- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00176475
Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes in Conjunction With Rituximab for Selected Patients With CD20 + Malignancies
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymphoproliferative disease.
- Determine the efficacy of this regimen in these patients.
Secondary
- Correlate response with Fc receptor FcγIIIA polymorphisms or predicted HLA-directed natural killer cell reactivity.
OUTLINE: This is a pilot study.
- Rituximab therapy: Patients receive rituximab IV on days -1, 6, 13, and 20. Treatment repeats approximately every 4 months in the absence of disease progression or unacceptable toxicity.
- Donor lymphocyte infusion: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks (alternating with courses of rituximab therapy) for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.
Peripheral blood is collected periodically during study for correlative laboratory studies. Blood samples are analyzed for FcγIIIA polymorphism by fluorescent in situ hybridization or by reverse transcriptase-polymerase chain reaction. Survival of donor lymphocytes is assessed by chimerism studies.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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New Jersey
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New Brunswick, New Jersey, Stati Uniti, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Therapeutic allogeneic lymphocytes with rituximab
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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).
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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Toxicity as assessed by NCI CTCAE v3.0
Lasso di tempo: 4 years
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4 years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Efficacy
Lasso di tempo: 4 years
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4 years
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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- linfoma diffuso a grandi cellule dell'adulto in stadio III
- Linfoma di Burkitt adulto stadio III
- linfoma follicolare di grado 3 stadio IV
- linfoma diffuso a grandi cellule dell'adulto in stadio IV
- Linfoma di Burkitt adulto stadio IV
- linfoma follicolare ricorrente di grado 3
- linfoma diffuso a grandi cellule dell'adulto ricorrente
- linfoma di Burkitt ricorrente dell'adulto
- linfoma di Hodgkin ricorrente dell'adulto
- Macroglobulinemia di Waldenstrom
- linfoma follicolare stadio III grado 1
- linfoma follicolare stadio III grado 2
- linfoma follicolare stadio III grado 3
- linfoma follicolare stadio IV grado 1
- linfoma follicolare in stadio IV grado 2
- linfoma mantellare in stadio III
- linfoma mantellare in stadio IV
- Mieloma multiplo stadio II
- mieloma multiplo stadio III
- linfoma follicolare ricorrente di grado 1
- linfoma follicolare ricorrente di grado 2
- linfoma ricorrente della zona marginale
- piccolo linfoma linfocitico ricorrente
- piccolo linfoma linfocitico stadio III
- linfoma della zona marginale in stadio III
- piccolo linfoma linfocitico stadio IV
- linfoma della zona marginale in stadio IV
- linfoma a cellule B della zona marginale extranodale del tessuto linfoide associato alla mucosa
- linfoma a cellule B della zona marginale nodale
- linfoma splenico della zona marginale
- linfoma linfoblastico ricorrente dell'adulto
- linfoma mantellare ricorrente
- leucemia linfatica cronica refrattaria
- leucemia linfatica cronica stadio III
- leucemia linfocitica cronica in stadio IV
- linfoma di Hodgkin adulto stadio III
- Linfoma di Hodgkin adulto stadio IV
- Linfoma linfoblastico adulto stadio III
- Linfoma linfoblastico adulto stadio IV
- granulomatosi linfomatoide ricorrente di grado III dell'adulto
- mieloma multiplo refrattario
- leucemia linfoblastica acuta ricorrente dell'adulto
- leucemia a cellule capellute refrattaria
- leucemia prolinfocitica
- leucemia a cellule capellute progressiva, trattamento iniziale
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Linfoma
- Mieloma multiplo
- Neoplasie, plasmacellule
- Leucemia
- Plasmocitoma
- Effetti fisiologici delle droghe
- Agenti antireumatici
- Agenti antineoplastici
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Rituximab
Altri numeri di identificazione dello studio
- CDR0000540171
- P30CA072720 (Sovvenzione/contratto NIH degli Stati Uniti)
- CINJ-010406 (Altro identificatore: Cancer Institute of New Jersey)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su rituximab
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Children's Oncology GroupNational Cancer Institute (NCI)Attivo, non reclutanteDisturbo linfoproliferativo post-trapianto correlato all'EBV | Disturbo linfoproliferativo post-trapianto monomorfico | Disordine linfoproliferativo post-trapianto polimorfico | Disturbo linfoproliferativo post-trapianto monomorfico ricorrente | Disturbo linfoproliferativo post-trapianto polimorfico... e altre condizioniStati Uniti
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ReclutamentoLinfoma follicolare di Ann Arbor stadio I grado 1 | Linfoma follicolare di stadio I grado 2 di Ann Arbor | Linfoma follicolare di grado 1 di stadio II di Ann Arbor | Linfoma follicolare di Ann Arbor stadio II grado 2Stati Uniti
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Attivo, non reclutanteLinfoma follicolare ricorrente di grado 1 | Linfoma follicolare ricorrente di grado 2 | Linfoma Mantellare Ricorrente | Linfoma ricorrente della zona marginale | Linfoma non Hodgkin a cellule B refrattario | Piccolo linfoma linfocitico ricorrente | Linfoma non Hodgkin ricorrente a cellule B | Linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)CompletatoLinfoma follicolare di Ann Arbor stadio III grado 1 | Linfoma follicolare di stadio III grado 2 di Ann Arbor | Linfoma follicolare di Ann Arbor stadio IV grado 1 | Linfoma follicolare di stadio IV grado 2 di Ann Arbor | Linfoma follicolare contiguo di grado 3 di stadio II di Ann Arbor | Linfoma... e altre condizioniStati Uniti
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutantePiccolo linfoma linfocitico ricorrente | Leucemia prolinfocitica | Leucemia linfocitica cronica ricorrenteStati Uniti
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National Cancer Institute (NCI)Attivo, non reclutanteLinfoma Mantellare Ricorrente | Linfoma non Hodgkin a cellule B refrattario | Linfoma non Hodgkin ricorrente a cellule B | Linfoma mantellare refrattarioStati Uniti
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Mabion SAParexelRitirato
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National Cancer Institute (NCI)Celgene CorporationAttivo, non reclutanteLinfoma follicolare di Ann Arbor stadio III grado 1 | Linfoma follicolare di stadio III grado 2 di Ann Arbor | Linfoma follicolare di Ann Arbor stadio IV grado 1 | Linfoma follicolare di stadio IV grado 2 di Ann Arbor | Linfoma follicolare contiguo di grado 3 di stadio II di Ann Arbor | Linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)Attivo, non reclutanteLeucemia linfocitica cronica di stadio I | Leucemia linfocitica cronica di stadio II | Leucemia linfocitica cronica di stadio III | Leucemia linfocitica cronica di stadio IVStati Uniti, Canada
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ReclutamentoLeucemia linfocitica cronica/piccolo linfoma linfociticoStati Uniti