Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor
Official Title
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies
Acronym
Not provided
Organization
Rutgers, The State University of New JerseyOTHER
Status Module
Record Verification Date
Sep 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2001
Primary Completion Date
Oct 2010Actual
Completion Date
Oct 2011Actual
First Submitted Date
Sep 8, 2005
First Submission Date that Met QC Criteria
Sep 8, 2005
First Posted Date
Sep 12, 2005Estimated
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
Nov 5, 2015
Last Update Posted Date
Nov 6, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of Medicine and Dentistry of New JerseyOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells.
PURPOSE: This pilot study is looking at the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor.
Detailed Description
OBJECTIVES:
Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients with relapsed or refractory hematological cancer or solid tumor.
Determine the response in patients treated with this regimen.
Determine the presence of disease or antigen-specific lymphocytes in patients treated with this regimen.
OUTLINE: This is a pilot, open-label, controlled study.
Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1. Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for lymphocytotoxicity directed towards patients' cells (normal and malignant cells) and for disease or antigen-specific cells. Samples are also analyzed for survival of donor lymphocytes by chimerism studies.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
refractory chronic lymphocytic leukemia
recurrent small lymphocytic lymphoma
prolymphocytic leukemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent marginal zone lymphoma
splenic marginal zone lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent mantle cell lymphoma
childhood diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
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
Biospecimen
No data available
No data is available for this block.
Enrollment
37Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment
Experimental
Biological/Vaccine: therapeutic allogeneic lymphocytes The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
Biological: therapeutic allogeneic lymphocytes
Interventions
Name
Type
Description
Arm Group Labels
Other Names
therapeutic allogeneic lymphocytes
Biological
The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Toxicity
10 years
Secondary Outcomes
Measure
Description
Time Frame
Response
10 years
Presence of disease or antigen-specific lymphocytes
10 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Hematologic cancer, including any of the following:
Chronic lymphocytic leukemia or small lymphocytic lymphoma meeting any of the following criteria:
Relapsed within 1 year after prior fludarabine phosphate-containing regimens OR not a candidate to receive such therapy due to comorbidities or allergies
Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment
B- or T-cell prolymphocytic leukemia meeting any of the following criteria:
Relapsed within 1 year after prior fludarabine phosphate- or alkylating agent-containing regimens OR not a candidate to receive such therapy due to comorbidities or allergies
Relapsed within 1 year after prior anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy (for patients with CD20-positive disease)
Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:
Relapsed within 1 year after prior fludarabine phosphate- or alkylating agent-containing regimens or radioconjugated anti-CD20 monoclonal antibody OR not a candidate to receive such therapy due to comorbidities or allergies
Relapsed within 1 year after prior anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy (for patients with CD20-positive disease)
Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment
Multiple myeloma meeting any of the following criteria:
Relapsed after prior alkylating agents, thalidomide, corticosteroids, or bortezomib OR not a candidate to receive such therapy due to comorbidities or allergies
Relapsed after prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
Mantle cell lymphoma that has relapsed after prior combination chemotherapy or anti-CD20 monoclonal antibody OR not a candidate to receive such therapy
Diffuse large B-cell lymphoma meeting any of the following criteria:
Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
Received prior radiolabeled anti-CD20 monoclonal antibody OR ineligible to receive such therapy (for patients with transformed large cell lymphoma)
Burkitt's lymphoma
Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate for such therapy
Lymphomatoid granulomatosis or mature T-cell or NK-cell neoplasms meeting any of the following criteria:
Relapsed after prior single agent or combination chemotherapy OR not a candidate to receive such therapy
Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment
Mycosis fungoides or Sezary syndrome
Relapsed after prior combination chemotherapy, interferon-α, denileukin diftitox, or extracorporeal photophoresis OR not a candidate to receive such therapy
Anaplastic large cell lymphoma, peripheral T-cell lymphoma unspecified, or angioimmunoblastic T-cell lymphoma meeting the following criteria:
Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
Hepatosplenic T-cell lymphoma or adult T-cell leukemia/lymphoma
Relapsed after prior salvage combination chemotherapy OR not a candidate to receive such therapy
Hodgkin's lymphoma
Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
Acute lymphocytic leukemia meeting any of the following criteria:
Relapsed during or after prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses OR not a candidate to receive such therapy
Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
Relapsed after prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplant (or ineligible for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization (FISH), or molecular (reverse transcriptase-polymerase chain reaction) evidence of bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate
Acute myelogenous leukemia or myelodysplasia meeting any of the following criteria:
Relapsed or refractory disease after prior induction chemotherapy (anthracycline and cytarabine, topotecan hydrochloride and cytarabine, or comparable regimen) OR not a candidate to receive such therapy
Not a candidate for chemotherapy with or without radiotherapy followed by allogeneic or autologous hematopoietic stem cell transplant
Patients with acute promyelomonocytic leukemia must have received prior tretinoin and arsenic trioxide
Chronic myelogenous leukemia meeting any of the following criteria:
Relapsed or refractory disease after prior imatinib mesylate
Not a candidate for chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplant
Chronic phase disease allowed if there is FISH or cytogenetic evidence of increasing disease
Solid tumor, including any of the following:
Renal cell carcinoma
Metastatic relapsed or refractory disease after prior high-dose aldesleukin OR ineligible to receive such therapy due to comorbidities OR did not consent to treatment
Bladder cancer or gastric cancer
Metastatic relapsed or refractory disease after prior combination therapy OR not a candidate to receive such therapy
Prostate cancer
Metastatic relapsed or refractory disease after prior hormonal therapy OR not a candidate to receive such therapy
Testicular cancer
Metastatic relapsed or refractory disease after prior standard induction or salvage chemotherapy or high-dose chemotherapy with autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
Pancreatic cancer
Metastatic relapsed or refractory disease after prior gemcitabine hydrochloride-based therapy OR not a candidate to receive such therapy
Hepatocellular carcinoma
Unresectable or metastatic disease
Colorectal carcinoma
Metastatic relapsed or refractory disease after prior combination therapy, including fluorouracil with or without leucovorin calcium, oxaliplatin, or irinotecan hydrochloride OR not a candidate to receive such therapy
Breast cancer meeting any of the following criteria:
Metastatic relapsed or refractory disease after prior first- or second-line standard combination chemotherapy OR not a candidate to receive such therapy
Received prior trastuzumab (Herceptin®) and sequential hormonal therapy OR not a candidate to receive such therapy as indicated by the biological characteristics of the cancer
Lung cancer (non-small cell or small cell lung cancer), ovarian cancer, endometrial cancer, or cervical cancer
Metastatic relapsed or refractory disease after prior first- or second-line combination chemotherapy OR not a candidate to receive such therapy
Malignant melanoma
Metastatic relapsed or refractory disease after prior immunotherapy or combination chemotherapy OR not a candidate to receive such therapy
Sarcoma meeting any of the following criteria:
Metastatic relapsed or refractory disease after prior first- or second-line combination chemotherapy OR not a candidate to receive such therapy
Not a candidate for resection
Patients with gastrointestinal stromal tumors must have received prior imatinib mesylate
Measurable disease
Must have received prior available standard therapy for specific disease OR not a candidate for this treatment
No CNS malignancy
HLA-partially matched (≥ 2/6 HLA antigen [A, B, DR]) related donor (above 18 years of age) available
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy > 3 months
Bilirubin < 1.5 times upper limit of normal (ULN)
AST < 3.0 times ULN
LVEF > 35%
No active infections
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled medical or psychiatric illness that would preclude study compliance, in the opinion of the investigator
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Roger Strair, MD, PhD
Rutgers Cancer Institute of New Jersey
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick
New Jersey
08903
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D015463
Leukemia, Prolymphocytic
D018442
Lymphoma, B-Cell, Marginal Zone
D008224
Lymphoma, Follicular
D009101
Multiple Myeloma
D020522
Lymphoma, Mantle-Cell
D016403
Lymphoma, Large B-Cell, Diffuse
D002051
Burkitt Lymphoma
D054391
Lymphoma, Extranodal NK-T-Cell
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D017728
Lymphoma, Large-Cell, Anaplastic
D007119
Immunoblastic Lymphadenopathy
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D006689
Hodgkin Disease
D012008
Recurrence
D015470
Ancestor Terms
ID
Term
D015448
Leukemia, B-Cell
D007945
Leukemia, Lymphoid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
recurrent adult Burkitt lymphoma
recurrent adult grade III lymphomatoid granulomatosis
recurrent childhood grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
childhood nasal type extranodal NK/T-cell lymphoma