NCT00167180 · REGISTRY CONDITION SEARCH

Post Transplant Donor Lymphocyte Infusion

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

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2019-07-30

The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with blood cancers.

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

Number of Patients Alive

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outcome · POSTED

Number of Patients Alive Without Disease

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outcome · POSTED

Number of Participants With Complete Remission

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outcome · POSTED

Number of Patients With Acute Graft-Versus-Host Disease

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outcome · POSTED

Number of Patients With Bone Marrow Aplasia

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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: * Patients (age \> or = 1 years) with a diagnosis of relapse after related or unrelated allogeneic stem cell transplantation for a hematological malignancy. * For CML, relapse will be defined as any cytogenetic evidence of a Philadelphia chromosome or persistence of BCR/ABL rearrangements by molecular testing on at least two measurements over a 6 month interval. If cytogenetics are normal and there is PCR evidence of a BCR/ABL fusion, patients will be eligible if they have evidence of a quantitative increase in CML measured either by quantitative PCR or by fluorescent in situ hybridization (FISH). * For non-CML, relapse will be defined based on disease specific morphologic criteria from a bone marrow biopsy and aspirate or recurrence of disease specific cytogenetics. For disease specific definition of relapse, see appendix 3. Relapse can be determined morphologically with less than 5 percent blasts if definitive relapse can be determined. Equivocal results for relapse should result in a repeated test after an appropriate time interval (suggested 1 month) to determine eligibility. Post-transplant lymphoproliferative diseases (often referred to as EBV-associated lymphomas) are NOT eligible for this protocol. * For Chronic Phase CML patients only * \- must have failed (no response in 3 months or incomplete response at 6 months) or refused treatment with Gleevec * \- if no prior DLI, CML patients will first have DLI- if relapse occurs after DLI, DLI with chemotherapy per this protocol will be offered * Patients must be within one year of identification of relapse or if beyond that time period, must have at least 10% donor DNA by RFLP or cytogenetics. * Same allogeneic donor (sibling or URD) used for transplantation is available for lymphocyte donation. * No severe organ damage (by laboratory or clinical assessment) as measured by: * \- blood creatinine ≤ 2.0 mg/dL * \- liver function tests \< 5 x normal * \- left ventricular ejection fraction \> 40% (testing required only if symptomatic or prior known impairment). * \- pulmonary functions \> 50% (testing required only if symptomatic or prior known impairment). Oxygen saturation (\>92%) can be used in child where PFT's cannot be obtained. * \- chest x-ray without evidence of active infection * Off prednisone and other immunosuppressive agents (given for any reason) for at least 3 days prior to DLI infusions. * Performance status ≥ 60% * Women must not be pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * Patient must given written informed consent indicating understanding of the nature of the treatment and its potential risks Exclusion Criteria: * Concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible. * Patients being treated for GVHD with prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD. * Active CNS leukemia * Active fungal infection or pulmonary infiltrates (stable prior treated disease is allowable) * HIV positive
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 1 Year
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients with Chronic Myelogenous Leukemia (CML) who have failed or refused Gleevec(TM) therapy and will receive Donor Lymphocyte Infusion.
intervention Names
Procedure: Donor Lymphocyte Infusion
label
CML
type
ACTIVE_COMPARATOR
description
Patients with non-CML or CML who have failed Donor Lymphocyte Infusion (DLI) and will receive induction chemotherapy plus DLI.
intervention Names
Procedure: Donor Lymphocyte Infusion
Drug: Induction Chemotherapy
label
Non-CML or CML that Relapsed after Donor Lymphocyte Infusion
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
CML
Non-CML or CML that Relapsed after Donor Lymphocyte Infusion
description
donor cells infused over 2 hrs at cell dose of 0.5 dx 10\^8 CD3+T-cells/kg
name
Donor Lymphocyte Infusion
other Names
DLI
type
PROCEDURE
arm Group Labels
Non-CML or CML that Relapsed after Donor Lymphocyte Infusion
description
Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV
name
Induction Chemotherapy
other Names
Fludara
Endoxan, Cytoxan, Neosar, Procytox, Revimmune, cytophosphane
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 57
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.
measure
Number of Patients Alive
time Frame
1 Year

secondary Outcomes

description
The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
measure
Number of Patients Alive Without Disease
time Frame
1 Year
description
In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.
measure
Number of Participants With Complete Remission
time Frame
one year
description
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
measure
Number of Patients With Acute Graft-Versus-Host Disease
time Frame
Day 100
description
Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells. In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat.
measure
Number of Patients With Bone Marrow Aplasia
time Frame
Day 100

Full study description

brief Summary: The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with blood cancers.
detailed Description: When cancer relapses after donor bone marrow transplantation, regular dose chemotherapy offers little hope of prolonged survival. However, there is evidence that lymphocytes can attack cancer cells. There is considerable evidence that this immune attack on cancer cells is associated with graft-versus-host disease. Although graft-versus-host disease can cause problems, this immune reaction may, in part, be the way that bone marrow transplantation cures cancer. In this study we hope that infusion of immune cells from the subject's bone marrow donor plus a chemotherapy regimen of cyclophosphamide and fludarabine will activate the subject's immune system to attack their cancer.

Source references

references

citation
Miller JS, Weisdorf DJ, Burns LJ, Slungaard A, Wagner JE, Verneris MR, Cooley S, Wangen R, Fautsch SK, Nicklow R, Defor T, Blazar BR. Lymphodepletion followed by donor lymphocyte infusion (DLI) causes significantly more acute graft-versus-host disease than DLI alone. Blood. 2007 Oct 1;110(7):2761-3. doi: 10.1182/blood-2007-05-090340. Epub 2007 Jun 19.
pmid
17579184
type
DERIVED

Source notices and limitations

Discovery and provenance

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NCT00167180
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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 string sha256
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source url
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Preserved source evidence · Not medical advice