LeukemiaPhase 1NCT00891137

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

A Phase 1 study testing human myeloid progenitor cells in people with Leukemia and Lymphoma, run by Cellerant Therapeutics at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Leukemia, Lymphoma, Multiple Myeloma
What is being tested?: human myeloid progenitor cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 8 sitesUnited States
Study dates: Apr 2009to Jun 2014
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
Minneapolis, Minnesota, 55455
Children's Hospital of Orange County
Orange, California, 92868
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803

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About this study

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

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.

Conditions: Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm, Myelodysplastic Syndromes
Being tested: human myeloid progenitor cells
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
Medical subject headings: Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Congenital Abnormalities, Leukemia, Myeloid, Accelerated Phase, Blast Crisis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

human myeloid progenitor cellsBiological
Also called CLT-008, hMPC
Single intravenous injection/infusion

Study groups in NCT00891137
Study group	Role	What they receive
Group A	Experimental	Low dose, single donor CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells
Group B	Experimental	Low dose, multiple donor CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells
Group C	Experimental	Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells
Group D	Experimental	High dose, multiple donor CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability
Measured: 100 days post transplant

Secondary outcomes (5)

Neutrophil and platelet recovery
Measured: 100 days post transplant
Persistence of CLT-008 derived cells
Measured: 100 days post transplant
Graft-versus-host disease (GVHD)
Measured: 100 days post transplant
Non-relapse mortality
Measured: 100 days post transplant
Infections
Measured: 42 days post transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2014

First posted1 May 2009 (estimated)
Study startApr 2009
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00891137
Sponsor's protocol ID: MT 2008-38
Status last verified: Oct 2014
First submitted: 30 Apr 2009
Last updated: 27 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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