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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

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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 (AdriamycinĀ®) 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