NCT00068718 · REGISTRY CONDITION SEARCH

Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2020-01-31

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Incidence of Graft Rejection

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outcome · POSTED

Incidence of Relapse/Progression

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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 with rapidly progressing malignancies (acute myeloid leukemia \[AML\], acute lymphocytic leukemia \[ALL\], blastic phase chronic myelogenous leukemia \[CML-BC\] intermediate-high-grade non-Hodgkin lymphoma \[NHL\], Hodgkin's lymphoma or aggressive multiple myeloma \[MM\]) should receive salvage chemotherapy or radiation before DLI according to the recommendation made in this protocol; any form of salvage chemotherapy should be discontinued no less than 3 weeks before DLI; therapy with Gleevec or interferon (IFN)-alpha should be discontinued prior to DLI; after salvage chemotherapy restaging is performed, patients with progressive disease and patients not meeting the inclusion criteria of the study after chemotherapy will be excluded from the study; patients are allowed to receive further doses of chemotherapy after DLI administration if they are scheduled for further DLI; after additional therapy the patients must be restaged and must again meet inclusion criteria to receive further DLI * 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) Exclusion Criteria: * 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
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: Therapeutic Allogeneic Lymphocytes
label
Treatment (DLI)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (DLI)
description
Given IV
name
Therapeutic Allogeneic Lymphocytes
other Names
Allogeneic Lymphocytes
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 35
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Percentage of Participants with Grade IV Acute GVHD
measure
Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD
time Frame
100 days after DLI

secondary Outcomes

description
Percentage patients with graft rejection.
measure
Incidence of Graft Rejection
time Frame
100 days after DLI
description
CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
measure
Incidence of Relapse/Progression
time Frame
1 year after DLI
description
Percentage of Participants with II-IV Acute GVHD
measure
Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant
time Frame
100 days after DLI
description
Percentage of Participants with infections.
measure
Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant
time Frame
100 days after DLI
description
Percentage patients surviving 1 year post-transplant.
measure
Overall Survival
time Frame
1 year after DLI
description
Percentage of patients with progression-free survival
measure
Progression-free Survival
time Frame
1 year after DLI

Full study description

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.
detailed Description: PRIMARY OBJECTIVES: I. To assess the safety of donor lymphocyte infusion (DLI) as adoptive immunotherapy for persistent or relapsed malignant diseases in patients after related or unrelated nonmyeloablative transplantation. SECONDARY OBJECTIVES: I. To determine disease response, progression free and overall survival, chimerism, grade of graft-versus-host disease (GVHD), and infections. OUTLINE: 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. After completion of study treatment, patients are followed up periodically.

Source references

Source notices and limitations

Discovery and provenance

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exact text
NCT00068718
start
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offset unit
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query cond
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice