Cord Blood Transplantation for Patients With Cancer

Hematological Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01359254
• Other study ID #: 10-020-B
• Status: Terminated
• Phase: Phase 2
• First received: May 20, 2011
• Last updated: April 10, 2015
• Start date: April 2010
• Est. completion date: June 2012

Study information

• Verified date: April 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Disease

Intervention

Drug:
• Melphalan
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
• Fludarabine
Fludarabine is given through the vein daily for 5 days.
• Antithymocyte Globulin (ATG)
ATG is given every other day for 4 days.
• Busulfan
Busulfan is given daily for 4 days.
• Total Body Irradiation (TBI)
TBI is given twice on the last day.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cord Blood Engraftment by Day 100	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.	100 days	No
Secondary	Survival at Day 100	Percent of subjects who are alive 100 days after the stem cell infusion	100 days	No