NCT00891592

Brief Summary

This protocol will enroll subjects with advanced hematologic malignancies who do not have a suitable related or unrelated donor to undergo a Stem Cell Transplant. In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent to a laboratory in order to grow the T cells (from the cord blood) and increase the activity of the cord blood T cells. The purpose of this part of the study is to see if it is safe to give study subjects activated T cells made from a small portion of their donor UCB unit immediately after the UCB transplant. Activated T cells have been used safely in stem cell transplantation studies in the past, but they have never been studied UCB transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

April 29, 2009

Last Update Submit

August 17, 2016

Conditions

CMLAMLMDSALLNHLMultiple MyelomaHodgkin's Disease

Keywords

AMLMDSALLNHLMultiple MyelomaHodgkin's

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion.

    90 Days post Transplant

Study Arms (2)

Dose Escalation Arm

EXPERIMENTAL

Subjects with cord blood stored in more than one fraction will be enrolled into Dose Escalation Arm. Subjects will receive Cord Blood Stem Cell Transplant followed by expanded Cord Blood T cells on Day 0.

Biological: Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells

Observation Arm

ACTIVE COMPARATOR

Subjects with cord blood stored in one fraction will be enrolled into the Observation Arm. Subjects will receive Cord Blood Stem Cell Transplant on Day 0.

Other: Observation Arm

Interventions

Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cellsBIOLOGICAL

Single infusion of Cord Blood Cells AND Single Infusion of ex vivo CD3/CD28 costimulated Umbilical Cord Blood T cells. Table 6: Dose escalation (Dose level CD3+ cell dose) * 1xE5 cells/kg * 2xE6 cells/kg * 3xE7 cells/kg * 4xE8 cells/kg

Dose Escalation Arm
Observation ArmOTHER

Single infusion of Cord Blood Cells

Observation Arm

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Relapsed or persistent advanced hematologic malignancy; incurable with standard chemotherapy and eligible for allogeneic HSCT, including:
  • CHRONIC MYELOGENOUS LEUKEMIA (CML). Subjects in accelerated or blast phase or subjects in chronic phase with inadequate response to Imatinib or intolerant to Imatinib.
  • ACUTE MYELOGENOUS LEUKEMIA (AML). Subject with high risk disease in first complete remission (CR). High risk disease includes the following cytogenetic abnormalities: monosomy 7, deletion 5, trisomy 8, inversion 3, t(3;3), t(6;9), or t(6;11). Subjects with complex cytogenetic abnormalities (more than 3 chromosomal abnormalities).
  • ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with diagnosis of AML after receiving chemotherapy, radiation therapy or biopsy showing myelodysplastic syndrome.
  • ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with persistent AML after 2 cycles of standard induction chemotherapy.
  • ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects in first complete remission.
  • MYELODYSPLASTIC SYNDROME (MDS). Subjects with intermediate or high risk disease based upon International Prognostic Scoring System.
  • ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with Philadelphia Chromosome (have t(9;22) cytogenetic abnormality) or molecular documentation for BCR-ABL translocation.
  • ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with primary refractory disease or subjects in 1st complete remission.
  • NHL or HODKIN'S DISEASE. Subjects who relapse following autologous Stem Cell Transplant.
  • INDOLENT NHL. Subjects with progressive disease following \> 2 regimens.
  • MULTIPLE MYELOMA. Subjects who relapse following following autologous Stem Cell Transplant.
  • Adults age 21-50.
  • Expected survival 4 weeks.
  • Subjects with no suitable related or unrelated donor for Stem Cell Transplant.
  • +3 more criteria

You may not qualify if:

  • Subject is pregnant or lactating.
  • Subject has an uncontrolled infection.
  • Subject has an active or untreated disease involving the central nervous system.
  • Subject has an active or uncontrolled medical condition that would preclude participation in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Hexner EO, Luger SM, Reshef R, Jeschke GR, Mangan JK, Frey NV, Frank DM, Richman LP, Vonderheide RH, Aqui NA, Rosenbach M, Zhang Y, Chew A, Loren AW, Stadtmauer EA, Levine BL, June CH, Emerson SG, Porter DL. Infusion of CD3/CD28 costimulated umbilical cord blood T cells at the time of single umbilical cord blood transplantation may enhance engraftment. Am J Hematol. 2016 May;91(5):453-60. doi: 10.1002/ajh.24303. Epub 2016 Apr 4.

    PMID: 26858124DERIVED

Related Links

MeSH Terms

Conditions

Multiple MyelomaHodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphomaLymphatic Diseases

Study Officials

  • David Porter, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Elizabeth Hexner, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

May 1, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2011

Study Completion

May 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)