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Haploid Allogeneic Transplant Using the CliniMACS System

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CliniMACS System
Sponsored by
Ginna Laport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Haploidentical Allogeneic Transplant Using CliniMACS System

Arm Description

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.

Outcomes

Primary Outcome Measures

Neutrophil Engraftment
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)
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
Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions

Full Information

First Posted
September 12, 2005
Last Updated
February 26, 2015
Sponsor
Ginna Laport
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1. Study Identification

Unique Protocol Identification Number
NCT00185679
Brief Title
Haploid Allogeneic Transplant Using the CliniMACS System
Official Title
A Feasibility Study Evaluating Haploidentical Allogeneic Transplantation Using the CliniMACS System in Patients With Advanced Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
This study was superseded by the subsequent study IRB-15919 (NCT01050764)
Study Start Date
November 2001 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ginna Laport

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haploidentical Allogeneic Transplant Using CliniMACS System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CliniMACS System
Other Intervention Name(s)
CliniMACS Cell Selection System
Intervention Description
The CliniMACS System is a cell selection device consisting of the following components: Computer-controlled instrument; Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix) Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle) Wash buffer
Primary Outcome Measure Information:
Title
Neutrophil Engraftment
Description
Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L
Time Frame
30 days post-transplant
Secondary Outcome Measure Information:
Title
Acute GvHD (Grade II-IV)
Description
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).
Time Frame
within 100 days post-transplant
Title
Platelet Recovery
Description
Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions
Time Frame
40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ginna G Laport, MD
Organizational Affiliation
Stanford Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Haploid Allogeneic Transplant Using the CliniMACS System

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