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Cord Blood Transplantation for Patients With Cancer

Primary Purpose

Hematological Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melphalan
Fludarabine
Antithymocyte Globulin (ATG)
Busulfan
Total Body Irradiation (TBI)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conditioning Regimen I

Conditioning Regimen II

Arm Description

Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)

Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).

Outcomes

Primary Outcome Measures

Cord Blood Engraftment by Day 100
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

Survival at Day 100
Percent of subjects who are alive 100 days after the stem cell infusion

Full Information

First Posted
May 20, 2011
Last Updated
April 10, 2015
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01359254
Brief Title
Cord Blood Transplantation for Patients With Cancer
Official Title
Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
did not accrue enough patients.
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conditioning Regimen I
Arm Type
Experimental
Arm Description
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Arm Title
Conditioning Regimen II
Arm Type
Experimental
Arm Description
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran, Sarcolysin
Intervention Description
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
fludarabine phosphate, Fludara
Intervention Description
Fludarabine is given through the vein daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
Antithymocyte Globulin (ATG)
Intervention Description
ATG is given every other day for 4 days.
Intervention Type
Drug
Intervention Name(s)
Busulfan
Other Intervention Name(s)
Myleran, Busulfex IV
Intervention Description
Busulfan is given daily for 4 days.
Intervention Type
Drug
Intervention Name(s)
Total Body Irradiation (TBI)
Intervention Description
TBI is given twice on the last day.
Primary Outcome Measure Information:
Title
Cord Blood Engraftment by Day 100
Description
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.
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Survival at Day 100
Description
Percent of subjects who are alive 100 days after the stem cell infusion
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Artz, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Cord Blood Transplantation for Patients With Cancer

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