Know Cancer

or
forgot password

An Expanded Access Study of the Feasibility of Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients


N/A
N/A
21 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Lymphomas, Bone Marrow Failure, Hemoglobinopathy, Immune Deficiency, Osteopetrosis, Cytopenias, White Blood Cell Abnormalities, Red Blood Cell Abnormalities

Thank you

Trial Information

An Expanded Access Study of the Feasibility of Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients


Inclusion Criteria:



- Age 0 (newborn) - 21 years

- Patient must have a malignant or non-malignant disease that can benefit from
alternative stem cell transplantation according to standard practice guidelines.

- Patients with lymphoma or acute leukemia (except acute myeloid leukemia, AML) must be
in remission at the time of transplant.

- Patients must lack a healthy human leukocyte antigen (HLA)-identical related donor.

- Recipient or authorized guardian must sign informed consent for this study.

- If recipient is female and of child-bearing age, negative pregnancy test.

- Patient must have a healthy, willing mismatched related or an unrelated donor who is:

- Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo
apheresis either through placement of catheters in antecubital veins or a
temporary central venous catheter,

- For Related donor: sibling, half-sibling, parent, cousin, aunt, uncle or
grandparent will all be considered eligible.

- For Related donor: HLA antigen genotypic match ≥ 4/8 and ≤ 7/8
(haplocompatible).

- For unrelated donor: 6/8 or 7/8 HLA antigen match (if two mismatches, they must
be at different loci).

- Complete medical history, physical and screening for infectious diseases that
are acceptable for donation.

- If donor is female and of child-bearing age, negative pregnancy test.

- Absence of anti-HLA antibodies in recipient directed against donor antigens.

- Donor must be willing to sign informed consent for this study. If donor is < 18
years of age, donor must be willing to give assent and parents willing to sign
informed consent. For unrelated donors: The National Marrow Donor Program (NMDP)
will obtain informed consent for donor's apheresis product to be used in this
study.

- Age ≥ 11 years

Exclusion Criteria:

- Patient with an anticipated life expectancy of < 1 month

- Active infectious hepatitis or cytomegalovirus (CMV) disease (organ involvement)

- Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV-I/II)
infection

- Cardiac ejection fraction < 45%; can be lower if patient is not in clinical cardiac
failure and a reduced intensity conditioning regimen is used.

- Creatinine clearance <60 ml/min/1.72 m2; can be lower if a reduced intensity
conditioning regimen is used.

- Pulmonary diffusion capacity (corrected for hemoglobin), forced expiratory volume in
one second (FEV1), or forced vital capacity (FVC) <60% of predicted or oxygen
saturation (O2 sat) > 94% on room air if unable to perform pulmonary function tests
(PFTs); can be lower if a reduced intensity conditioning regimen is used.

- Serum alanine aminotransferase (ALT) > 5 x upper limit of normal (can be up to 10x
upper limit of normal if a reduced intensity conditioning regimen is used) or
bilirubin > 2.

- Performance score (Lansky/Karnofsky) < 50

- Any condition that compromises compliance with the procedures of this protocol, as
judged by the principal investigator.

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Morton J. Cowan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSF Children's Hospital

Authority:

United States: Food and Drug Administration

Study ID:

UCSF-10082

NCT ID:

NCT01200017

Start Date:

September 2010

Completion Date:

September 2020

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Lymphomas
  • Bone Marrow Failure
  • Hemoglobinopathy
  • Immune Deficiency
  • Osteopetrosis
  • Cytopenias
  • White Blood Cell Abnormalities
  • Red Blood Cell Abnormalities
  • T cell depleted
  • Matched unrelated donors
  • Haplocompatible donors
  • Graft vs Host Disease
  • Hemoglobinopathies
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Osteopetrosis
  • Pancytopenia
  • Immune System Diseases
  • Hematologic Diseases
  • Genetic Diseases, Inborn
  • Neoplasms by Histologic Type
  • Neoplasms
  • Lymphoproliferative Disorders
  • Lymphatic Diseases
  • Immunoproliferative Disorders
  • Myeloproliferative Disorders
  • Bone Marrow Diseases
  • Precancerous Conditions
  • Osteosclerosis
  • Osteochondrodysplasias
  • Bone Diseases, Developmental
  • Bone Diseases
  • Musculoskeletal Diseases
  • Severe acquired and congenital cytopenias
  • White and red blood cell abnormalities
  • Congenital Abnormalities
  • Graft vs Host Disease
  • Hemoglobinopathies
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Osteopetrosis
  • Pancytopenia
  • Leukocyte Disorders

Name

Location

University of California, San Francisco (UCSF) Children's HospitalSan Francisco, California  94143