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
12 Years
65 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm, Myelodysplastic Syndromes
Both
Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm, Myelodysplastic Syndromes
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 County | Orange, California 92668 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| University of California, San Diego | La Jolla, California 92037-1709 |
| Loyola University Medical Center, Cardinal Bernardin Cancer Center | Maywood, Illinois 60153 |
| Case Western Reserve University, University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center | Minneapolis, Minnesota 55455 |
| Cleveland Clinic, Taussig Cancer Institute | Cleveland, Ohio 44195 |
