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

A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00943293

Enrollment

Registered

2009-07-22

Start date

2003-05-31

Completion date

2012-01-31

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

GVHD

Brief 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).

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* Clinical progression. * Contra-indications for vaccination.

Design outcomes

Primary

Measure	Time frame
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.	5 years

Secondary

Measure	Time frame
To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026