Combined Haploidentical-Cord Blood Transplantation for Adults and Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00943800
First received: July 20, 2009
Last updated: March 11, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943800

Contacts
Contact: Andrew Artz, M.D. 773-834-8980 aartz@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Andrew Artz, M.D.    773-834-8980    aartz@medicine.bsd.uchicago.edu   
Contact: Paula Del Cerro    773-702-2070    pdelcerr@medicine.bsd.uchicago.edu   
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
Study First Received: July 20, 2009
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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:
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Antilymphocyte Serum
Busulfan
Melphalan
Thiotepa
Fludarabine phosphate
Fludarabine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014