NCT00943800 · REGISTRY CONDITION SEARCH

Combined Haploidentical-Cord Blood Transplantation for Adults and Children

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2021-01-27

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Neutrophil Engraftment

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outcome · POSTED

Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)

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outcome · POSTED

Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 1 Year
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
For patients transplanted in remission.
intervention Names
Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
Procedure: Stem Cell Transplant
Procedure: Stem Cells Collections
label
Good Risks patients
type
EXPERIMENTAL
intervention Names
Procedure: Stem Cell Transplant
Procedure: Stem Cells Collections
Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
label
High Risk Patients eligible for radiation
type
EXPERIMENTAL
intervention Names
Procedure: Stem Cell Transplant
Procedure: Stem Cells Collections
Drug: Fludarabine, Busulfan, and ATG
label
High Risk Patients not eligible for radiation
type
EXPERIMENTAL

interventions

arm Group Labels
Good Risks patients
description
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.
name
Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
type
DRUG
arm Group Labels
Good Risks patients
High Risk Patients eligible for radiation
High Risk Patients not eligible for radiation
description
Infusion of haploidentical donor, umbilical cord blood
name
Stem Cell Transplant
type
PROCEDURE
arm Group Labels
Good Risks patients
High Risk Patients eligible for radiation
High Risk Patients not eligible for radiation
description
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
name
Stem Cells Collections
type
PROCEDURE
arm Group Labels
High Risk Patients eligible for radiation
description
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.
name
Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
type
DRUG
arm Group Labels
High Risk Patients not eligible for radiation
description
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.
name
Fludarabine, Busulfan, and ATG
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 87
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Percentage of Participants With Neutrophil Engraftment
time Frame
Transplant (Day 0) through Day +28

secondary Outcomes

description
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
measure
Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
time Frame
Up to 2 years
description
We reported overall survival at 2 years and 5 years after transplant
measure
Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years
time Frame
up to 5 years

Full study description

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).

Source references

references

citation
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
21976674
type
RESULT
citation
van 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
26869630
type
DERIVED

Source notices and limitations

Discovery and provenance

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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice