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A Phase I/II Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Leukemia, Multiple Myeloma

Thank you

Trial Information

A Phase I/II Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of 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.

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

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

- Patients who fail to collect sufficient quantities of stem cells (> 1.6 x 10^9 cells)
during apheresis to support CIK cell expansion cultures.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To document the toxicities of infusion of autologous CIK cells

Outcome Time Frame:

Day 42 post autologous stem cell transplant

Safety Issue:


Principal Investigator

Sally Arai

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

May 2006

Completion Date:

March 2011

Related Keywords:

  • Leukemia
  • Multiple Myeloma
  • Leukemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms



Stanford University School of MedicineStanford, California  94305-5317