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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

15 luglio 2016 aggiornato da: Alliance for Clinical Trials in Oncology

Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

  • Determine the long term disease-free survival of patients with mantle cell lymphoma treated with etoposide, carmustine, melphalan, and cytarabine followed by allogeneic peripheral blood stem cell transplantation.
  • Determine the incidence of molecular remissions in these patients treated with this regimen.
  • Correlate the persistence of minimal residual disease with clinical outcome in these patients treated with this regimen.
  • Determine the effect of donor lymphocytes in patients with progressive disease after treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover.

Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists.

Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233-1996
        • Veterans Affairs Medical Center - Birmingham
    • California
      • La Jolla, California, Stati Uniti, 92093-0658
        • University of California San Diego Cancer Center
      • San Francisco, California, Stati Uniti, 94121
        • Veterans Affairs Medical Center - San Francisco
      • San Francisco, California, Stati Uniti, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Delaware
      • Wilmington, Delaware, Stati Uniti, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Stati Uniti, 20007
        • Lombardi Cancer Center
    • Florida
      • Miami Beach, Florida, Stati Uniti, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, Stati Uniti, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, Stati Uniti, 60637-1470
        • University of Chicago Cancer Research Center
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242-1009
        • Holden Comprehensive Cancer Center
    • Maine
      • Togus, Maine, Stati Uniti, 04330
        • Veterans Affairs Medical Center - Togus
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, Stati Uniti, 01655
        • University of Massachusetts Memorial Medical Center - University Campus
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, Stati Uniti, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198-7680
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center
    • New York
      • Buffalo, New York, Stati Uniti, 14263-0001
        • Roswell Park Cancer Institute
      • Buffalo, New York, Stati Uniti, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Manhasset, New York, Stati Uniti, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Stati Uniti, 11030
        • North Shore University Hospital
      • New York, New York, Stati Uniti, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Stati Uniti, 10021
        • New York Presbyterian Hospital - Cornell Campus
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai Medical Center, NY
      • Syracuse, New York, Stati Uniti, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, Stati Uniti, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, Stati Uniti, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, Stati Uniti, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Stati Uniti, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, Stati Uniti, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38104
        • Veterans Affairs Medical Center - Memphis
      • Memphis, Tennessee, Stati Uniti, 38103
        • University of Tennessee Cancer Institute
    • Vermont
      • Bennington, Vermont, Stati Uniti, 05201
        • Green Mountain Oncology Group
      • Burlington, Vermont, Stati Uniti, 05401-3498
        • Vermont Cancer Center
      • White River Junction, Vermont, Stati Uniti, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Richmond, Virginia, Stati Uniti, 23249
        • Veterans Affairs Medical Center - Richmond

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 59 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

  1. Documentation of Disease

    1. Histologically documented mantle cell lymphoma of any stage (needle or core biopsy is not acceptable as the sole means of diagnosis) with at least one of the following confirmatory tests indicative of diagnosis:

      • Immunophenotype with expression of CD5 and CD19 and absence of CD23
      • Cytogenetic analysis with presence of t(11;14)
      • Overexpression of cyclin D1
      • Rearrangement of BCL1 gene
    2. Rebiopsy of a node at relapse is recommended but not required.
    3. Bone marrow biopsy required for pretreatment evaluation. Bilateral biopsies are not required.
  2. Identification of HLA-Matched sibling donor - The sibling donor must meet eligibility criteria outlined in section 5.0

  3. Prior Therapy

    1. Patients who have failed initial therapy are eligible (without any of the poor prognostic characteristics listed in the protocol). Failure to initial treatment is defined as one of the following:

      • Failure to achieve clinical complete remission after treatment with an anthracycline-containing regimen
      • Disease recurrence after initial treatment (with an anthracycline-containing regimen)

    2. Patients in first remission must have one of the following poor prognostic characteristics:

      • International Prognostic Index (IPI) score > 1. IPI risk factors include the following: age > 60 (not eligible for this protocol); performance status > 1; LDH > normal; presence of > 1 extranodal sites; and stage III/IV disease
      • Blastic variant of mantle cell lymphoma (regardless of IPI score)
      • Complex karyotypes (i.e., cytogenetic abnormalities different from or in addition to t(11;14) (regardless of IPI score)
      • Proliferative index > 10% (regardless of IPI score)
      • Presence of p53 mutations
    3. Patients who have received more than two chemotherapy regimens are ineligible. Patients who have undergone a prior bone marrow transplant are not eligible.
  4. Age < 60 years
  5. No active CNS lymphoma
  6. DLCO ≥ 40% and no symptomatic pulmonary disease
  7. No HIV infection
  8. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.

  9. Initial required laboratory values

    • bilirubin < 2 mg/dl
    • AST ≤ 3 x upper limit of normal (ULN)
    • ALT ≤ 3 x ULN
    • serum creatinine < 2 mg/dl
    • u-HCG or serum HCG negative (if patient of childbearing potential)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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
Sperimentale: chemotherapy + stem cell transplantation

Patients receive carmustine, etoposide, cytarabine and melphalan on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus on day -2 and then orally twice daily until day 120 and methotrexate on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim daily beginning on day 7 and continuing until blood counts recover.

Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists.

Patients are followed at 6 and 12 months post-transplantation and then annually for 4 years.
Droga: etoposide
IV
Droga: citarabina
IV
Droga: melfalan
IV
Droga: carmustina
IV
Droga: tacrolimus
IV
Droga: methotrexate
IV
Droga: sargramostim
IV
Procedura: transplant

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
disease free survival
Lasso di tempo: up to 5 years post-transplant
up to 5 years post-transplant

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Koen Van Besien, MD, University of Chicago

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2000

Completamento primario (Effettivo)

1 febbraio 2003

Completamento dello studio (Effettivo)

1 febbraio 2003

Date di iscrizione allo studio

Primo inviato

6 dicembre 2000

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 luglio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CALGB-59908
  • U10CA031946 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CLB-59908
  • CDR0000068324 (Identificatore di registro: NCI Physician Data Query)

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 .

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