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Transplantation of Hematopoetic Stem Cells and Infusion of CD56+CD3- NK Cells From Haploidentical Donors for Patients With Hematological Malignancies


Phase 1/Phase 2
18 Years
54 Years
Open (Enrolling)
Both
Acute Myeloid Leukemias, Advanced Hematological Malignancies, Indication for Allogeneic Stem Cell Transplantation, no HLA-identical Donor Available

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Trial Information

Transplantation of Hematopoetic Stem Cells and Infusion of CD56+CD3- NK Cells From Haploidentical Donors for Patients With Hematological Malignancies


Inclusion Criteria:



- Patients with AML or ALL in first CR with the following high risk features:

1. AML with aberration Del (5q) -5, del (7q) -7, t(9;22) or t(6;9), abn 3q, 9q,
11q, 20q, 21q, 17p;

2. AML with a complex caryotype;

3. secondary AML after previous chemo- or radiotherapy or MDS;

4. Ph-positive ALL

- Patients with AML or ALL after induction failure or in second CR

- Patients with CML in second chronic or accelerated phase

- Patients with malignant Lymphoma and the following high risk features:

1. relapse after autologous transplantation

2. primary chemotherapy refractory disease

- All patients must fulfill the following criteria:

1. lack of a suitable HLA-identical family, unrelated or cord blood donor

2. no active infection, no severe impairment of cardial, pulmonary, renal and
hepatic function

3. blast count in the marrow < 30%

4. informed consent

Exclusion Criteria:

- active infection, no severe impairment of cardial, pulmonary, renal and hepatic
function

- blast count in the marrow > 30%

- unable or unwilling to sign and/or understand informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate feasibility and safety of alloreactive CD56+/CD3- donor NK cells after one haplotype mismatched transplantation

Outcome Description:

To evaluate feasibility and safety of cellular immunotherapy with purified alloreactive CD56+/CD3- donor NK cells after one haplotype mismatched hematopoietic stem cell transplantation in patients with high risk hematological malignancies who lack an HLA-identical donor.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Lutz Uharel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University Medicine

Authority:

Germany: State Office of Health and Social Affairs

Study ID:

BELEHAPLO-1412001

NCT ID:

NCT01220544

Start Date:

July 2001

Completion Date:

October 2011

Related Keywords:

  • Acute Myeloid Leukemias
  • Advanced Hematological Malignancies
  • Indication for Allogeneic Stem Cell Transplantation
  • no HLA-identical Donor Available
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Hematologic Neoplasms

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