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Cord Blood Transplantation for Patients With Cancer

This study has been terminated.
(did not accrue enough patients.)
Sponsor:
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT01359254
First received: May 20, 2011
Last updated: July 8, 2012
Last verified: July 2012
History of Changes
  Purpose

To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.


Condition Intervention
Hematological Disease
 Drug: Melphalan, Fludarabine, and Antithymocyte Globulin (ATG)
Drug: Fludarabine, Busulfan, ATG, and Total Body Irradiation (TBI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Cord Blood Engraftment [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.


Secondary Outcome Measures:
  • Survival at Day 100 [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    Being alive 100 days after the stem cell infusion


Enrollment: 1
Study Start Date: April 2010
Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
 Drug: Melphalan, Fludarabine, and Antithymocyte Globulin (ATG)
Fludarabine is given daily for 5 days. Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. ATG is given every other day for 4 days.
Experimental: Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
 Drug: Fludarabine, Busulfan, ATG, and Total Body Irradiation (TBI)
Fludarabine is given through the vein daily for 5 days; Busulfan is given daily for 4 days; and ATG every other day for 4 days. TBI is given twice on the last day.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359254

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Andrew Artz, MD University of Chicago
  More Information

No publications provided

Responsible Party: Andrew Artz, MD, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01359254     History of Changes
Other Study ID Numbers: 10-020-B
Study First Received: May 20, 2011
Last Updated: July 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Diseases
Antilymphocyte Serum
Busulfan
Melphalan
Fludarabine monophosphate
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013