Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Myeloproliferative Disorders

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Cytarabine

Cyclophosphamide

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Antiviral Agents

patient's will be recieving a stem cell transplant on study Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation

3000 mg/m\^2 - pts will recieve via IV every 12 hours for 6 doses starting at 20:00 hours on day -8

Ara C

45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide

45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours

Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4

TBI-Total Body Irradiation

Robert Krance, MD

Patients are being asked to participate in this study because they have a cancer in their blood (such as leukemia or lymphoma) or myelodysplastic/myeloproliferative (pre-leukemia). We suggest a treatment that might help them live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help the patient as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells than we could give without the transplant. We also think that the healthy cells may help fight any diseased cells left after the transplant.

Stem Cells are special "mother" cells that are found in the bone marrow (the spongy tissue inside bones), although some are also found in the bloodstream (peripheral blood). As they grow, they become either white blood cells which fight infection, red blood cells which carry oxygen and remove waste products from the organs and tissues or platelets, which enable the blood to clot. For the transplant to take place, we will collect these stem cells from a "donor" (a person who agrees to donate these cells) and give them to the patient. The patient has a type of blood cell cancer or other blood problem that is very hard to cure with standard treatments and they will receive a stem cell transplant (SCT). If they have a brother or sister that is a perfect match and agrees to donate, the stem cells will come from him/her. Before the transplant, two very strong drugs plus total body irradiation will be given to the patient (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin producing blood cells that will eventually mature into healthy red blood cells, white blood cells and platelets.

Also, we will ask permission to draw blood from the patient so that we can measure the number of certain blood cells called T regulatory cells. T regulatory cells are special immune cells that can control or regulate the body's immune response. We want to determine whether T regulatory cells are important participants in graft versus host disease (GVHD), infection and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the body of the transplant patient (the host). GVHD can affect many different parts of the body. The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to life-threatening. We do not know whether T regulatory cells can modify these conditions. We want to measure these T regulatory cells and learn if these cells do influence these conditions. If we learn that T regulatory cells do affect these conditions, then it may be possible to modify these cells for the benefit of transplant patients.

Before the transplant we will test the patients blood for viruses which can cause problems after the transplant. These viruses include Hepatitis B, (which causes liver damage), cytomegalovirus, (which causes lung disease) and HIV (which causes AIDS). If the patient is positive for the AIDS virus, they will not be able to undertake the transplant.

The patient will be given 6 doses of chemotherapy with a drug called Ara C in high doses (every 12 hours) which will begin 8 days before their stem cell transplant. Then, another chemotherapy drug called cyclophosphamide will be given in high doses by vein for two days on the 7th and 6th days before their transplant. A drug called MESNA will be given with cyclophosphamide. MESNA is used to decrease the side effects caused by cyclophosphamide. Radiation treatment will be given to the entire body on each day for 4 days before the transplant. This will be done 2 times a day for 4 days. The chemotherapy and radiation treatment will last 8 days. The patient will receive extra radiation treatment if they have certain diseases (central nervous system (CNS) disease, testicular disease or other focal (localized) disease).

The day after the radiation treatment is completed; the patient will receive the healthy stem cells by vein. Once in the bloodstream, these stem cells will go to the bone marrow and should begin to grow

In prevention of GVHD, the patient will also receive medicine called FK506 as well as low dose methotrexate. The FK506 will be given intravenously (through the vein) initially starting 2 days before the transplant and later by mouth (when they are able to take oral medications). This drug will be given each day for several weeks. Four doses of low dose methotrexate will be given intravenously. The methotrexate will be given on the day after the transplant, 3, 6 and 11 days after the transplant. If the GVHD cannot be controlled with FK506, other medicines may need to be given. Your doctor will describe these medicines at that time.

After the patient has their stem cell transplant, we would like to collect some blood at different time points after the transplantation in order to study how regulatory T cells work and grow after a stem cell transplant.

To study how these cells are working in the system, blood samples will be taken each month for six months, at nine months, at one year, 2 years and 3 years following transplant. Approximately 6-8 teaspoons of blood will be collected each time. The total blood drawn for this study over three years should not exceed 1 and 3/4 cups. This amount is considered safe in adults. The amount of blood collected will be decreased in children and/or in patients where this amount of blood collection would not be appropriate. If the patient has a central line, the blood will be taken from it, so that extra needle sticks should not be needed. If the patient does not have a central line, they will need to have one placed. This will be a separate procedure for which the patient will sign a separate consent form. The patient will need to come to the clinic on the days of blood drawing and to be seen at Texas Children's Cancer Center.

T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE

T-Regulatory Cell Kinetics Post Transplant For Patients Undergoing Matched Sibling Stem Cell Transplantation

The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.

Baylor College of Medicine

Professor

All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.

Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m\^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0.

Stem Cell Transplant

All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

A total of 26 patients were enrolled on the study and all of them received the conditioning treatment and the transplant.

All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.

Only 20 of the 26 patients enrolled were included in this analysis as only 20 patients have Treg values at 1 year.

Median Percentage of Treg Cells at 1 Year Post Transplant

All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.

Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m\^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.

Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0.

Overall Study

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Etoposide

Cisplatin

Prednisolone

Etoposide phosphate

Brentuximab Vedotin

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

1. - 3 cycles every 21 days:

   * Brentuximab Vedotin, on day 1 (BV will be administered at three different doses 0.9mg/kg, 1.2mg/kg, 1.8mg/kg)
   * Etoposide 40 mg/m2/day, on days 1 to 4
   * Soludomerin (methylprednisolone) 250 mg/day, on days 1 to 4
   * Cisplatin 25 mg/m2/day, on days 1 to 4
   * Ara C (cytarabine) 2 g/m2, on day 5
2. - A fourth dose of BV will be given 21 days after the third BV dose during the evaluation of response before the transplant.
3. - Autologous peripheral blood stem cell transplant
4. - A fifth dose of BV (1.8mg/kg) will be given on between day 28 and 35 post-transplant, followed by two additional doses (1.8mg/kg) every 3 weeks, to complete a total of 7 BV infusions.

Brentuximab Vedotin, 0.9mg/kg, 1.2mg/kg, 1.8mg/kg, day 1

Intravenose use, 40mg/m2/day, on days 1 to 4

Intravenous use, 250mg/day, on days 1 to 4

Soludomerin

Intravenous use, 25mg/m2/day, on days 1 to 4

Ramón García-Sanz, MD

Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.

Most patients suffering from Hodgkin's lymphoma (HL) can be successfully treated with standard chemo- and/or radiotherapy. However, in patients with refractory disease/relapsing after first line of therapy, conventional-dose chemotherapy regimens induce low remission rates, with long-term disease free survival not higher than 10% of patients.

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard treatment for these patients. This treatment approach results in long-term remissions in approximately 40-50% of relapsed patients, and in up to 25-30% of those with primary refractory disease. The possibility of a cure depends on several prognostic factors, however, in almost all series, the strongest prognostic factor has been the disease status before ASCT. Patients with HL who do not achieve complete remission (CR) after induction chemotherapy and those with unresponsive relapse have a very poor prognosis. Therefore, the choice of a very active pre-transplant salvage chemotherapy regimen is extremely important to improve results after ASCT. In addition, this activity should also be combined with a good stem cell mobilizing potential and low toxicity profiled.

Several pre-transplant salvage regimens for refractory/relapsed HL are currently used with an overall response (OR) and CR rates ranging from 60% to 88% and from 17% to 49%, respectively. No randomized trial exists comparing the effectiveness of these regimens. ESHAP (Etoposide, Solumoderin (methylprednisolone), Ara-C (Cytarabine) and cisplatin) is one of the most commonly used regimens. ESHAP induces an OR and CR of 73% and 41%, respectively, with 5% toxic deaths. In the present study, a combination of ESHAP plus Brentuximab Vedotin (BV) is proposed as pre-transplant therapy with the aim to improve the CR rate before ASCT.

HL is characterized by the presence of CD30-positive Hodgkin Reed-Sternberg cells. The antibody-drug conjugate BV delivers the highly potent antimicrotubule agent monomethyl auristatin E (MMAE) to CD30-positive malignant cells by binding specifically to CD30 on the cell surface and releasing MMAE inside the cell via lysosomal degradation.

Binding of MMAE to tubulin results in apoptotic death of the CD30 expressing tumor cell.

Brentuximab Vedotin in Pre-transplant Induction and Consolidation for Relapsed or Refractory Hodgkin Lymphoma

Phase I-II Clinical Trial for the Evaluation of Brentuximab Vedotin Plus Etoposide, Solumoderin (Methylprednisolone), High Dose ARA-C (Cytarabine) and Cisplatin in the Transplant and Post-transplant Management for Relapsed or Refractory Classical Hodgkin Lymphoma Patients

During phase I, defined as the maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant HL patients.

During phase II, Global response rate after BV-ESHAP as salvage regimen prior to ASCT.

Percentage of patients with complete response rate after BV-ESHAP as salvage regimen prior to ASCT.

To determine the toxicity of BV-ESHAP regimen

To assess the stem cell mobilization capacity of the BV-ESHAP regimen: determine the expanse and effectiveness of the extraction of stem cells from peripheral blood.

Percentage of patients alive after first dose of treatment through follow-up

Percentage of patients without progression of disease

Length of time between date of evidenced response and progression of disease or death

Millennium Pharmaceuticals, Inc.

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Bone Marrow Diseases

Hematologic Diseases

Alemtuzumab

All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.

Ara C (3000 mg/m2) IV every 12 hours for 6 doses (days -8 to -5)

ARA C

Cyclophosphamide (45mg/kg) IV once daily on day -7 and day -6

MESNA (45mg/kg; divided into 5 doses) will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.

MESNA

TBI: total dose 14.0 Gy, will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1

Total Body Irradiation (TBI)

CAMPATH (3 mg IV for patients between 5 and 15 kg; 5 mg for patients between 16 and 30 kg; and 10 mg for patients greater than 30 kg) will be given on day -4, day -3, day -2 and day-1.

Campath-1h

Stem Cell Infusion

Patients have a type of blood cell disorder that is very hard to cure. We are now suggesting a treatment that might help patients live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help patients as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells than we could give without the transplant. We also think that the healthy cells may help fight any diseased cells left after the transplant.

Stem Cells are special "mother" cells that are found in the bone marrow (the spongy tissue inside bones), although some are also found in the bloodstream (peripheral blood). As they grow, they become either white blood cells which fight infection, red blood cells which carry oxygen and remove waste products from the organs and tissues or platelets, which enable the blood to clot. For the transplant to take place, we will collect these stem cells from a "donor" (a person who agrees to donate these cells) and give them to recipient. Patients do not have a sibling that is a perfect match, so the stem cells will come from a donor who is the best match available. This person may be a close relative or an unrelated person whose stem cells best "matches" the patients, and who agrees to donate stem cells. Before the transplant, two very strong drugs plus total body irradiation will be given to the patient (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin producing blood cells that will eventually mature into healthy red blood cells, white blood cells and platelets.

This research study will also use CAMPATH-1H as a pre-treatment. CAMPATH-1H is an antibody against certain types of blood cells. CAMPATH-1H is important because it stays active in the body for a long time after infusion, which means it may work longer at preventing GvHD symptoms.

The stem cell transplant described above is considered to be "standard" treatment. We would like to collect additional blood as described below in order to evaluate how the immune system is recovering.

We are asking permission to draw blood from the patient so that we can measure the number of certain blood cells called T regulatory cells. T regulatory cells are special immune cells that can control or regulate the body's immune response. We want to determine whether T regulatory cells are important participants in graft versus host disease (GVHD), infection and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the body of the transplant patient (the host). GVHD can affect many different parts of the body. The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to life-threatening. We do not know whether T regulatory cells can modify these conditions. We want to measure these T regulatory cells and learn if these cells do influence these conditions. If we learn that T regulatory cells do affect these conditions, then it may be possible to modify these cells for the benefit of transplant patients.

To participate in this transplant, the patient will need to have a central line.

Before the transplant we will test the blood for viruses which can cause problems after the transplant. These viruses include Hepatitis B, cytomegalovirus and HIV. If the patient is positive for the AIDS virus, they will not be able to undertake the transplant.

Standard therapy: The patient will be given 6 doses of chemotherapy with a drug called Ara C in high doses (every 12 hours) which will begin 8 days before the stem cell transplant. Then, another chemotherapy drug called cyclophosphamide will be given in high doses by vein for two days on the 7th and 6th days before the transplant. A drug called MESNA will be given with cyclophosphamide. MESNA is used to decrease the side effects caused by cyclophosphamide. The patient will also receive an antibody called Campath (each day for 4 days before the transplant) to help destroy the immune system so that there is less host resistance to the growth of the donor cells. Radiation treatment will be given to the entire body on each day for 4 days before transplant. This will be given 2 times a day for 4 days. The chemotherapy and radiation treatment will last 8 days. If the patient has a diagnosis of T-cell Lymphoma, they will not be given the Ara-C.

Extra bone marrow tests may be recommended by the physician to check on the patients condition, especially if the marrow is slow to grow.

The day after the radiation treatment is completed; the patient will receive the healthy stem cells by vein. Once in the bloodstream, these stem cells will go to the bone marrow and should begin to grow.

In prevention of GvHD, the patient will also receive medicine called FK506 as well as low dose methotrexate. The FK506 will be given intravenously initially starting 2 days before the transplant and later by mouth (when they are able to take oral medications). This drug will be given each day for several weeks. Four doses of low dose methotrexate will be given intravenously. The methotrexate will be given on the day after the transplant, 3, 6 and 11 days after the transplant. If the GVHD cannot be controlled with FK506, other medicines may need to be given. The doctor will describe these medicines at that time.

Blood samples for research: To study how these cells are working in the patients system, blood samples will be taken each month for six months, at nine months, at one year, 2 years and 3 years following transplant. Approximately 6-8 teaspoons of blood will be collected each time. The total blood drawn for this study over three years should not exceed 1 and 3/4 cups. This amount is considered safe in adults. The amount of blood collected will be decreased in children and/or in patients where this amount of blood collection would not be appropriate.

T-Reg Cell Kinetics, Stem Cell Transplant, REGALE

T-Regulatory Cell Kinetics for Patients Receiving Alemtuzamb and Undergoing Stem Cell Transplantation From HLA Mismatched-Related, or HLA Matched, or One Antigen Mismatched-Unrelated Donors

To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol

Center for Cell and Gene Therapy, Baylor College of Medicine

A total of 24 patients were enrolled on the study and all of them received the conditioning treatment and the transplant.

Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE	NCT00578461	Leukemia Cancer Lymphoma Lymphoma, Hodgk... Lymphoma, Non-H...	Ara C Mesna Cyclophosphamid... TBI-Total Body ...	- 64 Years	Baylor College of Medicine
Brentuximab Vedotin in Pre-transplant Induction and Consolidation for Relapsed or Refractory Hodgkin Lymphoma	NCT02243436	CLASSICAL HODGK...	Brentuximab Ved... Etoposide Soludomerin Cisplatin Ara C	18 Years -	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
T-Reg Cell Kinetics, Stem Cell Transplant, REGALE	NCT00578539	Leukemia Hodgkin Lymphom... Non Hodgkin Lym... Myeloproliferat...	ARA C Cyclophosphamid... MESNA Total Body Irra... Campath-1h Stem Cell Infus...	-	Baylor College of Medicine
Brentuximab Vedotin in Pre-transplant Induction and Consolidation for Relapsed or Refractory Hodgkin Lymphoma	NCT02243436	CLASSICAL HODGK...	Brentuximab Ved... Etoposide Soludomerin Cisplatin Ara C	18 Years -	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
T-Reg Cell Kinetics, Stem Cell Transplant, REGALE	NCT00578539	Leukemia Hodgkin Lymphom... Non Hodgkin Lym... Myeloproliferat...	ARA C Cyclophosphamid... MESNA Total Body Irra... Campath-1h Stem Cell Infus...	-	Baylor College of Medicine
T-Reg Cell Kinetics, Stem Cell Transplant, REGALE	NCT00578539	Leukemia Hodgkin Lymphom... Non Hodgkin Lym... Myeloproliferat...	ARA C Cyclophosphamid... MESNA Total Body Irra... Campath-1h Stem Cell Infus...	-	Baylor College of Medicine
T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE	NCT00578461	Leukemia Cancer Lymphoma Lymphoma, Hodgk... Lymphoma, Non-H...	Ara C Mesna Cyclophosphamid... TBI-Total Body ...	- 64 Years	Baylor College of Medicine

Spots Global Cancer Trial Database for ara c

Every month we try and update this database with for ara c cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for ara c

Every month we try and update this database with for ara c 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 ara c 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.