Haploid Allogeneic Transplant Using the CliniMACS System

This study has been terminated.
(This study was superseded by the subsequent study IRB-15919 (NCT01050764))
Sponsor:
Information provided by (Responsible Party):
Ginna Laport, Stanford University
ClinicalTrials.gov Identifier:
NCT00185679
First received: September 12, 2005
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
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
Device: CliniMACS System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study Evaluating Haploidentical Allogeneic Transplantation Using the CliniMACS System in Patients With Advanced Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Neutrophil Engraftment [ Time Frame: 30 days post-transplant ] [ Designated as safety issue: Yes ]
    Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L


Secondary Outcome Measures:
  • Acute GvHD (Grade II-IV) [ Time Frame: within 100 days post-transplant ] [ Designated as safety issue: Yes ]
    Number of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).

  • Platelet Recovery [ Time Frame: 40 days ] [ Designated as safety issue: No ]
    Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions


Enrollment: 13
Study Start Date: November 2001
Study Completion Date: February 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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
Other Name: CliniMACS Cell Selection System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

RECIPIENT 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

RECIPIENT EXCLUSION CRITERIA Suitable candidate for autologous transplantation Participation in other investigational drugs or devices trials that might influence the study endpoints Evidence of active hepatitis Evidence of active cirrhosis HIV-positive History of invasive aspergillosis Presence of any other uncontrolled, active infection, ie, bacterial, viral or fungal Uncontrolled CNS involvement Documented allergy to murine proteins Documented allergy to iron dextran Lactating female Female of child-bearing potential unwilling to implement adequate birth control Medical problem / neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and/or to tolerate transplantation, in the opinion of the principal investigator Medical problem / neurologic/psychiatric dysfunction which would prolong hematologic recovery and place the recipient at unacceptable risk, in the opinion of the principal investigator would .

DONOR INCLUSION CRITERIA Age < 60 years Weight > 25 kg Medical history and physical examination confirm good health status as defined by institutional standards Within 30 days of apheresis collection, seronegative for HIV assessed as HIV Ag; HIV 1+2 Ab; or HTLV I/II Ab Within 30 days of apheresis collection, seronegative for hepatitis assessed as HBsAg; HBcAb (IgM and IgG); or HCV Ab Within 30 days of apheresis collection, seronegative for syphilis assessed as RPR Genotypically haploidentical as determined by HLA typing Female donors of child-bearing potential must have a negative serum or urine beta-HCG test within 3 weeks of mobilization Capable of undergoing leukapheresis Has adequate venous access Willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate Agreeable to second donation of PBPC (or a bone marrow harvest) should the recipient fail to demonstrate sustained engraftment following the transplant Duly-executed informed consent Screened for CMV seroreactivity

  • 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.

DONOR EXCLUSION CRITERIA Evidence of active infection (including urinary tract infection, or upper respiratory tract infection) Evidence of hepatitis (on screening) Medical, physical or psychological reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis Factors placing donor at increased risk for leukapheresis or G-CSF-related complications Lactating female Female of child-bearing potential unwilling to implement adequate birth control HIV-positive

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00185679

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Ginna Laport
Investigators
Principal Investigator: Ginna G Laport, MD Stanford Cancer Institute
  More Information

No publications provided

Responsible Party: Ginna Laport, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00185679     History of Changes
Other Study ID Numbers: IRB-12600, BMT123, NCI-2011-00424, 77453
Study First Received: September 12, 2005
Results First Received: February 26, 2015
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on March 31, 2015