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

NCT ID: NCT00943293

Last Updated: 2014-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2012-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Preleukemia Myeloproliferative Disorders Lymphoma Myeloma Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaccine

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

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

Melphalan

Intervention Type DRUG

Melphalan 140 mg/m2 IV on day -2.

Campath

Intervention Type DRUG

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

Interventions

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Fludarabine

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

Intervention Type DRUG

Melphalan

Melphalan 140 mg/m2 IV on day -2.

Intervention Type DRUG

Campath

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Artz, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The Uniiversity of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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12175A

Identifier Type: -

Identifier Source: org_study_id

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