NCT00469820

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.

Trial Health

57
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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2.9 years

First QC Date

May 3, 2007

Last Update Submit

March 20, 2014

Conditions

LeukemiaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiasecondary acute myeloid leukemiastage III multiple myelomauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiastage I multiple myelomastage II multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

autologous tumor cell vaccineBIOLOGICAL
peripheral blood lymphocyte therapyBIOLOGICAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

LeukemiaMultiple MyelomaNeoplasms, Plasma CellCongenital AbnormalitiesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

FANG vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, LymphoidLymphatic DiseasesLeukemia, Myeloid

Study Officials

  • Carol A. Huff, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

US(1)