Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Preleukemia

Myelodysplastic Syndromes

Anemia, Refractory, with Excess of Blasts

Leukemia, Biphenotypic, Acute

Lymphoma

Anemia

Anemia, Refractory

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloproliferative Disorders

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Acute Leukemia of Ambiguous Lineage

Myelodysplastic Syndrome With Excess Blasts

Lymphosarcoma

Chronic Myeloproliferative Disorders

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Thiotepa

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive either regimen A or regimen B.

REGIMEN A: Patients (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo TBI BID on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.

REGIMEN B: Patients (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients undergo TBI QD on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.

All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo MUGA or ECHO, and CT during screening. Patients also undergo blood sample collection on study.

Dilanubicel

Total-Body Irradiation

Umbilical Cord Blood Transplantation

Laboratory Biomarker Analysis

Biospecimen Collection

Bone Marrow Aspirate

Bone Marrow Biopsy

Multigated Acquisition Scan

Electrocardiography

Computed Tomography

Filippo Milano

This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

OUTLINE:

Patients receive either regimen A or regimen B.

REGIMEN A: Patients (10 through 45 years old) receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.

REGIMEN B: Patients (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients undergo TBI once daily (QD) on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.

All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo multigated acquisition scan (MUGA) or echocardiography (ECHO), and computed tomography (CT) during screening. Patients also undergo blood sample collection on study.

After completion of study treatment, patients are followed up at 180 days, 1 year, and 2 years.

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes

Pilot Study: Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies

Primary graft failure/rejection as defined by no neutrophil recovery (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow \[BM\]).

The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500 after the 1st post-cord blood transplant nadir.

Measured by the number of participants with a platelet count \> 20,000/ul without subsequent transfusions for 7 days

Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.

Assessed using the Acute GVHD Grading Scale (reference: Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant 1995; 15: 825-8).

Assessed using the Chronic GVHD Grading Scale (reference: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease. I. Diagnosis and Staging Working Group report. Blood Marrow Transplant 2005; 11: 945-56).

Nohla Therapeutics, Inc.

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

Fred Hutchinson Cancer Center

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Leukemia, Myeloid, Acute

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Erythroid Leukemia

Di Guglielmo's Syndrome

Acute Megakaryoblastic Leukemia

Anti-Infective Agents

Vidarabine

Antimetabolites

Antiviral Agents

Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

Timothy Henrich

Blachy Saldana

Kirsten Boughan

Marcie Finney

Mary Laughlin

This phase II trial studies the side effects of a cord blood transplant using dilanubicel and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. Dilanubicel consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with dilanubicel may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.

OUTLINE: Patients are assigned to 1 of 2 regimens.

REGIMEN A: Patients receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

REGIMEN B: Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI once daily (QD) on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28, 80, and 180 days, and then at 1 and 2 years.

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers

Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies

Will be defined by no neutrophil recovery by day 45 (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow) by day 45.

Defined as Common Terminology Criteria for Adverse Events version 5.0 grade \>= 3 events.

Will be defined as the first day of 2 consecutive days of absolute neutrophil count \>= 500 after the first post-cord blood transplant nadir.

Will be defined as the first day of a platelet count \> 20,000/ul with subsequent transfusions for 7 days.

Will be defined by the 2014 National Institutes of Health (NIH) criteria.

Will be defined by the 2014 NIH criteria.

Will be defined as death without a prior relapse.

Concentration of immunity cells per microliters after transplant

HIV viral load by PCR (copies per milliliter; mL)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes	NCT03399773	Acute Biphenoty... Acute Lymphobla... Chronic Myeloge... Hematopoietic a... Myelodysplastic... Myelodysplastic...	Dilanubicel Cyclophosphamid... Fludarabine Thiotepa Total-Body Irra... Umbilical Cord ... Laboratory Biom... Biospecimen Col... Bone Marrow Asp... Bone Marrow Bio... Multigated Acqu... Electrocardiogr... Computed Tomogr...	10 Years - 65 Years	Fred Hutchinson Cancer Center
Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers	NCT04083170	Acute Erythroid... Acute Lymphobla... Acute Megakaryo... Acute Myeloid L... Chronic Myeloge... Hematopoietic a... HIV Infection Myelodysplastic... Myelodysplastic... Non-Hodgkin Lym... Refractory Anem...	Fludarabine Cyclophosphamid... Thiotepa Total-Body Irra... Umbilical Cord ... Dilanubicel	6 Months - 65 Years	Fred Hutchinson Cancer Center
Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers	NCT04083170	Acute Erythroid... Acute Lymphobla... Acute Megakaryo... Acute Myeloid L... Chronic Myeloge... Hematopoietic a... HIV Infection Myelodysplastic... Myelodysplastic... Non-Hodgkin Lym... Refractory Anem...	Fludarabine Cyclophosphamid... Thiotepa Total-Body Irra... Umbilical Cord ... Dilanubicel	6 Months - 65 Years	Fred Hutchinson Cancer Center
Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers	NCT04083170	Acute Erythroid... Acute Lymphobla... Acute Megakaryo... Acute Myeloid L... Chronic Myeloge... Hematopoietic a... HIV Infection Myelodysplastic... Myelodysplastic... Non-Hodgkin Lym... Refractory Anem...	Fludarabine Cyclophosphamid... Thiotepa Total-Body Irra... Umbilical Cord ... Dilanubicel	6 Months - 65 Years	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for dilanubicel

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

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