Combined Haploidentical-Cord Blood Transplantation for Adults and Children
1 other identifier
interventional
87
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable leukemia
Started Oct 2006
Longer than P75 for not_applicable leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2006
CompletedFirst Submitted
Initial submission to the registry
July 20, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedResults Posted
Study results publicly available
October 27, 2020
CompletedJanuary 27, 2021
January 1, 2021
11.9 years
July 20, 2009
October 5, 2020
January 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Neutrophil Engraftment
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 Outcomes (2)
Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
Up to 2 years
Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years
up to 5 years
Study Arms (3)
Good Risks patients
EXPERIMENTALFor patients transplanted in remission.
High Risk Patients eligible for radiation
EXPERIMENTALHigh Risk Patients not eligible for radiation
EXPERIMENTALInterventions
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.
Infusion of haploidentical donor, umbilical cord blood
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (2)
Liu H, Rich ES, Godley L, Odenike O, Joseph L, Marino S, Kline J, Nguyen V, Cunningham J, Larson RA, del Cerro P, Schroeder L, Pape L, Stock W, Wickrema A, Artz AS, van Besien K. Reduced-intensity conditioning with combined haploidentical and cord blood transplantation results in rapid engraftment, low GVHD, and durable remissions. Blood. 2011 Dec 8;118(24):6438-45. doi: 10.1182/blood-2011-08-372508. Epub 2011 Oct 5.
PMID: 21976674RESULTvan Besien K, Hari P, Zhang MJ, Liu HT, Stock W, Godley L, Odenike O, Larson R, Bishop M, Wickrema A, Gergis U, Mayer S, Shore T, Tsai S, Rhodes J, Cushing MM, Korman S, Artz A. Reduced intensity haplo plus single cord transplant compared to double cord transplant: improved engraftment and graft-versus-host disease-free, relapse-free survival. Haematologica. 2016 May;101(5):634-43. doi: 10.3324/haematol.2015.138594. Epub 2016 Feb 11.
PMID: 26869630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hongtao Liu
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Hongtao Liu, M.D.
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2009
First Posted
July 22, 2009
Study Start
October 9, 2006
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
January 27, 2021
Results First Posted
October 27, 2020
Record last verified: 2021-01