Cord Blood Transplantation for Patients With Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Hematological Disease
• Intervention / Treatment: Drug: Melphalan; Drug: Fludarabine; Drug: Antithymocyte Globulin (ATG); Drug: Busulfan; Drug: Total Body Irradiation (TBI)

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conditioning Regimen I; Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)	Drug: Melphalan; Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.; Other Names: Alkeran; Sarcolysin; Drug: Fludarabine; Fludarabine is given through the vein daily for 5 days.; Other Names: Fludara; fludarabine phosphate; Drug: Antithymocyte Globulin (ATG); ATG is given every other day for 4 days.
EXPERIMENTAL: Conditioning Regimen II; Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).	Drug: Fludarabine; Fludarabine is given through the vein daily for 5 days.; Other Names: Fludara; fludarabine phosphate; Drug: Antithymocyte Globulin (ATG); ATG is given every other day for 4 days.; Drug: Busulfan; Busulfan is given daily for 4 days.; Other Names: Myleran; Busulfex IV; Drug: Total Body Irradiation (TBI); TBI is given twice on the last day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at Day 100	Percent of subjects who are alive 100 days after the stem cell infusion	100 days

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (ESTIMATE): May 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Melphalan; Fludarabine; Fludarabine phosphate; Busulfan; Antilymphocyte Serum
• Other Study ID Numbers: 10-020-B