Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00477035
First received: May 18, 2007
Last updated: May 19, 2011
Last verified: May 2011

May 18, 2007
May 19, 2011
May 2006
March 2011   (final data collection date for primary outcome measure)
  • To document the toxicities of infusion of autologous CIK cells [ Time Frame: Day 42 post autologous stem cell transplant ] [ Designated as safety issue: Yes ]
  • Measure freedom from progression (FFP) [ Time Frame: 1 and 2 years post-transplant ] [ Designated as safety issue: No ]
  • Measure event free survival [ Time Frame: 1 and 2 years post-transplant ] [ Designated as safety issue: No ]
  • Measure overall survival [ Time Frame: 1 and 2 years post-transplant ] [ Designated as safety issue: No ]
  • Toxicities of infusion of autologous CIK cells [ Time Frame: day 42 post-autologous stem cell transplant ]
  • Freedom from progression (FFP), event-free survival (EFS), and overall survival (OS) [ Time Frame: one year ]
Complete list of historical versions of study NCT00477035 on ClinicalTrials.gov Archive Site
Measure disease response [ Time Frame: at day 40-60, day 90, day 180, and yearly ] [ Designated as safety issue: No ]
  • Disease response [ Time Frame: day 40, day 90, day 180, and yearly ]
  • FFP, EFS, OS [ Time Frame: two years ]
Not Provided
Not Provided
 
Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies
A Phase I/II Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies

The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.

Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Leukemia
  • Multiple Myeloma
  • Drug: CIK cells
    2x10e8 cells/kg
    Other Name: autologous cytokine-induced killer cells
  • Drug: busulfan
    1 mg/kg
    Other Names:
    • Myleran
    • Busulfex IV
  • Drug: etoposide
    60 mg/kg
    Other Names:
    • Eposin
    • Etopophos
    • Vepesid
    • VP-16
  • Drug: bcnu
    15 mg/kg
    Other Name: Carmustine
  • Drug: cyclophosphamide
    100 mg/kg
    Other Names:
    • Endoxan
    • Cytoxan
    • Neosar
    • Procytox
    • Revimmune
    • cytophosphane
  • Drug: gemcitabine
    1250 mg/m2
    Other Name: Gemzar
  • Drug: vinorelbine
    30 mg/m2
    Other Name: Navelbine
  • Drug: melphalan
    200 mg/m2
    Other Names:
    • Alkeran
    • Melphalan hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients between 18 and 75 years of age, inclusive candidates for standard autologous SCT who are at high risk for relapse:

    • Acute myelogenous leukemia (AML), high risk, in CR1 or beyond without a donor (CR1 defined as: normal bone marrow morphology, resolution of any previously abnormal karyotype, neutrophils > 1000/ul, platelets > 100,000/ul, independence from red cell transfusion, no evidence extramedullary leukemia)
    • Hodgkin's lymphoma relapsed or refractory, with the presence of >= 1 adverse risk factor (Adverse risk factors are defined as stage IV involvement of the lung or bone marrow, constitutional symptoms, and the presence of more than minimal residual disease before the preparatory regimen)
    • Multiple myeloma with high risk features with only single autologous transplant option. High risk features defined as IgA myeloma, B2M > 2.5 mg/ml with normal kidney function, complex karyotypes or isolated chromosome 13 abnormalities, standard-dose therapy > 12 months, or inability to achieve at least 50% reduction of plasma cells in the bone marrow or 50% reduction in the paraprotein concentration after initial induction chemotherapy prior to transplant.
  • Patients must have ECOG performance status < 2
  • Patients must have adequate renal function with a serum creatinine of < 2 mg/dl or creatinine clearance > 50 ml/min.
  • Patients must have adequate liver function with a total bilirubin < 2 mg/dl or transaminases < 3 times the upper limit of normal.
  • Patients must have negative antibody serology for human immunodeficiency virus (HIV1 and 2)
  • Adult women and minorities will be included. Patients with childbearing potential must use effective contraception.
  • Patients must sign informed consent prior to initiation of any study-related treatments.

Exclusion Criteria:

  • ECOG performance status > 2
  • LVEF < 45%
  • Pulmonary diffusion capacity < 50% predicted
  • Total bilirubin > 2 mg/dl
  • Creatinine > 2 mg/dl
  • Pregnancy
  • Patients positive for HIV
  • Patients with engraftment failure at day 42 post transplant defined as failure to achieve a granulocyte count > 500/ul on 3 successive daily determinations and an unsupported platelet count of >= 50,000/ul by day 42
  • Patients with active, uncontrolled infection that is expected to continue beyond day 42-63.
  • Patients who fail to collect sufficient quantities of stem cells (> 1.6 x 10^9 cells) during apheresis to support CIK cell expansion cultures.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477035
BMT173, 95889, BMT173
Yes
Sally Arai, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Sally Arai Stanford University
Stanford University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP