Clinical trial NCT00891137: Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Lymphoma
Multiple Myeloma
Plasma Cell Neoplasm
Myelodysplastic Syndromes
Keywords: 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
Lead sponsor: Cellerant Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2009-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic cancer. In this study, the safety and tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will be determined by monitoring for adverse reactions, neutrophil and platelet recovery, hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability
timeFrame: 100 days post transplant
Secondary outcomes:
measure: Neutrophil and platelet recovery
timeFrame: 100 days post transplant
measure: Persistence of CLT-008 derived cells
timeFrame: 100 days post transplant
measure: Graft-versus-host disease (GVHD)
timeFrame: 100 days post transplant
measure: Non-relapse mortality
timeFrame: 100 days post transplant
measure: Infections
timeFrame: 42 days post transplant
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Maywood
country: United States
facility: Loyola University Medical Center, Cardinal Bernardin Cancer Center
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic, Taussig Cancer Institute
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Minnesota
name: John E Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: