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HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies

Phase 1
13 Years
70 Years
Not Enrolling
Lymphoma, Myeloma, Leukemia

Thank you

Trial Information

HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies

Natural killer cells are blood cells that are responsible for eliminating cancer cells
especially when there are only a few. It has been shown that NK cells coming from a
"mismatched" person (a relative) have a better chance than the patient's own NK cells to
recognize and kill cancer cells. These cells will be collected from the blood of a parent,
child or sibling and after preparation in the laboratory, will be given to the patient early
after an autologous stem cell transplantation like a blood or platelet transfusion. A person
who has been diagnosed with a blood tumor and received an autologous stem cell transplant
has the chance of his/her cancer coming back. This study uses NK cells obtained from a
relative to prevent disease recurrence by potentially eliminating and eradicating any
residual cancerous cells.

Inclusion Criteria:

- Patients who have undergone an autologous stem cell transplant for the following

- Acute Myeloid Leukemia

- Non-Hodgkin's Lymphoma

- Hodgkin's Disease

- Multiple Myeloma

- Age 13 - 70 years old

- Able to give informed consent

- Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST
and ALT less than or equal to 2x normal limits, serum creatinine less than or equal
to 1.5x normal

- ECOG Performance Status less than or equal to 1 (at planned time of transplantation)

- Patients with no active infection

Exclusion Criteria:

- Patients who have not recovered sufficiently from the side effects of the autologous
transplant (i.e. have > grade 2 toxicity in any organ system)

- Patients who have insufficient engraftment parameters according to the following
criteria: WBC < 2,500 /mm3 and platelets < 50,000/mm3

- Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell
infusion and lasting 2 weeks after NK-cell infusion.

- Intrinsic impaired organ function (as stated above).

- Physical or psychiatric conditions that in the estimation of the PI or designee place
the patient at high-risk of toxicity or non-compliance.

- Uncontrolled, life-threatening infections at the time of infusion.

- Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.

Type of Study:


Study Design:

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

Outcome Measure:

An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety.

Outcome Time Frame:

58 days post infusion of allogeneic NK-cells

Safety Issue:


Principal Investigator

Hans Klingemann, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center


United States: Food and Drug Administration

Study ID:

Allogeneic NKCell post ABMT



Start Date:

April 2006

Completion Date:

June 2012

Related Keywords:

  • Lymphoma
  • Myeloma
  • Leukemia
  • Natural killer cells
  • autologous stem cell transplant
  • immunotherapy
  • Leukemia
  • Lymphoma
  • Hematologic Neoplasms



Tufts Medical Center Boston, Massachusetts  02111