ClinicalTrials.gov
ClinicalTrials.gov Menu

Cord Blood Transplantation for Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359254
Recruitment Status : Terminated (did not accrue enough patients.)
First Posted : May 24, 2011
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The primary objective of this study is 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 or disease Intervention/treatment Phase
Hematological Disease Drug: Melphalan Drug: Fludarabine Drug: Antithymocyte Globulin (ATG) Drug: Busulfan Drug: Total Body Irradiation (TBI) Phase 2

Detailed Description:

Primary Objective

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

Secondary Objectives

  • To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
  • To describe the incidence and severity of acute and chronic GVHD.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
Study Start Date : April 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fludarabine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Drug: Melphalan
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Other Names:
  • Alkeran
  • Sarcolysin
Drug: Fludarabine
Fludarabine is given through the vein daily for 5 days.
Other Names:
  • fludarabine phosphate
  • Fludara
Drug: Antithymocyte Globulin (ATG)
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
Fludarabine is given through the vein daily for 5 days.
Other Names:
  • fludarabine phosphate
  • Fludara
Drug: Antithymocyte Globulin (ATG)
ATG is given every other day for 4 days.
Drug: Busulfan
Busulfan is given daily for 4 days.
Other Names:
  • Myleran
  • Busulfex IV
Drug: Total Body Irradiation (TBI)
TBI is given twice on the last day.



Primary Outcome Measures :
  1. Cord Blood Engraftment by Day 100 [ Time Frame: 100 days ]

    Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.

    As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.



Secondary Outcome Measures :
  1. Survival at Day 100 [ Time Frame: 100 days ]
    Percent of subjects who are alive 100 days after the stem cell infusion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01359254     History of Changes
Other Study ID Numbers: 10-020-B
First Posted: May 24, 2011    Key Record Dates
Results First Posted: April 30, 2015
Last Update Posted: April 30, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hematologic Diseases
Fludarabine
Fludarabine phosphate
Melphalan
Busulfan
Antilymphocyte Serum
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists