NCT00068718

Brief Summary

This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed (disease that has returned), or progressing cancer after donor hematopoietic cell transplantation. White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back (recurrent) after a donor hematopoietic cell transplant.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2003

Longer than P75 for phase_1

Geographic Reach
3 countries

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

9.9 years

First QC Date

September 10, 2003

Results QC Date

January 20, 2017

Last Update Submit

January 15, 2020

Conditions

Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Hodgkin LymphomaRecurrent Non-Hodgkin LymphomaRecurrent Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

  • Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD

    Percentage of Participants with Grade IV Acute GVHD

    100 days after DLI

Secondary Outcomes (6)

  • Incidence of Graft Rejection

    100 days after DLI

  • Incidence of Relapse/Progression

    1 year after DLI

  • Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant

    100 days after DLI

  • Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant

    100 days after DLI

  • Overall Survival

    1 year after DLI

  • +1 more secondary outcomes

Study Arms (1)

Treatment (DLI)

EXPERIMENTAL

Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.

Biological: Therapeutic Allogeneic Lymphocytes

Interventions

Therapeutic Allogeneic LymphocytesBIOLOGICAL

Given IV

Also known as: Allogeneic Lymphocytes
Treatment (DLI)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Only patients having received a preceding nonmyeloablative allogeneic transplantation with fludarabine/2 Gy total-body irradiation (TBI) - 4 Gy TBI or 2 Gy TBI - 4 Gy TBI conditioning from either a related or unrelated donor are eligible for this protocol
  • Patients with persistent, relapsed or progressing malignancy after nonmyeloablative allogeneic transplantation; persistent disease will be defined as a failure to achieve a response as compared to baseline
  • Patients must be able to tolerate a taper of systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day; all other immunosuppressive therapy must have been discontinued for at least two weeks without significant flares in GVHD (i.e., increase of acute GVHD by one or more grades)
  • Patients must have persistent donor cluster of differentiation (CD)3 cells (\> 5% donor CD3 cells by a deoxyribonucleic acid \[DNA\]-based assay that compares the profile of amplified fragment length polymorphisms \[ampFLP\] \[or fluorescent in situ hybridization (FISH) studies or variable number tandem repeat (VNTR)\])
  • DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with granulocyte colony-stimulating factor (G-CSF) or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the DLI product must be from the original donor of hematopoietic cell transplantation
  • DONOR: Original donor of hematopoietic cell transplantation
  • DONOR: Donor must give consent to leukapheresis
  • DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
  • DONOR: Donor must be medically fit to undergo the apheresis procedure (institutional guidelines for apheresis)

You may not qualify if:

  • Current grade II to IV acute GVHD or extensive chronic GVHD
  • Karnofsky score \< 50%
  • Lansky Play-Performance Score \< 40 for pediatric patients
  • DONOR: Donors who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the American Association of Blood Banks (AABB)
  • DONOR: Pregnancy
  • DONOR: Human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection
  • DONOR: Recent immunization may require a delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Puget Sound Health Care System

Seattle, Washington, 98101, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Universitaet Leipzig

Leipzig, D-04103, Germany

Location

University of Torino

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Blast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteHodgkin DiseaseLymphoma, Non-HodgkinMultiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Results Point of Contact

Title
Dr. Brenda M. Sandmaier
Organization
Fred Hutchinson Cancer Research Center
bsandmai@fhcrc.org
(206) 667-4961

Study Officials

  • Brenda Sandmaier

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

May 1, 2003

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 31, 2020

Results First Posted

March 10, 2017

Record last verified: 2020-01

Locations

US(2)DE(1)IT(1)