Combined Haploidentical-Cord Blood Transplantation for Adults and Children

January 8, 2021 updated by: University of Chicago
The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation.

  1. Relapsed or refractory acute leukemia (myeloid or lymphoid)
  2. Acute leukemia in first remission at high-risk for recurrence
  3. Chronic myelogenous leukemia in accelerated phase or blast-crisis
  4. Chronic myelogenous leukemia in chronic phase
  5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
  6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features
  7. Multiple myeloma
  8. Myelodysplastic syndrome
  9. Chronic myeloproliferative disease
  10. Hemoglobinopathies
  11. Aplastic anemia

Exclusion Criteria:

  1. Zubrod performance status > 2
  2. Life expectancy is severely limited by concomitant illness
  3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)
  4. Estimated Creatinine Clearance <50 ml/min
  5. Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
  6. Evidence of chronic active hepatitis or cirrhosis
  7. HIV-positive
  8. Patient is pregnant
  9. Patient or guardian not able to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Good Risks patients
For patients transplanted in remission.
Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.
Procedure: Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Procedure: Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Experimental: High Risk Patients eligible for radiation
Procedure: Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Procedure: Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
Experimental: High Risk Patients not eligible for radiation
Procedure: Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Procedure: Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Drug: Fludarabine, Busulfan, and ATG
Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Neutrophil Engraftment
Time Frame: Transplant (Day 0) through Day +28
Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC <500/mm3 and platelet count < 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity < 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to < 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.
Transplant (Day 0) through Day +28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
Time Frame: Up to 2 years

Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).

Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al)

The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported
Up to 2 years
Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years
Time Frame: up to 5 years
We reported overall survival at 2 years and 5 years after transplant
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Hongtao Liu, M.D., University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2006

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14736B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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