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A Phase I Trial to Determine Safety and Tolerability of Ex Vivo Expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies


Phase 1
12 Years
65 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm, Myelodysplastic Syndromes

Thank you

Trial Information

A Phase I Trial to Determine Safety and Tolerability of Ex Vivo Expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies


Key

Inclusion Criteria:



- Undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x
10e7 cells/kg for hematological malignancy:

- High risk acute myeloid leukemia (AML) in complete remission

- Very high risk pediatric AML; patients <21 years eligible with <25% blasts in
marrow after failed chemotherapy

- High risk acute lymphocytic leukemia (ALL) in complete remission

- Chronic myelogenous leukemia (CML), excluding refractory blast crisis

- Myelodysplasia (MDS) IPPS Int-2 or high risk, or refractory anemia with severe
pancytopenia or high risk cytogenetics

- Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal
zone B-cell lymphoma or follicular lymphoma that have progressed after two prior
therapies

- Lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after
initial therapy and complete or partial remission

- Large cell non-Hodgkin lymphoma (NHL) in second complete or partial remission
(chemotherapy refractory large cell NHL not eligible)

- Lymphoblastic lymphoma, peripheral T cell lymphoma including angioimmunoblastic
lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if
stage III/IV in complete or partial remission, or after progression if stage
I/II <1 year (chemotherapy refractory high-grade NHL not eligible)

- Multiple myeloma beyond 2nd partial remission

- Preparative regimen consisting of cyclophosphamide, fludarabine, and total body
irradiation

- Adequate organ function

Key Exclusion Criteria:

- Symptomatic underlying pulmonary disease or requiring oxygen

- Active infection

- HIV positive

- 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:

Safety and tolerability

Outcome Time Frame:

100 days post transplant

Safety Issue:

Yes

Principal Investigator

John E Wagner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute

Authority:

United States: Food and Drug Administration

Study ID:

MT 2008-38

NCT ID:

NCT00891137

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • adult acute myeloid leukemia 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia inv(16)(p13;q22)
  • adult acute myeloid leukemia t(15;17)(q22;q12)
  • adult acute myeloid leukemia t(16;16)(p13;q22)
  • adult acute myeloid leukemia t(8;21)(q22;q22)
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • chronic phase chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • extranodal marginal zone B-cell lymphoma
  • mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • stage I adult Burkitt lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • Waldenstrom macroglobulinemia
  • noncontiguous stage II adult immunoblastic
  • contiguous stage II adult immunoblastic
  • large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • previously treated myelodysplastic syndromes
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • refractory anemia
  • prolymphocytic leukemia
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • refractory chronic lymphocytic leukemia
  • stage IV adult Burkitt lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • stage I mantle cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • recurrent childhood large cell lymphoma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • childhood myelodysplastic syndromes
  • Burkitt lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, Non-Hodgkin
  • Hematologic Neoplasms

Name

Location

Children's Hospital of Orange CountyOrange, California  92668
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
University of California, San DiegoLa Jolla, California  92037-1709
Loyola University Medical Center, Cardinal Bernardin Cancer CenterMaywood, Illinois  60153
Case Western Reserve University, University Hospitals of ClevelandCleveland, Ohio  44106
University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical CenterMinneapolis, Minnesota  55455
Cleveland Clinic, Taussig Cancer InstituteCleveland, Ohio  44195