NCT00521261

Brief Summary

RATIONALE: Giving high doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Colony stimulating factors, such as aldesleukin and GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells that have been treated with antibodies after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells given together with low-dose aldesleukin and low-dose GM-CSF after donor stem cell transplant in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1 lymphoma

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

August 24, 2007

Last Update Submit

March 4, 2014

Conditions

Lymphoma

Keywords

recurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaWaldenstrom macroglobulinemiaadult nasal type extranodal NK/T-cell lymphomarecurrent adult grade III lymphomatoid granulomatosiscutaneous B-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (4)

  • Maximum tolerated dose

  • Time to relapse

  • Disease-free survival

  • Overall survival

Interventions

anti-CD3 x anti-CD20 bispecific antibody-armed activated T cellsBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed CD20-positive non-Hodgkin lymphoma * Relapsed, resistant, or chemorefractory disease * Must have an available HLA-identical sibling donor * No significant skin breakdown from tumor or other disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * DLCO ≥ 50% of normal * No symptomatic obstructive or restrictive pulmonary disease * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min * Direct bilirubin ≤ 2.0 mg/dL (even if attributable to disease) * SGOT and SGPT ≤ 2.5 times normal (even if attributable to disease) * No history of severe hepatic dysfunction * No severe cardiac dysfunction * LVEF ≥ 50% by gated blood pool scan * No major heart disease * Patients with congenital or acquired heart disease or cardiac arrhythmias must undergo a cardiology consultation and evaluation * No active infections * Patients who have not been seen and evaluated by a dentist for teeth cleaning and examination for potential sources of infection are ineligible * HIV antibody negative * No uncompensated major thyroid or adrenal dysfunction * Not pregnant or nursing * Persistently elevated systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg must be controlled with antihypertensive agents for at least 7 days prior to initiation of cell therapy * Patients with essential hypertension that is controlled with medication are eligible PRIOR CONCURRENT THERAPY: * Prior total dose of doxorubicin or daunorubicin must have been less than 450 mg/m\^2 unless an endomyocardial biopsy shows less than grade 2 drug effect * No concurrent nitroglycerin preparations for angina pectoris * No antiarrhythmic drugs for major ventricular dysrhythmias

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

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom MacroglobulinemiaLymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Lawrence G. Lum, MD, DSc

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 5, 2014

Record last verified: 2014-03