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Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

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Adjuvants, Immunologic

Antineoplastic Agents, Immunological

3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.

Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)

Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.

3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.

Campath-1H

10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.

G-CSF

250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.

GM-CSF

BCNU

Stem Cell Transplant

Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.

Preparative Regimen for Allogenic Stem Cell Transplantation

200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),

200 mg/m2 IV twice on day -5 to -2 (total 8 doses)

15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation

Campath

750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).

Low dose total body irradiation of 2 Gy day 0.

Low dose total body irradiation

Issa F. Khouri, MD

Primary Objectives:

1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
4. To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.

Campath is a drug that can specifically attack some types of T-cell lymphoma cells.

Before the study begins, you will have a physical exam, including blood (about 2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Patients will have a chest x-ray, an EKG (test to measure the electrical activity of the heart), and tests of lung function. Patients whose disease affects the stomach or intestines may have biopsies of these areas.

Treatment will be given in the hospital at M. D. Anderson. You will need to stay in the hospital for about 3 to 4 weeks.

A central venous catheter (plastic tube) will be placed into the large chest vein. The catheter will be left in place throughout treatment. In order to collect stem cells, G-CSF and GM-CSF will be injected under the skin. This will be done twice a day until the collection of stem cells is complete. You will receive Campath -1H through the catheter on Days 1, 2, 3, and 10 of chemotherapy treatment.

The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is given. The collection process is called apheresis. Blood is removed from the your body and the stem cells are frozen for storage. Stem cell collection takes about 3 hours. Between 3 and 5 sessions may be needed to collect enough stem cells. Sessions will be done once a day.

After stem cells are collected, you will receive high dose Carmustine over 1 hour on Day 1. You will receive cytarabine and etoposide twice a day on Days 2 through 5 and melphalan on Day 6.

One day after finishing the chemotherapy, the stem cells that were collected earlier will be infused back into you over about 30 minutes. G-CSF and GM-CSF will be injected until your white blood cell counts returns to normal.

Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. You will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital.

You might have to stay in the Houston area for 2 to 4 weeks after the transplant. After that, you will need to return to Houston every 3 months for the first year, then every 6 months for 5 years. Three months after the transplant, bone marrow exams and other tests will be done. If you show evidence of disease, you will receive another cycle of Campath -1H three times a week for 4-12 weeks. Patients will be taken off study if the disease gets worse or intolerable side effects occur.

This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma:

Campath is a drug that can specifically attack some types of T-cell lymphoma cells. In addition, it weakens the immune system, therefore helping to prevent the rejection of donor marrow or stem cells.

TBI is designed to damage the DNA (the genetic material of cells) of cancer cells, which may kill the cancer cells.

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.

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

Before the study begins, you will have a physical exam, including blood (about 1-2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have a chest x-ray, CT scans, an EKG (test to measure the electrical activity of the heart), and tests of lung function.

Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. Patients will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital.

Campath-1 H will be injected into your vein. This will be done 3 days in a row (Days 1 to 3). The drugs diphenhydramine (Benadryl), acetaminophen (Tylenol) and hydrocortisone will be given in to decrease the risk of or ease side effects.

You will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given starting day of Campath -1H.

All of the chemotherapy drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment. After completion of chemotherapy, you will receive TBI, and later on the same day, blood stem cells from a donor will be given through the catheter. G-CSF and GM-CSF, growth factors that promote the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood.

Tacrolimus will be infused through the vein, starting 2 days before transplant to decrease the risk of graft-versus-host disease. It will be changed to pills after you are discharged from the hospital. For the same purpose, methotrexate will also be given through the vein on Days 1, 3, 6 (and Day 11 if unrelated donor).

Treatment will be given in the hospital at UTMDACC. You will need to stay in the hospital for about 3 to 4 weeks.

You must stay in the Houston area for about 100 days after the transplant. After that, you will need to return to Houston every three months for the first year, then every 6 months for 5 years for blood tests (1-2 tablespoons), urine tests, and CT scans. Bone marrow aspirations and biopsies will also be performed. Patients will be taken off study if the intolerable side effects occur.

This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at UTMDACC.

Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52

Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.

Bayer

M.D. Anderson Cancer Center

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Issa F. Khouri, MD / Associate Professor

Analysis was per protocol. Nine participants were not eligible for treatment therefore were excluded from analysis.

Participant Progression Free Survival at 2 Years

Overall Study

Leukemia

Leukemia, Promyelocytic, Acute

Hematologic Diseases

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute Graft Versus Host Disease

Acute Promyelocytic Leukemia

Arsenic Trioxide

Induction ATO 0.15 mg/kg/day IV until CR or a maximum of 60 days In isolated molecular relapse ATO will be administered at same dose, 5 days a week, during 6 weeks.

Consolidation ATO 0.15 mg/kg/day IV 5 days week, during 5 weeks

Autologous Transplantation

Allogenic Transplantation

Consolidation: ATRA 45 mg/m²/day oral during 5 weeks

ATRA

Sanz Miguel Angel, Dr

Esteve Jordi, Dr

Montesinos Pau, Dr

Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia.

By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be reached. On average, about 10% of patients still die in the early phase of the treatment and about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the individual kinetics of MRD and to identify patients with an imminent hematological relapse.

A standardized treatment for patients with relapsed APL has not yet been established. With arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower concentrations. ATO was also successfully administered before allogeneic and autologous transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe and in the USA.

After remission induction, there are several options for postremission therapy Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg

Induction ATO 0.15 mg/kg/día IV in continuous perfusion 1-2 hours/day until complete response (CR) or maximum of 60 days.

Oral hydroxyurea treatment (initial dose 2 g/day)is recommended in patients with leucocyte counts at relapse \>10x109/L or in the two first weeks of induction.

Isolated molecular relapsed patients will be treated with ATO (same dose) 5 days at week, during 6 weeks.

Consolidation ATO 0.15 mg/kg/día IV 5 days at week, during 5 weeks, combined with oral ATRA 45 mg/m²/day during the same 5 weeks.

Post-consolidation therapy TPH (autologous or allogenic) in candidate patients. In case of molecular remission, is recommended autologous-TPH.

Patients no candidates to auto-TPH or alo-TPH, should will follow treatment with ATO cycles + ATRA +/- Mylotarg.

1. Option Alo-TPH If PCR post-consolidation is negative is recommended auto-TPH. However, if alo-TPH is decided, it will be done immediately without preceding chemotherapy.

   If PCR post-consolidation is positive, should done alo-TPH.
2. Option Auto-TPH If PCR post-consolidation is negative it will be administered one cycle of MTZ + Ara-C follow by auto-TPH.

   In cas of failure: a) if patient has autologous stem cells preserved (PCR negative) are suitable for auto-TPH; b) patients with HLA-compatible donor who are suitable for allogenic stem cell transplantation should be transplanted; c) Patients who are not eligible for allogenic or autologous transplantation, receive various cycles with ATO + ATRA combined or not with Mylotarg.

   If PCR post-consolidation is positive and patient is eligible for allogenic TPH, should be done a allogenic TPH.

   If patient is no eligible for allogenic TPH or dont has compatible donor, will be administrate one cycle of MTZ + Ara-C and collect stem cells. Autologous transplantation will be done if after this cycle, a molecular remission is obtained. No molecular remission or no enough stem cells collection, patient follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg.
3. ATO + ATRA combined or no with Mylotarg Patients no eligible to autologous TPH or allogenic TPH follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg.

If Mylotarg is no possible, treatment will be with subsequent cycles of ATO + ATRA.

ATO + ATRA + Mylotarg: Mylotarg 6 mg/m2 day 1, ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15. Doses of mylotarg should be reduced to 3 mg/m2 in patients aged over 60 years. Administration of 3 cycles with a month interval, follow of 3 to 6 cycles of ATO + ATRA without Mylotarg. After, ATRA 45 mg/m2/d 15 days every 3 months until complete two years of maintenance.

ATO + ATRA: ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15, every 29 days. Administration of 9 cycles, and followed by ATRA 45 mg/m2/d during 15 days every 3 months until complete two years of maintenance.

Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

PETHEMA Foundation

Symptoms and General Pathology

Behaviors and Mental Disorders

Syndrome

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Suicide

Graft vs Host Disease

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Homologous Wasting Disease

2x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant.

Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.

5x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant.

Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.

1x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant.

Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.

3x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant .

Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.

Subjects will receive 2x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

BPX-501 dose 1

Dimerizer drug administered by intravenous infusion in those subjects who develop GVHD after infusion of BPX-501 cells.

Rimiducid

Subjects will receive 5x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

BPX-501 dose 2

Subjects will receive 1x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

BPX-501 dose 3

Subjects will receive 3x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

BPX-501 dose 4

all subjects will receive an alpha beta depleted donor transplant as part of treatment

Bellicum Pharmaceuticals

This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.

This is a Phase1/2 dose escalation study evaluating the safety and feasibility of BPX-501 infused after partially mismatched, related (haploidentical), T cell-depleted HSCT. The purpose of this clinical trial is to determine whether BPX-501 infusion can facilitate engraftment, enhance immune reconstitution and potentially improve the graft versus leukemia (GVL) effect, with the potential for reducing the severity and duration of severe acute graft versus host disease (GvHD). The trial will evaluate the treatment of GvHD by the infusion of dimerizer drug (Rimiducid) in those subjects who present with GvHD that does not adequately respond to standard of care therapy.

Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant

A Phase 1/2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells After Partially Mismatched, Related, T Cell-Depleted HSCT (Hematopoietic Stem Cell Transplant)

To evaluate the safety of infusion of each of 4 dose cohorts of BPX-501 (2x105, 5x105, 1x106 and 3x106 cells/kg) after transplantation of partially mismatched T cell depleted hematopoietic stem cell transplant (HSCT)

To evaluate the safety of the infusion of the rimiducid in subjects who received BPX-501 and have developed visceral or steroid refractory graft-versus-host-disease

To determine the maximum dose of BPX-501 (up to 3x106 cells/kg) that results in an adjusted cumulative incidence by Day 100 of no more than 45% Grade II - IV aGVHD and / or no more than 17% Grade III -IV aGVHD.

To assess immune reconstitution for each dose cohort

Evaluation of neutrophil and platelet engraftment, kinetics of donor cell engraftment and graft failure

Incidence and severity of acute and chronic GvHD

Time to resolution of acute GvHD after administration of Rimiducid

Characterize the safety profile of BPX-501 including evaluation of high grade toxicity and infectious complications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma	NCT00505921	Lymphoma	Campath-1H G-CSF GM-CSF BCNU Stem Cell Trans... Preparative Reg... Cytarabine Etoposide Melphalan Campath Fludarabine Cyclophosphamid... Low dose total ...	- 70 Years	M.D. Anderson Cancer Center
Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)	NCT00504764	Acute Promyeloc...	Arsenic Trioxid... Autologous Tran... Allogenic Trans... ATRA	18 Years -	PETHEMA Foundation
Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant	NCT01744223	Acute Lymphobla... Acute Myelogeno... Lymphoma Myelodysplastic...	BPX-501 dose 1 Rimiducid BPX-501 dose 2 BPX-501 dose 3 BPX-501 dose 4 SCT	18 Years - 65 Years	Bellicum Pharmaceuticals

Spots Global Cancer Trial Database for allogenic transplantation