Clinical trial · Interventional

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

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

NCT00891137CI-TRIAL-00015911completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Plasma Cell Neoplasm	Plasma Cell Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
human myeloid progenitor cells	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Group A
description
Low dose, single donor CLT-008 (human myeloid progenitor cells)
interventionNames
1. Biological: human myeloid progenitor cells
type
EXPERIMENTAL
label
Group B
description
Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
interventionNames
1. Biological: human myeloid progenitor cells
type
EXPERIMENTAL
label
Group C
description
Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 12 Years
Maximum age: 65 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment