Haploid Allogeneic Transplant Using the CliniMACS System

NCT00185679 | Terminated Phase 2 Results DMC

• 4 other identifiers: IRB-12600BMT123NCI-2011-0042477453
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Neutrophil Engraftment

  Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC \> 0.5x10e9/L

  30 days post-transplant

Secondary Outcomes (2)

• Acute GvHD (Grade II-IV)

  within 100 days post-transplant

• Platelet Recovery

  40 days

Study Arms (1)

Haploidentical Allogeneic Transplant Using CliniMACS System

EXPERIMENTAL

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.

Device: CliniMACS System

Interventions

CliniMACS System 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

Also known as: CliniMACS Cell Selection System

Haploidentical Allogeneic Transplant Using CliniMACS System

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ginna Laport: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid

Results Point of Contact

• Title: Ginna G Laport, MD
• Organization: Stanford Cancer Institute

ginna.laport@stanford.edu

650-723-8222

Study Officials

• Ginna G Laport, MD

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2001
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 9, 2015
• Results First Posted: March 9, 2015

Record last verified: 2015-02

Locations

US (1)