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Clinical Trials/NCT01359254
NCT01359254TerminatedPhase 2

Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies

University of Chicago1 site in 1 country1 target enrollmentStarted: April 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
1
Locations
1
Primary Endpoint
Cord Blood Engraftment by Day 100

Study Overview

Brief Summary

The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.

Detailed Description

Primary Objective

  • To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease

Secondary Objectives

  • To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
  • To describe the incidence and severity of acute and chronic GVHD.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • 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

Arms & Interventions

Conditioning Regimen II

Experimental

Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).

Intervention: Antithymocyte Globulin (ATG) (Drug)

Conditioning Regimen I

Experimental

Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)

Intervention: Melphalan (Drug)

Conditioning Regimen I

Experimental

Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)

Intervention: Fludarabine (Drug)

Conditioning Regimen I

Experimental

Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)

Intervention: Antithymocyte Globulin (ATG) (Drug)

Conditioning Regimen II

Experimental

Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).

Intervention: Fludarabine (Drug)

Conditioning Regimen II

Experimental

Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).

Intervention: Busulfan (Drug)

Conditioning Regimen II

Experimental

Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).

Intervention: Total Body Irradiation (TBI) (Drug)

Outcomes

Primary Outcomes

Cord Blood Engraftment by Day 100

Time Frame: 100 days

Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.

Secondary Outcomes

  • Survival at Day 100(100 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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