Cord Blood Transplantation for Patients With Cancer

The University of Chicago

Status and phase: Terminated; Phase 2

Conditions: Hematological Disease

Treatments: Drug: Melphalan; Drug: Busulfan; Drug: Total Body Irradiation (TBI); Drug: Fludarabine; Drug: Antithymocyte Globulin (ATG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01359254

10-020-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Conditioning Regimen I

Experimental group

Description:

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

Treatment:

Drug: Fludarabine

Drug: Antithymocyte Globulin (ATG)

Drug: Melphalan

Conditioning Regimen II

Experimental group

Description:

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

Treatment:

Drug: Fludarabine

Drug: Total Body Irradiation (TBI)

Drug: Antithymocyte Globulin (ATG)

Drug: Busulfan