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TerminatedNCT00943293Updated Mar 17, 2014

Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies

A Phase 1 interventional study of Fludarabine and Melphalan in Preleukemia, Myeloproliferative Disorders and Lymphoma, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-17.

Sponsored by University of Chicago · Phase 1, Interventional, and Treatment

Why this study was terminated
Poor accrual; did not enter phase 2
Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).

02

Conditions studied

  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma
  • Myeloma
  • Graft Versus Host Disease

Keywords

  • GVHD
03

In context

Hematologic Neoplasms

1,463 studies on the registry are indexed under Hematologic Neoplasms; 432 are open to participants now.

This study's enrollment of 1 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Relapsed or refractory acute myelogenous or lymphoid leukemia.
  • Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
  • Chronic myelogenous leukemia in accelerated phase or blast-crisis.
  • Chronic myelogenous leukemia in second or subsequent chronic phase
  • Recurrent or refractory malignant lymphoma or Hodgkin's disease
  • Multiple myeloma at high risk for disease recurrence.
  • Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
  • Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.

Exclusion criteria

Exclusion Criteria:

  • Clinical progression.
  • Contra-indications for vaccination.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Vaccine

    Drug: Fludarabine · Drug: Melphalan · Drug: Campath

Interventions

  • DrugFludarabine

    Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.

  • DrugMelphalan

    Melphalan 140 mg/m2 IV on day -2.

  • DrugCampath

    Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

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What researchers measure

Primary outcomes

  1. To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity.

    Time frame: 5 years

Secondary outcomes

  1. To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.

    Time frame: 5 years

07

Study locations

1 site
  • The Uniiversity of Chicago
    Chicago, Illinois 60637, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00943293
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Jul 22, 2009
Start date
May 2003
Primary completion
Sep 2011
Completion
Jan 2012
Last update
Mar 17, 2014

Study contacts

Andrew Artz, M.D.
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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