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Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Hematologic Malignancies

Thank you

Trial Information

Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies


Inclusion Criteria:



Subjects 18-70 years old. ECOG 0-2

Patients must have a diagnosis of one of the following:

- Chronic Myeloid Leukemia

- Acute Myeloid Leukemia

- Acute Lymphoblastic Leukemia

- Hodgkin's Disease

- Non-Hodgkins Lymphoma

- Myelodysplastic Syndromes

- Myeloproliferative Disorder

Patients must have adequate visceral organ function

- Patients must furnish written informed consent and HIPAA authorization for release of
personal health information.

- Patients must be able to understand the requirements of the study, abide by the study
restrictions, and agree to return for the required assessments.

Exclusion Criteria:

- Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good
health who is willing to donate stem cells are ineligible.

- Patients who are pregnant are ineligible.

- Patients are ineligible if they have received cumulative chemotherapy doses in excess
of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess
of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan
shows greater than/equal to 45% ejection fraction.

Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event Free Survival

Outcome Description:

Number of subjects surviving with no events at 180 days post transplantation (Day 0).

Outcome Time Frame:

180 days

Safety Issue:

Yes

Principal Investigator

Mary J. Laughlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

15954 UCB-2011

NCT ID:

NCT01622556

Start Date:

January 2012

Completion Date:

January 2017

Related Keywords:

  • Hematologic Malignancies
  • Chronic Myeloid Leukemia
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkins Lymphoma
  • Hodgkin's Disease
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorder
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

University of Virginia Charlottesville, Virginia  22908