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A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplasia, Chronic Myeloid Leukemia

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Trial Information

A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies


Inclusion Criteria:



- Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid
leukemia (AML) with one or more of the following criteria

- CR 1 with poor risk features

- CR 2, or higher order CR

- Acute lymphoblastic leukemia (ALL) with one of the following criteria

- CR 1 with poor risk features

- CR 2, or higher order CR

- Myelodysplasia, RAEB I

- Donor has been identified

- Age ≤ 65 years.

- Performance Status 0-1.

Exclusion Criteria:

- Patients relapsing <6 months after autologous SCT are not eligible.

- Patients with active infections requiring oral or intravenous antibiotics are not
eligible for enrollment until resolution of infection.

- Non-pregnant and non-nursing

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable.

Outcome Time Frame:

thru 6 months after transplant

Safety Issue:

No

Principal Investigator

Sherif Farag, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

0704-19 IUCRO-0184

NCT ID:

NCT00593554

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplasia
  • Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265