NCT00891137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Apr 2009

Typical duration for phase_1 leukemia

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

5.2 years

First QC Date

April 30, 2009

Last Update Submit

October 23, 2014

Conditions

LeukemiaLymphomaMultiple MyelomaPlasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

adult acute myeloid leukemia 11q23 (MLL) abnormalitiesadult 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 leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesextranodal marginal zone B-cell lymphomamucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomastage I adult Burkitt lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomaWaldenstrom macroglobulinemianoncontiguous stage II adult immunoblasticcontiguous stage II adult immunoblasticlarge cell lymphomastage I adult immunoblastic large cell lymphomapreviously treated myelodysplastic syndromesrecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromessplenic marginal zone lymphomastage I multiple myelomastage II multiple myelomastage III multiple myelomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomarefractory anemia with excess blasts in transformationrefractory anemia with excess blastsrefractory anemiaprolymphocytic leukemiacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomarefractory chronic lymphocytic leukemiastage IV adult Burkitt lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomarecurrent childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomastage I mantle cell lymphomastage I adult lymphoblastic lymphomastage I adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomarecurrent childhood large cell lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomachildhood myelodysplastic syndromesBurkitt lymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    100 days post transplant

Secondary Outcomes (5)

  • Neutrophil and platelet recovery

    100 days post transplant

  • Persistence of CLT-008 derived cells

    100 days post transplant

  • Graft-versus-host disease (GVHD)

    100 days post transplant

  • Non-relapse mortality

    100 days post transplant

  • Infections

    42 days post transplant

Study Arms (4)

Group A

EXPERIMENTAL

Low dose, single donor CLT-008 (human myeloid progenitor cells)

Biological: human myeloid progenitor cells

Group B

EXPERIMENTAL

Low dose, multiple donor CLT-008 (human myeloid progenitor cells)

Biological: human myeloid progenitor cells

Group C

EXPERIMENTAL

Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)

Biological: human myeloid progenitor cells

Group D

EXPERIMENTAL

High dose, multiple donor CLT-008 (human myeloid progenitor cells)

Biological: human myeloid progenitor cells

Interventions

human myeloid progenitor cellsBIOLOGICAL

Single intravenous injection/infusion

Also known as: CLT-008, hMPC
Group AGroup BGroup CGroup D

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Symptomatic underlying pulmonary disease or requiring oxygen
  • Active infection
  • HIV positive
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Loyola University Medical Center, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

Location

University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseBlast CrisisLymphoma, Large B-Cell, DiffuseLeukemia, Myeloid, Chronic-PhaseLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaWaldenstrom MacroglobulinemiaDendritic Cell Sarcoma, InterdigitatingLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellAnemia, Refractory, with Excess of BlastsAnemia, RefractoryLeukemia, ProlymphocyticLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLeukemia, LymphoidLeukemia, B-CellAnemia

Study Officials

  • John E Wagner, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

US(8)