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

2016년 7월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

4

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

59년 이하 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

  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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 에토포사이드
IV
의약품: 시타라빈
IV
의약품: 멜팔란
IV
의약품: 카머스틴
IV
의약품: tacrolimus
IV
의약품: methotrexate
IV
의약품: sargramostim
IV
절차: transplant

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
disease free survival
기간: up to 5 years post-transplant
up to 5 years post-transplant

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Koen Van Besien, MD, University of Chicago

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2000년 11월 1일

기본 완료 (실제)

2003년 2월 1일

연구 완료 (실제)

2003년 2월 1일

연구 등록 날짜

최초 제출

2000년 12월 6일

QC 기준을 충족하는 최초 제출

2003년 1월 26일

처음 게시됨 (추정)

2003년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 7월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 7월 15일

마지막으로 확인됨

2016년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CALGB-59908
  • U10CA031946 (미국 NIH 보조금/계약)
  • CLB-59908
  • CDR0000068324 (레지스트리 식별자: NCI Physician Data Query)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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