Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Hematologic Neoplasms

Lymphoproliferative Disorders

Paraproteinemias

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Alemtuzumab

Antineoplastic Agents, Immunological

FLUDARABINE

CAMPATH 1H

FK50

Stem Cell Collection and Infusion

George Carrum, MD

1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.

The following will be given to the patient after admission:

Day - 6: Total body irradiation

Day - 5 to - 2: Fludarabine and Campath 1H

Day - 1: Day of rest

Day 0: Stem cell transplant (infusion)

Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Baylor College of Medicine

Professor

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Neoplasm Metastasis

Syndrome

Congenital Abnormalities

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Total Body Irradiation Fludarabine Campath 1H

Total body irradiation of 450cGy as a single dose, day -6

Total Body Irradiation

Campath 1H dosing as per institutional SOPs Day -5 to -2

Campath 1H

Patients are being asked to participate in this study because they have a malignant blood disease such as Myelodysplastic Syndrome (MDS), Myeloproliferative Disorder (MPD), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia (CML). We feel that patients could benefit from an allogeneic (meaning the cells come from a donor other than themself) stem cell transplant. The donor would be a family member or an unrelated person that is felt to be a good match for the patient. Stem cells are cells that are made in the bone marrow (spongy material that fills the middle of the bones). As the stem cells grow, they change into different types of blood cells that they need. This includes red blood cells that carry oxygen around the body, white blood cells that help to fight infections, and platelets that help to prevent and stop bleeding. Usually, patients are given high doses of chemotherapy before a stem cell transplant. High doses of chemo destroy the bone marrow. Healthy stem cells from a donor are then given to replace the patient's unhealthy cells. However, because of complications with the patient's disease, they have a high risk of having life-threatening side effects. These include serious damage to organs such as the lung, liver, kidney and heart. There is also an increased risk of bacterial, fungal, and viral infections. The other major problem is when a donor's stem cells (also called the graft) find that the patient's cells ( the host cells) are not the same. The donor cells may try to destroy the host's cells. The cells at high risk are those of the skin, liver and intestines. This is called graft versus host disease (GVHD) and it can be fatal.

Recently, doctors have been able to use less toxic chemotherapy treatments before patients receive their transplants. This less toxic treatment helps reduce some of the treatment related problems mentioned above. Patient's are being asked to be involved in a research study that uses this approach. One major risk of this low dose treatment is that the patient's body may reject the donor cells. This is called graft rejection. This study is designed to see if this low dose treatment is safe and effective.

This treatment plan adds CAMPATH 1H (a special protein called an antibody) to a low dose chemotherapy regimen. After chemo, the patient will receive an allogeneic (cells come from a donor) stem cell transplant. Adding CAMPATH 1H to the transplant medicines may help in treating the disease. CAMPATH 1H may reduce life-threatening and treatment related side effects like GVHD. CAMPATH 1H stays active in the body for a long time which means it may work longer to prevent GVHD. CAMPATH 1H destroys lymphocytes, a type of white cells that help fight infection, and this helps prevent graft rejection.

We want to see if the addition of CAMPATH 1H to the patient's pre-transplant low dose chemotherapy will decrease the side effects from an allogeneic stem cell transplant, while providing a curative treatment for patients with blood disorders.

We expect that the patient's participation in this study will last approximately 18 months to 2 years.

Before treatment begins, they will be evaluated to confirm they meet the requirements of this study. The evaluation includes HIV testing, HIV (Human Immunodeficiency Virus) is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). If the patient is HIV positive, they will not be able to be treated on this protocol.

The patient will need to have a central line. This is a thin plastic catheter or tube that is placed during surgery into one of the large veins in the chest or neck. Central lines are used to give medications IV (intravenous, by vein) or to take blood samples without having to endure frequent needle sticks.

After admission to the hospital the subject will receive:

Day -6: a single dose of total body irradiation

Day -5 to Day -2 Chemotherapy: Fludarabine plus Campath 1H through a catheter inserted into a vein (IV)

Day -2: FK506 given IV over a 24 hour period until the patient can take medication by mouth. When they can take oral medication they will take this medication by mouth every 12 hours.

Day -1 : a day of rest

Day 0: the stem cell transplant (infusion) will be given

Day +7: G-CSF will be given by subcutaneous injection until your white blood cells (granulocytes) are greater than 1000/ul.

After transplantation, they will be evaluated as follows. Routine history, physical examination, blood tests and radiology studies will be done as needed for clinical care. Bone marrow aspirate and biopsy will be done on or about day 30, 60 and 100, 180 and then yearly and as needed.

Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Stem Cell Transplant in Treating Patients With Myeloproliferative Disorder, MS, AML, or CML

Safety And Efficacy of Sub-Myeloablative Allogeneic Stem Cell Transplantation For Patients With Myeloproliferative Disorder (MPD), Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia

Safety and feasibility of submyeloablative conditioning as a preparative regimen for blood stem cell transplantation

Associate Professor; Director-Adult Outpatient Clinic

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Cyclosporine

Cyclosporins

Tacrolimus

Immunosuppressive Agents

Immunologic Factors

Calcineurin Inhibitors

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.

Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.

Stem Cell Transplant

Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.

Total Body Irradiation (TBI)

Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.

FK506 (Tacrolimus) or Cyclosporine

Patients are being asked to participate in this study because they have a cancer in their blood, Fanconi's Anemia, or have been unsuccessfully treated for bone marrow failure such as Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria. Any of these conditions could benefit from an allogeneic stem cell transplant using a donor that is related to the patient.

Stem cells are created in the bone marrow. They grow into different types of blood cells that the patient needs, including red blood cells, white blood cells, and platelets. In a transplant, the patient's own stem cells are killed and then replaced by stem cells from the donor.

Usually, patients are given very strong doses of chemotherapy prior to receiving a stem cell transplant. However, because of the patient's condition, they have a high risk of experiencing life-threatening treatment-related side-effects. Recently, some doctors have begun to use chemotherapy that does not cause as many side-effects before patients receive a transplant.

This research study adds CAMPATH 1H to a low-dose chemotherapy regimen, followed by an allogeneic stem cell transplantation. We want to see whether adding CAMPATH 1H to the transplant medications helps in treating the disease. We also want to see whether there are fewer life-threatening side-effects from the treatment. CAMPATH 1H is a drug that is still being studied. CAMPATH 1H stays active in the body for a long time after patients receive it, which means it may work longer at preventing graft-versus-host-disease (GvHD) symptoms.

Before treatment begins, stem cells will be collected from the donor's blood or bone marrow. The stem cells will be collected and frozen before we start to give the patient chemotherapy.

After admission to the hospital, patients will receive total body irradiation (very strong x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the stem cell transplant (infusion of the donor's stem cells).

Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous injection, until a blood test shows that numbers of granulocytes (a type of white blood cell) in the blood are more than 1,000/uL. This is to help increase blood cell counts.

After transplantation, the patient will undergo several evaluations at different times. These are standard evaluations and tests performed for any patient who has received a stem cell transplant, as part of routine clinical monitoring.

We will also be looking at the patient's immune function (how the body protects itself to prevent and fight infections and diseases). To do this, blood tests will be performed at regular intervals (every 3 to 6 months) for 2 years.

Depending on how well the donor stem cells work in the body after the transplant, the patient may receive one or more Donor Leukocyte Infusions (DLI). This is when leukocytes (a type of white blood cell) collected from the same donor that provided the stem cells are given to the patient through a central line into a vein.

Stem Cell Transplant for Hematologic Diseases

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H

Percentage of patients with transplant related mortality

Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10\^9/L on the first of 3 days.

Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days

Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant

Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant

Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method.

Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method.

Principal Investigator

Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.

Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.

Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.

Stem Cell Transplant: Day 0: Donor stem cells infused.

Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.

FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H	NCT00048412	Myelodysplastic... Leukemia Multiple Myelom... Plasma Cell Dys... Lymphoprolifera...	FLUDARABINE CAMPATH 1H FK50 Stem Cell Colle...	- 70 Years	Baylor College of Medicine
Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Stem Cell Transplant in Treating Patients With Myeloproliferative Disorder, MS, AML, or CML	NCT00069992	Chronic Myelopr... Leukemia Myelodysplastic...	Total Body Irra... Fludarabine Campath 1H	-	Baylor College of Medicine
Stem Cell Transplant for Hematologic Diseases	NCT00058825	Hematologic Mal...	Campath 1H Fludarabine Stem Cell Trans... Total Body Irra... FK506 (Tacrolim...	- 70 Years	Baylor College of Medicine
Stem Cell Transplant for Hematologic Diseases	NCT00058825	Hematologic Mal...	Campath 1H Fludarabine Stem Cell Trans... Total Body Irra... FK506 (Tacrolim...	- 70 Years	Baylor College of Medicine

Spots Global Cancer Trial Database for campath 1h

Every month we try and update this database with for campath 1h 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 campath 1h

Every month we try and update this database with for campath 1h 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 campath 1h 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.