Haploid Allogeneic Transplant Using the CliniMACS System

NCT ID: NCT00185679

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2010-02-28

Brief Summary

To assess the proportion of patients with donor neutrophil engraftment within 30 days of allogeneic transplant. To assess the incidence of acute GvHD during the first 100 days after transplantation.

Detailed Description

To assess the proportion of patients with donor neutrophil engraftment within 30 days of allogeneic transplant; assess the incidence of acute GvHD during the first 100 days after transplantation; and assess platelet engraftment, graft failure, chronic GvHD, clinical safety, and devise performance.

Conditions

Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors; Chronic Myelogenous Leukemia (CML) - Accelerated or Second Chronic Phase; Myelodysplastic Syndrome (MDS) - High and Intermediate Risk; Non-Hodgkin's Lymphoma (NHL); Chronic Lymphocytic Leukemia (CLL) - Refractory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Haploidentical Allogeneic Transplant Using CliniMACS System

The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.

Group Type: EXPERIMENTAL

CliniMACS System

Intervention Type: DEVICE

The CliniMACS System is a cell selection device consisting of the following components:

1. Computer-controlled instrument;

2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)

3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)

4. Wash buffer

Interventions

CliniMACS System

The CliniMACS System is a cell selection device consisting of the following components:

1. Computer-controlled instrument;

2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)

3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)

4. Wash buffer

Intervention Type: DEVICE

Other Intervention Names

CliniMACS Cell Selection System

Eligibility Criteria

Inclusion Criteria

Histopathologically-confirmed diagnosis of hematological or lymphatic malignancy, defined as one of the following:

• Acute myeloid leukemia (AML) as primary refractory disease, or in relapse
• Acute leukemia in first remission with poor risk factors and molecular prognosis
• AML with -5,-7, t(6;9), tri8, -11
• Acute lymphocytic / lymphoblastic leukemia (ALL) with Phil+ t(9;22),(q34;q11.2), and t(4:11)(q21;23)
• Chronic myelogenous leukemia (CML in accelerated, second chronic phase
• Myelodysplastic syndrome with high intermediate to high risk categories
• Non-Hodgkin's lymphoma (NHL)
• Chronic lymphocytic leukemia (CLL), Refractory < 50 years old at time of registration Donor is related Donor is genotypically-matched and haploidentical for HLA-A, B,C and DRB1, DQ loci Donor differs for 2 or 3 HLA alleles on the unshared haplotype in the GvHD direction No HLA-matched sibling or matched unrelated donor is identified ECOG performance status not more than 2 LVEF > 45% DLCO > 50% corrected for hemoglobin Serum creatinine
• < 1.5 mg/dL OR
• creatinine clearance > 50 mL/min for those above serum creatinine of 1.5 mg/dL serum bilirubin < 2.0 mg/dL ALT < 2x ULN (unless secondary to disease) Females of childbearing potential must have a negative serum or urine beta-HCG test within 3 weeks of registration No prior cancer within 5 years with the exception of surgically-cured, non-melanoma skin cancer or in situ cancer of the cervix No prior myeloablative therapy or transplant Duly-executed informed consent

• Must be seronegative donor if recipeint is seronegative.
• Otherwise the donor will be selected on the ability of NK cell alloreactivity based upon HLA typing results and donors who are capable of NK cell alloreactivity will be used preferentially.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ginna Laport

OTHER

Sponsor Role: lead

Responsible Party

Ginna Laport

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ginna G Laport, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

BMT123

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00424

Identifier Type: OTHER

Identifier Source: secondary_id

77453

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-12600

Identifier Type: -

Identifier Source: org_study_id