Vaccine Therapy With or Without Donor Lymphocyte Infusion... | NCT00469820

Studies
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

NCT00469820

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Terminated

Last Update Posted

Mar 21, 2014Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Leukemia
Multiple Myeloma and Plasma Cell Neoplasm

Interventions

autologous tumor cell vaccine
peripheral blood lymphocyte therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Link
P01CA015396	U.S. NIH Grant/Contract	View source
P30CA006973	U.S. NIH Grant/Contract	View source
JHOC-J06118

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low accrual

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 3, 2007

First Submission Date that Met QC Criteria

May 3, 2007

First Posted Date

May 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2014

Last Update Posted Date

Mar 21, 2014Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

Conditions

Leukemia
Multiple Myeloma and Plasma Cell Neoplasm

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult 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 leukemia
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
stage III multiple myeloma
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
stage I multiple myeloma
stage II multiple myeloma
refractory multiple myeloma

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol A. Huff, MD	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins		Baltimore	Maryland	21231-2410	United States

ID	Term
D007938	Leukemia
D009101	Multiple Myeloma
D054219	Neoplasms, Plasma Cell
D000013	Congenital Abnormalities
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007945	Leukemia, Lymphoid
D008206	Lymphatic Diseases
D007951	Leukemia, Myeloid

Name	Type	Description	Arm Group Labels	Other Names
autologous tumor cell vaccine	Biological
peripheral blood lymphocyte therapy	Biological