NCT00558675

Brief Summary

The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2010

Typical duration 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

First Submitted

Initial submission to the registry

November 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
3 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 22, 2020

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

November 13, 2007

Last Update Submit

January 17, 2020

Conditions

Hematological MalignancyLeukemiaLymphomaMultiple Myeloma

Keywords

Non-Hodgkins LymphomaHodgkins LymphomaAcute Lymphoblastic LeukemiaChronic Myeloid LeukemiaChronic Lymphocytic LeukemiaMultiple MyelomaImmunotherapyAllogeneic Cell Therapy

Outcome Measures

Primary Outcomes (1)

  • Determination of toxicity related to AlloStim infusion in accordance with NCI Common Toxicity Criteria v.3

    Within first 48 hours post infusion, at 30 days and at 60 days post infusion

Secondary Outcomes (2)

  • Evaluation and reporting of anti-tumor response will be conducted in accordance with internationally accepted criteria for the disease indication being evaluated

    30 days and 60 days post infusion and yearly thereafter

  • Immunological Response

    30 days, 60 days

Study Arms (4)

1

EXPERIMENTAL

Single intravenous infusion of AlloStim

Biological: AlloStim

2

EXPERIMENTAL

Intravenous AlloStim infusion on day 1 and day 7

Biological: AlloStim

3

EXPERIMENTAL

Intravenous AlloStim infusion on day 1, day 7 and day 14

Biological: AlloStim

4

EXPERIMENTAL

Intravenous AlloStim infusion on day 1, day 7, day 14 and day 21

Biological: AlloStim

Interventions

AlloStimBIOLOGICAL

single intravenous infusion of 1 x 10\^9 AlloStim cells

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed hematological malignancy
  • unresponsive to chemotherapy and/or recurrence after autologous transplant
  • adequate kidney, liver, lung and heart function

You may not qualify if:

  • prior allogeneic transplant
  • immunosuppressive therapy for concurrent medical condition
  • active viral infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah-Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (3)

  • Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.

    PMID: 18054441BACKGROUND

  • Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.

    PMID: 18565579BACKGROUND

  • Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.

    PMID: 18834631BACKGROUND

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemiaLymphomaMultiple MyelomaLymphoma, Non-HodgkinHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, LymphoidLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-Cell

Study Officials

  • Dr. Michael Har-Noy

    Immunovative Therapies

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 15, 2007

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

January 22, 2020

Record last verified: 2012-11

Locations

IL(1)