Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00185679
Other study ID # IRB-12600
Secondary ID BMT123NCI-2011-0
Status Terminated
Phase Phase 2
First received September 12, 2005
Last updated February 26, 2015
Start date November 2001
Est. completion date February 2010

Study information

Verified date February 2015
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date February 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
CliniMACS System
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

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Ginna Laport

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neutrophil Engraftment Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L 30 days post-transplant Yes
Secondary 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). within 100 days post-transplant Yes
Secondary Platelet Recovery Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions 40 days No
See also
  Status Clinical Trial Phase
Completed NCT01448928 - Zevalin Post-marketing Surveillance in Japan
Terminated NCT00089284 - Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL Phase 1/Phase 2
Unknown status NCT01983761 - Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01108341 - Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL) Phase 2
Completed NCT00129090 - Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma Phase 3
Completed NCT01527838 - Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit Phase 1
Completed NCT00923910 - Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood Phase 1/Phase 2
Completed NCT00614042 - Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma Phase 1
Completed NCT02071888 - Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors Phase 1
Recruiting NCT04696705 - Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients Early Phase 1
Completed NCT01479387 - Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan N/A
Completed NCT00889798 - Tumor Registry of Lymphatic Neoplasia
Terminated NCT05144347 - Study of XL114 in Subjects With Non-Hodgkin's Lymphoma Phase 1