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A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia

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Trial Information

A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia


Key

Inclusion Criteria:



- Hematological malignancy, including:

- AML, ALL or MDS

- Planned treatment with cytarabine-based chemotherapy regimen

- Adequate hepatic, renal, hematologic, cardiac and respiratory function

Key Exclusion Criteria:

- Prior allograft or history of active GVHD within 3 years

- Pregnant or nursing

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Incidence of serious adverse reactions

Outcome Time Frame:

Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CLT008-02

NCT ID:

NCT01297543

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplasia
  • Induction chemotherapy
  • Re-induction chemotherapy
  • Consolidation chemotherapy
  • Leukemia
  • Myelodysplasia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of MinnesotaMinneapolis, Minnesota  55455
Cleveland ClinicCleveland, Ohio  44195
The Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Stanford Hospital and ClinicsStanford, California  94305
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Loyola University Medical Center, Cardinal Bernardin Cancer CenterMaywood, Illinois  60153
Case Western Reserve University, University Hospitals of ClevelandCleveland, Ohio  44106
University of California San Francisco Medical CenterSan Francisco, California  94143
Indiana Blood and Marrow Transplantation, LLCBeech Grove, Indiana  46107