Haploid Allogeneic Transplant Using the CliniMACS System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ginna Laport, Stanford University
ClinicalTrials.gov Identifier:
NCT00185679
First received: September 12, 2005
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

To assess the proportion of patients with donor neutrophil engraftment on or before day 30 post transplant. To assess the incidence of acute GvHD during the first 100 days after transplantation.


Condition Intervention Phase
Leukemia
Lymphoma
Device: CliniMACS
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:
  • Donor neutrophil engraftment [ Time Frame: 30 days after transplant ] [ Designated as safety issue: Yes ]
  • Incidence of acute GvHD (grade II-IV) [ Time Frame: first 100 days after transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Platelet engraftment [ Time Frame: 30 days after transplant ] [ Designated as safety issue: Yes ]
  • Incidence of graft failure and chronic GvHD [ Time Frame: ailure first 100 days after transplant and 100 days after transplant and beyond ] [ Designated as safety issue: Yes ]
  • Overall and disease free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Clinical safety and device performance [ Time Frame: up to day of transplant ] [ Designated as safety issue: Yes ]

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: CliniMACS System Device: CliniMACS

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

1) computer-controlled instrument; 2) sterile disposable tubing set made up of PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix; 3) antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle) specific for CD34+ cells; and 4) wash buffer

Other Name: Cell Selection System

Detailed Description:

To assess the proportion of patients with donor neutrophil engraftment on or before day 30 post 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

Inclusion Criteria:4.1. Recipient Inclusion Criteria

4.1.1. Male or female recipients must have histopathologically confirmed diagnosis of hematological or lymphatic malignancy in one of the following categories: 4.1.1.1. Acute myeloid leukemia (in relapse or primary refractory disease) 4.1.1.2. Acute leukemia (in first remission with poor risk factors and molecular prognosis; AML with -5,-7, t(6;9), tri8, -11 and ALL with Phil+ t(9;22),(q34;q11.2), and t(4:11)(q21;23) 4.1.1.3. Chronic myelogenous leukemia (accelerated, second chronic phase) 4.1.1.4. Myelodysplastic syndrome (in high and high intermediate risk categories) 4.1.1.5. Non-Hodgkin's lymphoma ) 4.1.1.6. Refractory CLL

4.1.2. The recipient must be < 50 years old at time of registration.

4.1.3. The recipient must have a related donor genotypically HLA-A, B,C and DRB1, DQ loci haploidentical to the recipient (but differing for 2-3 HLA alleles on the unshared haplotype in the GvHD direction) and no HLA matched sibling or matched unrelated donor is identified.

4.1.4. Recovery from prior therapy, chemotherapy, or radiotherapy, as defined by: 4.1.4.1. ECOG performance status < 2

4.1.5. Adequate cardiac and pulmonary function (LVEF > 45%, DLCO > 50% corrected for hemoglobin)

4.1.6. Serum creatinine < 1.5 mg/dL or creatinine clearance > 50 ml/min for those above serum creatinine of 1.5; serum bilirubin < 2.0 mg/dL; ALT < 2x ULN (unless secondary to disease)

4.1.7. Females of childbearing potential must have a negative serum or urine beta-HCG test within three weeks of registration. Additionally, patients will be required to take adequate contraceptive measures.

4.1.8. No prior cancer within five years with the exception of surgically cured non-melanoma skin cancer or in situ cancer of the cervix

4.1.9. No prior myeloablative therapy or transplant

4.1.10. The recipient and/or the recipient's legal guardian must have been informed of the investigational nature of this study and have signed a consent form which is in accordance with Federal guidelines and the guidelines of the Stanford IRB.

4.2. Recipient Exclusion Criteria

4.2.1. The recipient is a suitable candidate for autologous transplantation.

4.2.2. Participation in other clinical trials which involve investigational drugs or devices that might influence the endpoints of this study

4.2.3. Evidence of active hepatitis or cirrhosis

4.2.4. HIV positive

4.2.5. History of invasive aspergillosis; presence of any other active, uncontrolled bacterial, viral or fungal infection

4.2.6. Uncontrolled CNS involvement

4.2.7. Documented allergy to murine proteins or iron dextran

4.2.8. The recipient is a lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control.

4.2.9. The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk.

4.3. Donor Inclusion Criteria

The donor must be examined and have specific tests performed according to existing institutional guidelines to evaluate his/her candidacy as a donor including the following:

4.3.1. Age < 60 years and weight greater than 25 kg.

4.3.2. Medical history and physical examination confirm good health status as defined by institutional standards

4.3.3. Seronegative for HIV Ag, HIV 1+2 Ab, HTLV I/II Ab, HBsAg, HBcAb (IgM and IgG), HCV Ab, RPR for syphilis within 30 days of apheresis collection

4.3.4. Genotypically haploidentical as determined by HLA typing

4.3.5. Female donors of child-bearing potential must have a negative serum or urine beta-HCG test within three weeks of mobilization

4.3.6. Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate

4.3.7. Agreeable to second donation of PBPC (or a bone marrow harvest) should the patient fail to demonstrate sustained engraftment following the transplant.

4.3.8. The donor, or legal guardian greater than 18 years of age, must have been informed of the investigational nature of this study and have signed a consent form in accordance with Federal Guidelines and the guidelines of the Stanford IRB.

4.3.9. The prospective donor will be screened for CMV seroreactivity and a seronegative donor will be utilized if available when the patient 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.

Exclusion Criteria:4.2. Recipient Exclusion Criteria

4.2.1. The recipient is a suitable candidate for autologous transplantation.

4.2.2. Participation in other clinical trials which involve investigational drugs or devices that might influence the endpoints of this study

4.2.3. Evidence of active hepatitis or cirrhosis

4.2.4. HIV positive

4.2.5. History of invasive aspergillosis; presence of any other active, uncontrolled bacterial, viral or fungal infection

4.2.6. Uncontrolled CNS involvement

4.2.7. Documented allergy to murine proteins or iron dextran

4.2.8. The recipient is a lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control.

4.2.9. The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk.

4.4. Donor Exclusion Criteria

4.4.1. Evidence of active infection (including urinary tract infection, or upper respiratory tract infection) or hepatitis (on screening )

4.4.2. Medical, physical or psychological reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.

4.4.3. Factors which place the donor at increased risk for complications from leukapheresis or G-CSF therapy.

4.4.4. Lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control.

4.4.5. 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 Laport Stanford University
  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: BMT123, 12600
Study First Received: September 12, 2005
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014