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Reduced Intensity Haploidentical Transplantation With NK Cell Infusion for Pediatric Acute Leukemia and High Risk Solid Tumors, BMT06407


Phase 1/Phase 2
6 Months
25 Years
Open (Enrolling)
Both
Leukemia, Solid Tumors

Thank you

Trial Information

Reduced Intensity Haploidentical Transplantation With NK Cell Infusion for Pediatric Acute Leukemia and High Risk Solid Tumors, BMT06407


Inclusion Criteria:



- Solid tumors that have failed auto transplant or are ineligible to receive auto
transplant

- Relapsed AML in 1st relapse or 2nd or 3rd CR

- Relapsed ALL if they fail to attain an initial remission or if they relapse within 1
year following the discontinuation of chemotherapy.

- Greater than or equal to 6 months and <26 years old

- Suitable haploidentical donor available

Exclusion Criteria:

- Leukemia with >25% blasts in bone marrow at the time of admission to the HSCT unit.

- Serum bilirubin >3 mg/dl

- GFR <40 ml/min/1.73 mw

- Cardiac left ventricular ejection fraction <40%

- HIV+

- Pregnant

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade III or IV GVHD

Outcome Time Frame:

Day 100

Safety Issue:

Yes

Principal Investigator

Kenneth DeSantes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

BMT06407

NCT ID:

NCT00582816

Start Date:

August 2008

Completion Date:

February 2016

Related Keywords:

  • Leukemia
  • Solid Tumors
  • Recurrent or Refractory Leukemia or Solid Tumors in Pediatrics
  • Leukemia
  • Neoplasms

Name

Location
Kenneth DeSantes., MD Madison, Wisconsin  53972