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Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

17. juli 2015 oppdatert av: City of Hope Medical Center

High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma

RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • To evaluate the outcome of patients with poor-risk, age-adjusted International Prognostic Index high- and high-intermediate-risk, intermediate- and high-grade non-Hodgkin lymphoma undergoing high-dose therapy comprising etoposide and cyclophosphamide, either carmustine or total-body irradiation, and autologous stem cell transplantation (ASCT) given as a consolidation therapy.
  • To evaluate the role of high-dose therapy and ASCT during first partial or complete remission (1PR/CR) in patients with poor-risk primary mediastinal large cell lymphoma.
  • To evaluate the role of high-dose therapy and ASCT during first 1PR/CR in patients with advanced-stage mantle cell lymphoma.
  • To evaluate the short-term and long-term toxicities of high-dose therapy and ASCT when performed during 1PR/CR in patients with poor-risk aggressive lymphomas.

OUTLINE: Patients are stratified according to disease (diffuse mixed, diffuse large cell, and immunoblastic lymphoma vs primary mediastinal large cell lymphoma vs small noncleaved cell lymphoma vs stage IV mantle cell lymphoma).

Patients' peripheral blood stem cells (PBSC) are collected after mobilization. A minimum of 2.0 x 10^6 CD34+ cells/kg must be collected. Patients experiencing disease progression during stem cell collection will be removed from study. Patients are assigned to undergo 1 of 2 therapeutic regimens.

  • Regimen 1: Patients undergo total-body irradiation (TBI) on days -8 to -5 and receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo autologous PBSC transplantation on day 0.
  • Regimen 2 (for patients who have received any prior thoracic irradiation or patients who underwent previous irradiation that precludes the use of TBI): Patients receive carmustine IV over 2 hours on days -7 to -5. Patients then receive etoposide and cyclophosphamide and undergo autologous PBSC transplantation as in regimen 1.

Patients with residual bulky disease greater than 5 cm may undergo involved-field radiotherapy before or after transplantation.

Patients are followed at days 7, 14, 21, 100 and 180 after PBSC transplantation, every 6 months for 3 years, and then annually thereafter.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006
        • Good Samaritan Regional Medical Center
    • California
      • Duarte, California, Forente stater, 91010-3000
        • City of Hope National Medical Center--Main Campus

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 59 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • DISEASE CHARACTERISTICS:
  • Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma [SNCCL] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL)

  • SNCCL patients with all of the following factors at presentation of disease:

    • Lactate dehydrogenase (LDH) > 500 IU/L
    • Unresectable bulky mass > 10 cm
    • Stage IV disease with bone marrow involvement
  • MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis
  • Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI
  • Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4
  • Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass > 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan
  • Must have attained a complete response or partial response to first-line standard conventional chemotherapy
  • ECOG PS 0-1 OR Karnofsky PS 80-100%
  • Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
  • FEV_1 > 65% of predicted measurement or DLCO ≥ 45% of predicted measurement
  • Cardiac ejection fraction > 50% by echocardiogram
  • Bilirubin ≤ 1.5 x normal
  • SGOT or SGPT ≤ 2 x normal

Exclusion Criteria:

  • Evidence of lymphoma or < 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy
  • Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
  • Positive HIV antibody
  • Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin
  • Hepatitis B surface antigen positivity
  • Prior bone marrow transplantation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior bone marrow transplantation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Irradiation in conditioning
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematologic stem cell transplantation, peripheral blood stem cell transplantation
Legemiddel: cyclophosphamide
Used in Both Arms
Andre navn:
  • Cytoxan, CTX
Legemiddel: etoposide
Used in Both Arms
Andre navn:
  • VP-16
Fremgangsmåte: autologous hematopoietic stem cell transplantation
Both arms are given autologous stem cell transplantation
Fremgangsmåte: peripheral blood stem cell transplantation
Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).
Stråling: total-body irradiation
Unique to the Radiation in Conditioning Arm
Legemiddel: G-CSF
G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
Andre navn:
  • Granulocytt-kolonistimulerende faktor
Aktiv komparator: Carmustine in conditioning
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
Legemiddel: cyclophosphamide
Used in Both Arms
Andre navn:
  • Cytoxan, CTX
Legemiddel: etoposide
Used in Both Arms
Andre navn:
  • VP-16
Fremgangsmåte: autologous hematopoietic stem cell transplantation
Both arms are given autologous stem cell transplantation
Fremgangsmåte: peripheral blood stem cell transplantation
Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).
Legemiddel: G-CSF
G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
Andre navn:
  • Granulocytt-kolonistimulerende faktor
Legemiddel: carmustine
Unique to the Carmustine in Conditioning arm
Andre navn:
  • BCNU

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression
Tidsramme: Assessed at date of progression post-transplant

Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.

Below is reported Progression-free Survival: event is relapse or progression, or death.
Assessed at date of progression post-transplant
Mortality
Tidsramme: Assessed at date of death post-transplant
Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.
Assessed at date of death post-transplant

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Short-term and Long-term Treatment-related Toxicities
Tidsramme: Any time after transplant
Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.
Any time after transplant

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City of Hope Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 1998

Primær fullføring (Faktiske)

1. juli 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

15. november 2007

Først innsendt som oppfylte QC-kriteriene

15. november 2007

Først lagt ut (Anslag)

16. november 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 97133
  • P30CA033572 (U.S. NIH-stipend/kontrakt)
  • CHNMC-97133 (Annen identifikator: City of Hope)
  • CDR0000573523 (Registeridentifikator: NCI PDQ)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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