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Unrelated Umbilical Cord Blood (UCB) Transplantation


Phase 2
16 Years
70 Years
Open (Enrolling)
Both
Chronic Myelogenous Leukemia (CML), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome, Multiple Myeloma, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia (CLL), Acute Lymphocytic Leukemia (ALL), Severe Aplastic Anemia

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Trial Information

Unrelated Umbilical Cord Blood (UCB) Transplantation


Allogeneic hematopoietic cell transplantation (allo- HCT) is a curative therapy for the
treatment of hematological and non-hematological malignancies and certain non-malignant
conditions. Bone marrow or peripheral blood from a Human Leukocyte Antigen (HLA) matched
sibling donor is the most commonly used source of allogeneic stem cells. However, HLA
matched siblings are available for less than one third of the patients who require allo-
SCT. In the absence of an HLA matched sibling, volunteer unrelated donors or partially
mismatched related donors (PMRD), stored cord blood may be used as a source of allogeneic
stem cells. Stored cord blood has been used as a source of allogeneic stem cells in infants
and children, but had early skepticism in adults because of concerns about the engraftment
potential of the relatively limited number of stem cells. The number of stem cells in a unit
of cord blood is generally one log less than the number of stem cells on an average
collection of bone marrow from an adult for transplantation.

After the success of the first allogeneic umbilical cord blood transplantation in 1988,
programs for banking screened unrelated donor CBSC have been initiated both in the United
States and Europe. Dr Pablo Rubenstein started the first such bank at the New York Blood
Center (NYBC) in 1993. Since its inception, the NYBC has provided unrelated donor cord blood
stem cells for over 1000 transplants. Analysis of outcomes for the initial 562 transplant
recipients from the NYBC revealed a cumulative rate of engraftment of 81% by day 42 for
PMNs. and 85% by day 180 for platelets. Currently, approximately more than 100,000 cord
blood units are available in cord blood banks worldwide and more than 2000 patients have
received cord blood transplants from these banks. NetCord, an international cooperative
group of cord blood banks, has developed a detailed set of standards for cord blood banking
to facilitate international exchanges and to guarantee the quality of these products.

Cord Blood Unit Selection:

UCB units will be required to be a 4 to 6 of 6 HLA-A, -B antigen and -DRB1 allele match with
the patient. Typing at HLA-C and -DQ will be obtained but not required in the match
strategy. A minimum total nucleated cell (TNC) dose of >2.0 x 107/kg at the time of
freezing will be utilized when possible. When using double units, each unit should contain
a minimum pre-cryopreserved TNC dose of 1.5 x 107/kg.

UCB Transplant Procedure:

There will be a myeloablative and reduced-intensity preparative regimen that can be given
prior to infusion of cord product. The myeloablative approach will be selected in younger
patients (<50yo) with a HCT-CI score <3. The reduced-intensity regimen will be selected for
all older patients (>50) or younger patients with a HCT-CI score >3. The reduced-intensity
regimen will also be chosen for any patients being transplanted for indolent/follicular
lymphomas, CLL, myeloma, or Hodgkin lymphoma; irrelevant of age or HCT-CI score. On a case
by case basis, patients may receive a preparative regimen outside of their designated
category as noted above with the approval of the PI, if deemed in the patient's best
interest.


Inclusion Criteria:



- Age: 16-70 years

- Available 4/6, 5/6, or 6/6 HLA antigen match (using A, B, and DRB1) cord blood unit.

- ECOG performance status of 0-2 (Karnofsky greater than or equal to 70%)

- Serum bilirubin less than 2 x upper limit of normal

- Serum creatinine less than 2 mg/dl

- DLCO or FEV1 greater than or equal to 50% predicted

- Left ventricular ejection fraction greater than or equal to 35%

- no uncontrolled infection

- If female, not pregnant

- Informed consent given

- No major organ dysfunction precluding transplantation.

- One of the following malignancies or bone marrow failure syndromes:

- Chronic myelogenous leukemia (CML)

- Acute myelogenous leukemia (AML)

- Myelodysplastic syndrome

- Multiple myeloma

- Hodgkin lymphoma

- Non-Hodgkin lymphoma

- Chronic lymphocytic leukemia (CLL)

- Acute lymphocytic leukemia (ALL)

- Severe Aplastic Anemia

Exclusion Criteria:

- Patient pregnant

- Age less than 16, greater than 70

- ECOG performance status of greater than 2 (Karnofsky less than 70%)

- Psychiatric disorder or mental deficiency of the patient sufficiently severe as to
make compliance with the BMT treatment unlikely, or making informed consent
impossible

- Serum bilirubin greater than or equal to 2 x upper limit of normal, transaminases
greater than 3 x upper limit of normal

- Serum creatinine greater than or equal to 2 mg/dl

- DLCO less than 50% predicted

- Left ventricular ejection fraction less than 35%

- Major anticipated illness or organ failure incompatible with survival from BMT

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Engraftment

Outcome Description:

Defined as neutrophil recovery associated with donor engraftment within the first 60 days of transplant

Outcome Time Frame:

60 days

Safety Issue:

No

Principal Investigator

Michael Craig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University

Authority:

United States: Food and Drug Administration

Study ID:

WVU 1909

NCT ID:

NCT01768845

Start Date:

February 2009

Completion Date:

December 2017

Related Keywords:

  • Chronic Myelogenous Leukemia (CML)
  • Acute Myelogenous Leukemia (AML)
  • Myelodysplastic Syndrome
  • Multiple Myeloma
  • Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)
  • Acute Lymphocytic Leukemia (ALL)
  • Severe Aplastic Anemia
  • Chronic myelogenous leukemia (CML)
  • Acute myelogenous leukemia (AML)
  • Myelodysplastic syndrome
  • Multiple myeloma
  • Hodgkin lymphoma
  • Non Hodgkin lymphoma
  • Chronic lymphocytic leukemia (CLL)
  • Acute lymphocytic leukemia (ALL)
  • Severe Aplastic Anemia
  • Cord Blood
  • Umbilical cord blood transplantation
  • UBC transplantation
  • Anemia
  • Anemia, Aplastic
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

West Virginia University Hospitals Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506