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Combined Haploidentical-Cord Blood Transplantation for Adults and Children

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943800
First Posted: July 22, 2009
Last Update Posted: July 6, 2017
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.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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).

Condition Intervention
Leukemia Myelodysplastic Syndrome Multiple Myeloma Lymphoma Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG) Procedure: Stem Cell Transplant Procedure: Stem Cells Collections Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI) Drug: Fludarabine, Busulfan, and ATG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Haploidentical-Cord Blood Transplantation for Adults and Children

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To assess the rate of engraftment with combined haploidentical-cord blood [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • To assess the rates of GVHD with combined haploidentical-cord blood (acute & chronic) [ Time Frame: 1 year ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00943800


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

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00943800     History of Changes
Other Study ID Numbers: 14736B
First Submitted: July 20, 2009
First Posted: July 22, 2009
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by University of Chicago:
Appropriate candidate for transplantation
An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.

Additional relevant MeSH terms:
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Fludarabine
Fludarabine phosphate
Melphalan
Busulfan
Thiotepa
Antilymphocyte Serum
Thymoglobulin
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action