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Leukemia

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Antineoplastic Agents

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Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

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Mycophenolic Acid

Sirolimus

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Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

Fludarabine 40 mg/m2 by vein on Days -8 to -5.

Cyclophosphamide 50 mg/kg by vein on Day -8.

Mesna administered on Day -8 immediately following completion of the Fludarabine.

Total body radiation 2 Gy delivered on Day -4.

3rd party CB Treg infusion on Day -1.

Three (3) participants treated at cell dose level 1: 1 x 10\^6/kg fucosylated T-reg cells. The cells are infused on Day -1.

Cord blood transplant, MRD, or MUD transplant on Day 0.

Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

Fludarabine 40 mg/m2 by vein on Days -8 to -5.

Cyclophosphamide 50 mg/kg by vein on Day -8.

Total body radiation 2 Gy delivered on Day -4.

3rd party CB Treg infusion on Day -1.

Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10\^7/kg T-reg cells. The cells are infused on Day -1.

Cord blood transplant, MRD, or MUD infused on Day 0.

Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

Fludarabine 40 mg/m2 by vein on Days -8 to -5.

Cyclophosphamide 50 mg/kg by vein on Day -8.

Total body radiation 2 Gy delivered on Day -4.

Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10\^7/kg. The cells are infused on Day -1.

Cord blood transplant, MRD, or MUD infused on Day 0.

Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

Fludarabine 40 mg/m2 by vein on Days -8 to -5.

Cyclophosphamide 50 mg/kg by vein on Day -8.

Total body radiation 2 Gy delivered on Day -4.

Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10\^7/kg. The cells are infused on Day -1.

Cord blood transplant, MRD, or MUD infused on Day 0.

Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

Total Body Radiation

Phase I: Participants treated at cell dose level 1: 1 x 10\^6/kg Fucosylated T-reg cells on Day -1.

Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Fucosylated T-reg cells on Day -1.

Fucosylated Regulatory T Cells

Cord blood transplant, MRD, or MUD infused on Day 0.

Cord Blood Infusions

15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

Mycophenolate mofetil

12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

Bone marrow aspiration performed at 1, 3, 6, and 12 months after transplant to check status of disease.

Bone Marrow Aspiration

5 mcg/kg/day subcutaneously beginning on D+0, and continuing until absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

G-CSF

Phase I: Participants treated at cell dose level 1: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1.

Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1.

Non-Fucosylated Regulatory T Cells

Richard E. Champlin, BS, MD

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

T-cells are white blood cells that are important to the immune system. The T cells for this study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you. Before the Tregs are given to you, they may be changed in the laboratory to make use of sugar that is found in small amounts in blood cells through a process called fucosylation. They are then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is designed to help the Tregs find their way faster to the bone marrow, which may help low blood counts to recover faster.

The goal of this clinical research study is to learn if it is safe and practical to give fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result from a reaction of the transplanted cord blood cells against certain tissues in the body.

This is an investigational study. Fucosylation of Tregs is not an FDA-approved process. It is currently being used for research purposes only. Fludarabine, melphalan, cyclophosphamide and rituximab are FDA approved and commercially available to be given to patients with leukemia or lymphoma having a cord blood transplant. Total body irradiation is delivered using FDA-approved and commercially available methods.

Up to 47 patients will take part in this study. All will be enrolled at MD Anderson.

Central Venous Catheter Placement:

You will first have a central venous catheter (CVC) placed. 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 it.

The chemotherapy, some of the other drugs in this study, the Tregs, and the MRD, MUD or cord blood transplant will be given by vein through your CVC. Some blood samples will also be drawn through your CVC. The CVC will remain in your body for about 2-5 months.

Study Treatments:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of Tregs based on when you joined this study. You may receive fucosylated or non-fucosylated Treg cells. Two dose levels of fucosylated Tregs will be tested. Up to 3 participants will be enrolled in Dose Level 1, and up to 17 will be in Dose Level 2. The first group of participants will receive the lower dose level. The next group will receive a higher dose than the first group, if no intolerable side effects were seen.

The next 10 participants will receive non-fucosylated Tregs at Dose Level 2.

The last 34 patients enrolled in the study will be will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups and will have an equal chance of receiving either fucosylated or non-fucosylated Treg cells.

You will receive 1 of 2 preparative regimens before your transplant. These regimens are used to prepare your body to receive the transplant. Your study doctor will decide which regimen is best for you.

Regimen #1:

On Day -12, you will receive rituximab by vein over 4-6 hours, if you are receiving it. This will depend on the disease that you have.

On Day -9, you will be admitted to the hospital and given fluids by vein to hydrate you.

On Day -8, you will receive fludarabine and cyclophosphamide by vein over 1 hour. You will also receive mesna by vein over 30-60 minutes before the cyclophosphamide dose and then every 4 hours for a total of 5 doses. Mesna is given to lower the risk of side effects to the bladder caused by cyclophosphamide.

On Days -7, -6, and -5, you will receive fludarabine by vein over 1 hour.

On Day -4, you will receive a single treatment of low-dose total body irradiation as part of the standard of care for stem cell transplants. You will receive a separate consent form that describes this procedure and its risks.

On Day -1, you will receive the Tregs by vein over 30-60 minutes.

On Day 0, you will receive your stem cell transplant through the CVC over about 30 minutes to several hours depending on the donor type of stem cell transplant you receive.

Regimen #2:

On Day -12, you will receive rituximab by vein over 4-6 hours, if you are receiving it. This will depend on the disease that you have.

On Day -6, you will be admitted to the hospital and given fluids by vein to hydrate you.

On Days -5, -4, -3 and -2, you will receive fludarabine by vein over 1 hour.

On Day -2, you will receive melphalan by vein over 30 mins.

On Day -1, you will receive the Tregs by vein over 30-60 minutes.

On Day 0, you will receive your stem cell transplant through the CVC over about 30 minutes to several hours depending on the donor type of stem cell transplant you receive.

Supportive Drugs:

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff about how the drugs are given and their risks.

Starting on Day -3, you will receive sirolimus by mouth once a day. You will receive mycophenolate mofetil (MMF) as a tablet by mouth 3 times a day.

If you are not able to take the MMF tablet by mouth, you will receive MMF by vein over 2 hours. If you do not have GVHD at Day 100, the dose of MMF will be gradually lowered. If you have GVHD, MMF may be stopped 7 days after the GVHD is controlled. If you do not have GVHD at Day 180 after your transplant, the dose of sirolimus will be gradually lowered. Your doctor will discuss this with you.

You will receive filgrastim as an injection under the skin 1 time a day, starting on Day 0 for cord blood transplant or Day 7 for a matched related or MUD transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.

Study Visits:

As part of standard care, you will remain in the hospital for about 4 weeks after the transplant. After you are released from the hospital, you will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.

On Days -10, -1, 0, +1, +3, +7, +14, +21, and then at 1, 2, 3, 6, and 12 months after the transplant, blood (about 3 tablespoons) will be drawn to check your immune function, response to the T cells, inflammatory responses, and for GVHD markers. If possible, the blood will be collected during standard of care blood draws so that no additional needle sticks will be needed.

About 1, 3, 6, and 12 months after the transplant:

* You will have a physical exam.
* You will be checked for possible reactions to the transplant and study drugs, including GVHD.
* Blood (about 4 teaspoons) will be drawn for routine tests, to check for cytomegalovirus (CMV), and for genetic tests to learn if your body has accepted the donor cells.

Urine will be collected for routine tests.

* If the doctor thinks it is needed, you will have a bone marrow aspiration to check the status of the disease. To collect a bone marrow aspiration/biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
* If you have lymphoma or Hodgkin's Disease and the doctor thinks it is needed, you will have a CT scan of your neck, chest, abdomen, and pelvis to check the status of the disease.

Length of Study:

You will be on study for up to 1 year. You will be taken off study early if the disease gets worse, if intolerable side effects occur, if not enough T cells can be created, if you are unable to follow study directions, or if your doctor thinks it is in your best interest.

Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention

Pilot Study of Infusion of Fucosylated Regulatory T Cells to Prevent Graft Versus Host Disease

Severe infusional toxicity defined according to NCI CTCAE v4.0 (Prolonged (ie, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae. Life-threatening consequences; urgent intervention indicated.)

For the purpose of safety monitoring, "failure" defined as F100 = \[T \< 100 days\]. The Bayesian method of Thall, et al.42 used for safety monitoring.

GVHD or death within 100 days of stem cell transplant estimated using standard Bayesian methods, and summarized by counts and percentages.

National Cancer Institute (NCI)

Cancer Prevention Research Institute of Texas

M.D. Anderson Cancer Center

Primary Myelofibrosis

Hematologic Diseases

Dermatologic Agents

Central Nervous System Depressants

Other Dietary Supplements

Cyclosporine

Cyclosporins

Tacrolimus

Benzocaine

Calcineurin Inhibitors

Tannic Acid

Day -6, -5 Fludarabine 30 mg/M2 IV over 30-60 minutes Cyclophosphamide 14.5 mg/kg IV over 1-2 hours\*, Mesna 14.5 mg/kg IV in 4 divided doses

Day -4 through -2 Fludarabine 30 mg/M2 IV over 30-60 minutes

Day -1 Total Body Irradiation 200 cGy, donor apheresis

Day 0 T cell replete PBSC

Days 3, 4 Cyclophosphamide 50 mg/kg IV Mesna 50 mg/kg IV in 4 divided doses

Day 5 Begin tacrolimus ,mycophenolate, and G-CSF

Fludarabine 30 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2. Fludarabine will be dosed according to the recipient's Adjusted Ideal Body Weight (AIBW) unless AIBW is less than Ideal Body Weight (IBW).

For decreased creatinine clearance (\< 61 mL/min) determined by the Cockcroft Formula:

Cockcroft-Gault CrCl = (140-age) \* (Wt in kg) \* (0.85 if female) / (72 \* Cr)

Fludarabine dosage should be reduced per standard of care.

Pre-transplant

Cy 14.5 mg/kg/day will be administered as a 1-2 hour intravenous infusion with a high volume fluid flush on Days -6 and -5. Cy will be dosed according to the recipient's actual body weight unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the adjusted IBW

Post-transplant

Hydration prior to cyclophosphamide may be given according to Standard Practice Guidelines.

Cyclophosphamide \[50mg/kg\] will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cy will be dosed according to the recipient's actual body weight unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the adjusted IBW. Cyclophosphamide will be given as an IV infusion over 1-2 hours.

.

Pre-transplant

Mesna should be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of mesna is equal to 100% of the total daily dose of cyclophosphamide.

Post-transplant

Mesna should be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of mesna is equal to 100% of the total daily dose of cyclophosphamide.

200 cGy will be administered in a single fraction on Day -1 via linear accelerator.

Total Body Irradiation

Donors who consent to PBSC donation will receive 5 daily doses of G-CSF, 10 μg/kg/day by subcutaneous injection commencing on day -5. PBSC's will be collected in the afternoon of day -1, stored at 4C overnight, and infused as soon as possible on day 0. If the collection on day -1 contains less than 5.0 X 106 CD34+ cells per kg recipient weight, a second collection will be performed the following morning and infused on day 0. Quantitation of CD34 and CD3 cells will be performed by the Cellular Therapy Lab. For all patients, the target number of CD34 cells to be infused should be 5-6 X 106 cells per kg recipient weight. PBSC in excess of 6.0 x 106 CD34 cells/kg recipient weight may be cryopreserved.

Hematopoietic stem cell infusion

Tacrolimus will be given at a dose of .03 mg/kg IV over 24 hours. Tacrolimus will be changed to a PO dosing schedule once a therapeutic level is achieved and the patient is tolerating PO. Whole bloodblood levels of tacrolimus will be measured around Day 7 and then should be checked at least weekly thereafter and the dose adjusted accordingly to maintain a level of 5-10 ng/mL. Tacrolimus will be discontinued after the last dose around Day 180, or may be continued if active GVHD is present. Cyclosporine (target concentration 200-400 ng/ml) may be substituted for tacrolimus if the patient is intolerant of tacrolimus.

Either the sodium salt of mycophenolate or mycophenolate mofetil (MMF) may be used as prophylaxis of GvHD and will be dosed by actual bodyweight. Only MMF is available as IV formulation. Sodium mycophenolate will be given at a dose of 10mg/kg PO TID rounded to the nearest number of 180mg tablets. MMF will be given at a dose of 15 mg/kg PO TID. The maximum total daily dose should not exceed 2160 mg (sodium salt) or 3 grams (mofetil). Mycophenolate prophylaxis will be discontinued after the last dose on Day 35, or may be continued if active GVHD is present.

Mycophenolate

G-CSF will be given beginning on Day 5 at a dose of 5 mcg/kg/day (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is \> 1,000/mm3 for three consecutive days.

Rafic J Farah, MD

The purpose of this study is to determine whether stem cells collected from a donor's blood stream will be as safe and effective as using bone marrow collected from a donor's pelvic bone.

This is a pilot study to assess the safety and potential efficacy of haploidentical peripheral blood stem cell transplantation using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide. The overall objective of this study is to collect the efficacy and safety data to provide the basis to decide whether a larger study of clinical efficacy is warranted in this setting.

Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source

The cumulative incidence of grades III/IV acute GvHD at day +84 will be assessed. The first day of acute GvHD onset will be used to calculate a cumulative incidence curve by certain grade. An overall cumulative incidence curve will be computed along with a 90% CI with graft failure, relapse/progression, and death as competing risks.

The cumulative incidence of chronic GvHD at one year will be assessed. An overall cumulative incidence curve will be computed along with a 90% CI with graft failure, relapse/progression, and death as competing risks.

The cumulative incidence of NRM at 1 year will be assessed. An overall cumulative incidence curve will be computed along with a 90% CI with relapse/progression as competing risk.

The cumulative incidence of relapse at 1 year will be assessed. An overall cumulative incidence curve will be computed along with a 90% CI with NRM as competing risk.

Achievement of an ANC ≥ 500/mm3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.

Primary graft failure \< 5% donor CD3 chimerism

Initial recovery followed by neutropenia with \< 5% donor chimerism.

The first day of a sustained platelet count \>20,000/mm3 with no platelet transfusions in the preceding seven days.

Donor chimerism \>= 50% on day \>= 84 after transplantation. Donor engraftment also should be tested on day +28.

Progression-free survival is the minimum time interval to relapse/recurrence, to death or to last follow-up.

Infections will be reported by anatomic site, date of onset, organism and resolution, if any.

Rafic Farah, MD

Assistant Professor of Medicine

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Everolimus

Prednisolone

Methylprednisolone

Basiliximab

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glycyrrhetinic Acid

Protein Kinase Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

Simulect + cyclosporine + Myfortic + steroid stop at 3 months

Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance

Cyclosporine (Group 1):

basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4

Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.

C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml

Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.

Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.

Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop

cyclosporine

Everolimus (Group 2):

Basiliximab dose: idem as in group 1

Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.

Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.

Enteric-coated mycophenolate (MPA) dosing idem as group 1.

Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.

Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60.

Jean-Louis Bosmans, MD/PhD

Daniel Abramowicz, MD/PhD

Jacques Sennesael, MD/PhD

Jacques Sennesael, MD

Angelika Jurgens, Study Coord.

Patrick Peeters, MD/PhD

Patrick Peeters, MD

Catherine Bonvoisin, MD/PhD

Catherine Bonvoisin, MD

This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events.

The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

Methodology:

* A 5-year, multicentre, prospective, randomized, open-label, controlled study

  * Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months
  * Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance.
* In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection.

Sample size calculations:

A total of 152 patients will be randomized (76 patients per group)

Population:

De novo kidney transplant recipients.

Study duration:

1.5 years inclusion+ follow-up during the first 5 years

Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention	NCT02423915	Leukemia Lymphoma	Rituximab Fludarabine Cyclophosphamid... Total Body Radi... Fucosylated Reg... Cord Blood Infu... Mycophenolate m... Sirolimus Bone Marrow Asp... G-CSF Non-Fucosylated...	18 Years - 80 Years	M.D. Anderson Cancer Center
Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source	NCT02167958	Leukemia MDS Myelofibrosis Lymphoma	Fludarabine Cyclophosphamid... Mesna Total Body Irra... Hematopoietic s... Tacrolimus Mycophenolate G-CSF	18 Years - 70 Years	University of Pittsburgh
Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention	NCT02423915	Leukemia Lymphoma	Rituximab Fludarabine Cyclophosphamid... Total Body Radi... Fucosylated Reg... Cord Blood Infu... Mycophenolate m... Sirolimus Bone Marrow Asp... G-CSF Non-Fucosylated...	18 Years - 80 Years	M.D. Anderson Cancer Center
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation	NCT00903188	Renal Transplan...	cyclosporine Everolimus	18 Years -	University Hospital, Antwerp

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