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Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies


N/A
18 Years
N/A
Not Enrolling
Both
Hematological Disease

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Trial Information

Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies


Inclusion Criteria:



- Relapsed or refractory acute leukemia (myeloid or lymphoid)

- Acute leukemia in first remission at high-risk for recurrence

- Chronic myelogenous leukemia in accelerated phase or blast-crisis

- Chronic myelogenous leukemia in chronic phase

- Recurrent or refractory malignant lymphoma or Hodgkin lymphoma

- Chronic lymphocytic leukemia, relapsed or with poor prognostic features

- Multiple myeloma

- Myelodysplastic syndrome

- Chronic myeloproliferative disease

- Hemoglobinopathies

- Aplastic anemia

Exclusion Criteria:

- Zubrod performance status > 2

- Life expectancy is severely limited by concomitant illness

- Patients with severely decreased LVEF or impaired pulmonary function tests

- Estimated Creatinine Clearance <50 ml/min

- Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal

- Evidence of chronic active hepatitis or cirrhosis

- HIV-positive

- Patient is pregnant

- Patient or guardian not able to sign informed consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cord Blood Engraftment

Outcome Description:

Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.

Outcome Time Frame:

100 days

Safety Issue:

No

Principal Investigator

Andrew Artz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

10-020-B

NCT ID:

NCT01359254

Start Date:

April 2010

Completion Date:

June 2012

Related Keywords:

  • Hematological Disease
  • Hematologic Diseases

Name

Location

University of ChicagoChicago, Illinois  60637