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Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy

Primary Purpose

Leukemia, Lymphoma, Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
human myeloid progenitor cells
Sponsored by
Cellerant Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring 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

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Orange County
  • Alfred I. duPont Hospital for Children
  • Children's National Medical Center
  • Loyola University Medical Center, Cardinal Bernardin Cancer Center
  • University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
  • Cleveland Clinic, Taussig Cancer Institute
  • Nationwide Children's Hospital
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

Neutrophil and platelet recovery
Persistence of CLT-008 derived cells
Graft-versus-host disease (GVHD)
Non-relapse mortality
Infections

Full Information

First Posted
April 30, 2009
Last Updated
October 23, 2014
Sponsor
Cellerant Therapeutics
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT00891137
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellerant Therapeutics
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Low dose, single donor CLT-008 (human myeloid progenitor cells)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
Arm Title
Group C
Arm Type
Experimental
Arm Description
Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)
Arm Title
Group D
Arm Type
Experimental
Arm Description
High dose, multiple donor CLT-008 (human myeloid progenitor cells)
Intervention Type
Biological
Intervention Name(s)
human myeloid progenitor cells
Other Intervention Name(s)
CLT-008, hMPC
Intervention Description
Single intravenous injection/infusion
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
100 days post transplant
Secondary Outcome Measure Information:
Title
Neutrophil and platelet recovery
Time Frame
100 days post transplant
Title
Persistence of CLT-008 derived cells
Time Frame
100 days post transplant
Title
Graft-versus-host disease (GVHD)
Time Frame
100 days post transplant
Title
Non-relapse mortality
Time Frame
100 days post transplant
Title
Infections
Time Frame
42 days post transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E Wagner, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Loyola University Medical Center, Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cleveland Clinic, Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cellerant.com
Description
Cellerant Therapeutics, Inc.

Learn more about this trial

Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy

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