---
title: Vaccine Therapy With or Without Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Multiple Myeloma Undergoing Donor Stem Cell Transplant
nct_id: NCT00469820
overall_status: TERMINATED
phase: PHASE1
sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
study_type: INTERVENTIONAL
primary_condition: Leukemia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00469820.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00469820"
ct_last_update_post_date: 2014-03-21
last_seen_at: "2026-05-12T06:10:36.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Vaccine Therapy With or Without Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Multiple Myeloma Undergoing Donor Stem Cell Transplant

**Official Title:** Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant

**NCT ID:** [NCT00469820](https://clinicaltrials.gov/study/NCT00469820)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** low accrual
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1
- **Lead Sponsor:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- **Collaborators:** National Cancer Institute (NCI)
- **Conditions:** Leukemia, Multiple Myeloma and Plasma Cell Neoplasm
- **Start Date:** 2007-04
- **Completion Date:** 2010-03
- **CT.gov Last Update:** 2014-03-21

## Brief Summary

RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patient's brother or sister may kill any cancer cells that remain after transplant.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant.

## Detailed Description

OBJECTIVES:

* Determine time to relapse and overall survival of patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma treated with autologous tumor cell vaccine with or without donor lymphocyte infusion after HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation.
* Evaluate the safety and tolerability of this regimen in these patients.
* Determine the maximum tolerated dose of donor lymphocyte infusions in these patients.

OUTLINE: Patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation (HSCT). Patients then receive cancer cell vaccine with or without donor lymphocyte infusion. The donor lymphocytes are obtained from the same relative who donated stem cells for the HSCT.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of 1 of the following:

  * Acute myeloid leukemia (AML), meeting any of the following criteria:

    * Relapsed disease
    * AML arising from myelodysplastic syndromes
    * Primary refractory disease
    * De novo AML with high-risk features
  * Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:

    * De novo ALL that is Philadelphia chromosome positive or with t(4,11) cytogenetic features
    * Relapsed disease
  * Multiple myeloma (in need of treatment)
* Planning to undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
```

## Interventions

- **autologous tumor cell vaccine** (BIOLOGICAL)
- **peripheral blood lymphocyte therapy** (BIOLOGICAL)

## Primary Outcomes

- **Time to relapse**
- **Overall survival**
- **Safety and tolerability, in terms of incidence of graft-versus-host disease and local/systemic toxicities**
- **Maximum tolerated dose of donor lymphocytes**

## Locations (1)

- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sidney kimmel comprehensive cancer center at johns hopkins|baltimore|maryland|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00469820.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00469820*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*