NCT00176475

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. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

3.1 years

First QC Date

September 12, 2005

Last Update Submit

September 13, 2013

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult lymphoblastic lymphomarecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiarecurrent small lymphocytic lymphomarefractory hairy cell leukemiaprolymphocytic leukemiarecurrent marginal zone lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarefractory multiple myelomarecurrent mantle cell lymphomarecurrent adult grade III lymphomatoid granulomatosisWaldenstrom macroglobulinemiasplenic marginal zone lymphomastage II multiple myelomastage III multiple myelomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult Hodgkin lymphomastage IV adult lymphoblastic lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult Hodgkin lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaprogressive hairy cell leukemia, initial treatment

Outcome Measures

Primary Outcomes (1)

  • Toxicity as assessed by NCI CTCAE v3.0

    4 years

Secondary Outcomes (1)

  • Efficacy

    4 years

Study Arms (1)

Therapeutic allogeneic lymphocytes with rituximab

EXPERIMENTAL
Biological: rituximabBiological: therapeutic allogeneic lymphocytes

Interventions

rituximabBIOLOGICAL

Patients will receive a single day infusion of standard dose rituximab (375 mg/m2) on days -1, 6, 13, 20 approximately every 4 months (in conjunction with alternating doses of the lymphocyte infusion).

Therapeutic allogeneic lymphocytes with rituximab
therapeutic allogeneic lymphocytesBIOLOGICAL

The product will then be assigned to the specific patient and the released product will be transported to and administered to the patient at CINJ, after premedication of the patient with acetaminophen 650 mg PO and diphenhydramine- HCl 25 mg PO. Blood product administration will be every 8 weeks and undertaken according to CINJ standard procedures

Therapeutic allogeneic lymphocytes with rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed lymphoproliferative disease * CD20-positive disease * Bidimensionally measurable disease OR abnormal cells detected in blood * Resistant or refractory to standard therapies and/or unlikely to benefit from additional standard therapies\* AND meets 1 of the following criteria: * Disease with anticipated response rate \< 20% after treatment with rituximab alone, including any of the following: * Diffuse large cell lymphoma * B-cell lymphoblastic lymphoma * Burkitt's lymphoma * Acute lymphocytic leukemia * Relapsed or progressive disease after prior treatment with rituximab, including any of the following: * Hodgkin's lymphoma * Hairy cell leukemia * Chronic lymphocytic leukemia/small lymphocytic lymphoma meeting any of the following criteria: * Received prior fludarabine phosphate-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies * Received prior anti-CD52 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy) * Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment * B-cell prolymphocytic leukemia meeting any of the following criteria: * Received prior fludarabine phosphate- or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible 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) * Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria: * Received prior fludarabine phosphate- and/or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies * Received prior anti-CD20 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy * Received prior radioconjugated anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy * Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment * Multiple myeloma meeting any of the following criteria: * Received prior alkylating agent-, thalidomide-, corticosteroid-, or bortezomib-containing regimens and relapsed after 1 year of treatment OR ineligible to receive such therapies due to comorbidities or allergies * Received prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy * Mantle cell lymphoma meeting the following criteria: * Received prior combination chemotherapy and anti-CD20 monoclonal antibody therapy and relapsed after treatment OR ineligible to receive such therapy * Diffuse large B-cell lymphoma meeting any of the following criteria: * Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy * Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR not a candidate to receive such therapy * Received prior radiolabeled anti-CD20 monoclonal antibody therapy for transformed large cell lymphoma OR ineligible to receive such therapy * Burkitt's lymphoma meeting any of the following criteria: * Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy * Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy * Lymphomatoid granulomatosis meeting any of the following criteria: * Received prior single-agent or combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy * Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment * Acute lymphocytic leukemia meeting any of the following criteria: * Received prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses and relapsed during or after treatment OR ineligible to receive such therapy * Received prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplantation (HSCT) and relapsed after treatment OR not a candidate for such therapy * Received prior treatment with chemotherapy with or without radiotherapy followed by allogeneic HSCT and relapsed after treatment (or not a candidate for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization, or molecular (reverse transcriptase-polymerase chain reaction) evidence of the bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate NOTE: \*Not eligible to receive standard available salvage regimens anticipated to result in durable remission * No active CNS malignancy * Not considered a candidate for allogeneic HSCT * HLA-partially matched (≥ 2/6) related donor available PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 3 months * Not pregnant * Negative pregnancy test * Fertile women must use effective contraception * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST \< 3.0 times ULN * Cardiac ejection fraction \> 35% * Absolute neutrophil count \> 1,000/mm³ (without cytokines) * Platelet count \> 50,000/mm³ (untransfused) * No significant organ dysfunction * No active uncontrolled infections * No hypersensitivity reaction to rituximab that has precluded completion of a 4-week course of rituximab therapy * No uncontrolled psychiatric illness or medical condition that would preclude tolerance of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy for at least 7 days * More than 30 days since prior cytotoxic chemotherapy * At least 14 days since prior steroids * At least 14 days since prior radiotherapy to non-target lesions

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

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, ProlymphocyticLymphoma, FollicularLymphoma, Mantle-CellWaldenstrom Macroglobulinemia

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, B-CellLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Roger Strair, MD, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

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

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

US(1)