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Completed

NCT Number: NCT00943800

Combined Haploidentical-Cord Blood Transplantation for Adults and Children

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).

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Key information

Conditions

Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)

Drug

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.

Stem Cell Transplant

Procedure

Infusion of haploidentical donor, umbilical cord blood

Stem Cells Collections

Procedure

Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.

Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)

Drug

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, Busulfan, and ATG

Drug

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.

Primary outcomes

  1. Percentage of Participants With Neutrophil Engraftment

    Time frame: Transplant (Day 0) through Day +28

    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.

Secondary outcomes

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

    Time frame: Up to 2 years

    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

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

    Time frame: up to 5 years

    We reported overall survival at 2 years and 5 years after transplant

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2009
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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