive NK infusion from haploidentical donor on Day -8. The alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7.

Alloreactive NK Infusion

5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is \> 500 x 109/L for 3 consecutive days.

G-CSF

Starting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present.

5 mg/m2 intravenously on Days 1, 3 and 6 and Day +11 post transplant.

0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4 only to participants receiving fourth dose level of NK cells.

Richard E. Champlin, MD

The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours who has certain genetic type in their blood called HLA, that almost matches yours. The stem cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or unrelated donor. The safety of this treatment will also be studied.

NK cells are part of the immune system (the cells in your body that fight disease). Sometimes, NK cells react against and fight leukemia cells that are mismatched with your body for certain HLA tissue type proteins. When the NK cells react, these cells are called "alloreactive NK cells."

In this study, researchers will collect alloreactive NK cells from the blood of a relative of yours whose HLA proteins do not match yours exactly. The NK cells are separated from the blood using a machine called a CLINIMACs system. This machine uses special kinds of cells and magnetic beads to separate the NK cells. The drug interleukin-2 is then added to the NK cells, to improve their function. The interleukin-2 will be washed out of the cell sample before it is given to you. The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.

If you are able to take part in this study, you will receive high-dose chemotherapy for 4 days. You will receive fludarabine over about 30 minutes daily as an intravenous (IV--through a needle in your vein) infusion . You will also receive busulfan over 3 hours by IV once a day. About 2 days later, you will be given the infusion of the alloreactive NK cells by IV. Patients will receive one of 3 dose levels. Some patients will receive interleukin-2 daily for 4 days to enhance the function of the NK cells.

Five (5) days after the NK cell infusion, thymoglobulin will be given to you by IV daily for 3 days. Thymoglobulin is an immunosuppressive treatment to reduce the risk of graft rejection. Then blood stem cells will be administered IV from a different stem cell donor whose HLA type matches yours.

You will receive the drugs tacrolimus and methotrexate to help lower the risk of a reaction called "graft-vs.-host disease" (GVHD). GVHD is when the donated immune cells in the transplant react against the body of the person receiving the cells. Tacrolimus will be given by IV for about 2 weeks, and after that it is given by mouth as a pill for at least 3 months. Methotrexate will be given as an IV injection for 3 to 4 doses over the first 11 days after the stem cell transplant.

You will also receive the drug G-CSF (Neupogen) as an injection under the skin until your blood cell counts reach a certain high enough level.

You will need to stay in the hospital for about 4 weeks. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for at least 100 days after the transplant.

You will be asked to come back to the clinic at 3, 6, and 12 months after your transplant for routine safety testing. This will include a physical exam, a bone marrow biopsy, and routine blood draws.

This is an investigational study. The way the researchers make the alloreactive NK cells using the CLINIMACs device is investigational. The CliniMACS device is not FDA approved. At this time, it is being used in research only. Up to 18 patients will take part in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	NCT00800839	Hematologic Dis... Leukemia Lymphoma Myeloma	Busulfan Fludarabine Cyclophosphamid...	6 Months - 75 Years	M.D. Anderson Cancer Center
Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin	NCT00822770	Stem Cell Trans... Leukemia	Plerixafor Filgrastim Fludarabine Busulfan Allogeneic bloo... ATG (Thymoglobu...	18 Years - 65 Years	M.D. Anderson Cancer Center
Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin	NCT00822770	Stem Cell Trans... Leukemia	Plerixafor Filgrastim Fludarabine Busulfan Allogeneic bloo... ATG (Thymoglobu...	18 Years - 65 Years	M.D. Anderson Cancer Center
Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)	NCT00402558	Myelodysplastic... Leukemia	Thymoglobulin Busulfan Fludarabine Alloreactive NK... G-CSF Tacrolimus Methotrexate Interleukin-2	- 70 Years	M.D. Anderson Cancer Center
Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)	NCT00402558	Myelodysplastic... Leukemia	Thymoglobulin Busulfan Fludarabine Alloreactive NK... G-CSF Tacrolimus Methotrexate Interleukin-2	- 70 Years	M.D. Anderson Cancer Center
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	NCT00800839	Hematologic Dis... Leukemia Lymphoma Myeloma	Busulfan Fludarabine Cyclophosphamid...	6 Months - 75 Years	M.D. Anderson Cancer Center
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	NCT00800839	Hematologic Dis... Leukemia Lymphoma Myeloma	Busulfan Fludarabine Cyclophosphamid...	6 Months - 75 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for myleran®

Every month we try and update this database with for myleran® 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 myleran®

Every month we try and update this database with for myleran® 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 myleran® 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.