Combined Haploidentical-Cord Blood Transplantation for Adults and Children
This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
University of Chicago
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00943800
First received: July 20, 2009
Last updated: June 22, 2012
Last verified: June 2012
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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:
Drug Information available for:
Thiotepa
Busulfan
Melphalan
Melphalan hydrochloride
Fludarabine
Fludarabine phosphate
Antilymphocyte Serum
U.S. FDA Resources
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 2015 |
| Estimated Primary Completion Date: | October 2013 (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.
- 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(PFT's)
- 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
Contacts and Locations
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: | Andrew Artz, MD, Assistant Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00943800 History of Changes |
| Other Study ID Numbers: | 14736B |
| Study First Received: | July 20, 2009 |
| Last Updated: | June 22, 2012 |
| 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 monophosphate Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013