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A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma, Myeloma

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Trial Information

A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies


Inclusion Criteria:



Phase I portion:

- Relapsed or refractory acute myelogenous or lymphoid leukemia.

- Chronic myelogenous leukemia in accelerated phase or blast-crisis.

- Recurrent or refractory malignant lymphoma or Hodgkin's disease

- Recurrent or refractory multiple myeloma.

- Chronic lymphocytic leukemia, relapsed or with poor prognostic features.

- Myeloproliferative disorder (polycythemia vera, myelofibrosis) with
transformation

- Myelodysplastic syndromes with more than 5% blasts.

Phase II portion:

- AML with active disease or beyond CR2.

- MDS with more than 5% blasts.

Exclusion Criteria:

- Clinical progression. Such patients may be treated on other treatment protocols or at
the investigator's discretion. Such patients will continue to be monitored for
survival and, may be asked to continue to provide specimens for studies of minimal
residual disease and immune reconstitution as other treatments are recommended.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Andrew Artz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

12-0132

NCT ID:

NCT00943319

Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myeloma
  • Cancers of the blood
  • Leukemia
  • Lymphoma
  • Hematologic Neoplasms

Name

Location

The University of ChicagoChicago, Illinois  60637