Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Lymphoma

Leukemia

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Lymphosarcoma

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Melphalan

Thiotepa

Antilymphocyte Serum

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

total-body irradiation (TBI)

thiotepa

fludarabine phosphate

melphalan

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis

Richard O'Reilly, MD

Approximately 30% of patients who are candidates for bone marrow transplants do not have an HLA-matched, or close to matched, donor available. For this reason, doctors have been testing ways to make transplants from HLA-partially matched donors as safe and effective as transplants from HLA-matched donors.

This study is being done to test the safety and the treatment results of a specific kind of transplant. In this transplant, blood from two donors will be used. Each donor will share one half of your HLA type. Blood from both donors will be transplanted at the same time.

Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor

Efficacy is measured by:

1. incidence of transplant-related mortality, overall survival and disease-free survival at 1 year post transplant.
2. incidence, tempo and complications of engraftment and hematopoietic reconstitutions and conversely, the risk of graft failure
3. incidence and severity of acute and/or chronic GVHD
4. incidence and severity of opportunistic infections developing following engraftment

The levels of engraftment and persistence of hematopoietic cells and their myeloid and lymphoid progressing from each donor post transplant. The tolerance or reactivity of engrafted T cells from each donor detected in the blood at 3, 6, and thereafter every 3-6 months until normal, post transplant against host cells and cells derived from the other parent as measured by standard mixed lymphocyte culture and cell mediated cytolysis assays.

Memorial Sloan Kettering Cancer Center

Regimen 2

REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

total-body irradiation (TBI)

thiotepa

fludarabine phosphate

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis

REGIMEN 1

To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

thiotepa

fludarabine phosphate

melphalan

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Zero participants were enrolled to Regimen 1

Dr. Richard O'Reilly, MD

Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.

Efficacy of HLA-haploidentical Biparental T-cell Depleted CD34+ Peripheral Blood Stem Cell Transplants

Evaluation of Recipients Post Transplant

Overall Study

Leukemia, Myeloid

Hematologic Neoplasms

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hodgkin Disease

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloproliferative Disorders

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Myeloid Leukemia

Hodgkin Lymphoma

Chronic Myeloproliferative Disorders

Antirheumatic Agents

Anti-Infective Agents

Dermatologic Agents

Cyclophosphamide

Cyclosporine

Cyclosporins

Mycophenolic Acid

There are three chemotherapy drugs involved. They are called fludarabine (5 doses), cyclophosphamide (1 dose), and thiotepa (2 doses). Also two days of radiation therapy. This is called Total Body Irradiation or TBI. The TBI if given for two days before, the transplant. On transplant day, the cord blood cells will be given through a catheter. The immune suppressing drugs given are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through the catheter. Later they can be given as tablets.

Cyclophosphamide 50 mg/kg/dose x 1 IV day -6 (1 dose) Fludarabine 30 mg/m2/dose x 5 IV days -6 to -2 (5 doses) Thiotepa 5 mg/kg/dose x 2 IV days -5 to -4 (2 doses) TBI 200 cGy/dose x 2 days -2 to -1 (2 doses). On transplant day, the cord blood cells will be given through your catheter. The immune suppressing drugs you will receive are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through your catheter. Later they can be given as tablets.

fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft

Juliet Barker, MBBS

The traditional way of doing a donor transplant is to give high doses of chemotherapy and radiation before giving the stem cells. However, high doses of chemotherapy and radiation can have serious side-effects. The doctors think that the transplant will be safer and more likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this study is to find out how good a combination of chemotherapy and radiation at reduced doses followed by a cord blood transplant are at treating cancer.

The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood is collected from healthy newborn babies and frozen. One cord blood collection is called a "cord blood unit." On transplant day, the cord blood will be given through the catheter just like a blood transfusion. Transplants done this way have been successful. However, this type of transplant is fairly new. Therefore, it is important to study it so the doctors can better understand how it works.

Most blood or bone marrow transplants using donor stem cells are done as part of a study. When patients are on a study we test new ways of treating them which we think may be better than the old ways. We collect information about the result of this treatment so we can understand how well the treatment works. This is so we can learn better ways to treat our patients.

Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

A Reduced Intensity Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

To obtain a preliminary estimate of progression free survival at 1 year post UCBT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Successful primary donor engraftment = neutrophill recovery within the first 45 days after transplant and partial/complete donor chimerism (\>/= 10%)

The day 100 cumulative incidence of sustained CB-derived neutrophil engraftment.

The day 100 cumulative incidence of sustained CB-derived platelet engraftment to \>/= 20 x 10\^9/L

Participants With Hematologic Malignancies

Progression Free Survival/PFS at 1 Year Post UCBT.

Haplo-dCBT with early haplo-derived myeloid bridge

Haplo-dCBT with transient haplo-derived bridge with second neutrophil nadir

Haplo-dCBT with no bridge

Remaining dCBT recipient

43 haplo-dCBT recipients in this analysis 43 dCBT recipient

Number of Participants With Neutrophil Recovery Post Allograft for Haplo-dCBT Recipients

Percentage of Participants With Sustained CB-derived Neutrophil Engraftment

Percentage of Participants With Sustained CB-derived Platelet Engraftment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor	NCT01598025	Acute Leukemia Chronic Leukemi... Myelodysplastic... Non-Hodgkins Ly...	total-body irra... thiotepa fludarabine pho... melphalan anti-thymocyte ... allogeneic hema... peripheral bloo... laboratory biom...	- 19 Years	Memorial Sloan Kettering Cancer Center
Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.	NCT00739141	Leukemia Myelodysplastic... Non-Hodgkins Ly... Chronic Myeloge... Hodgkins Lympho...	fludarabine, cy...	18 Years - 70 Years	Memorial Sloan Kettering Cancer Center
Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor	NCT01598025	Acute Leukemia Chronic Leukemi... Myelodysplastic... Non-Hodgkins Ly...	total-body irra... thiotepa fludarabine pho... melphalan anti-thymocyte ... allogeneic hema... peripheral bloo... laboratory biom...	- 19 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for thi0tepa

Every month we try and update this database with for thi0tepa 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 thi0tepa

Every month we try and update this database with for thi0tepa 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 thi0tepa 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.