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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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 antithymocyte globulin:atg