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Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL

2019년 8월 19일 업데이트: Patrick Stiff, Loyola University

Phase I Study of Autologous Transplant Conditioned by Dose-Escalated Total Body Irradiation (TBI) and Standard Doses of Cyclophosphamide and Palifermin (Kepivance) for High Risk Non-Hodgkins Lymphoma

Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an autologous transplant are likely to suffer a relapse because standard myeloablative preparative regimens are unable to produce a cure. The majority of these participants do not have a stem cell donor available, are too frail to undergo an allogeneic transplant, or refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma have had a very poor outcome.

To take advantage of the low transplant related mortality associated with an autologous transplantation, the investigators propose modifying the preparative regimen to make it more effective without increasing toxicity. By increasing the dose of radiation while administering the protective growth factor palifermin (Kepivance), the investigators hope to decrease the risk of relapse without increasing transplant related mortality.

Three prospective randomized trials have studied different radiation schemes as a part of the TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients with AML or CML. As a group these trials showed that higher doses of TBI in these older studies decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three retrospective studies have also postulated that higher dose radiation led to less risk of relapse.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a non-randomized, open-label phase I trial in participants with non-Hodgkin's lymphoma. The preparative regimen will be as follows:

Day -10 (prior to transplant) Palifermin treatment to prevent mouth sores Day -9 Palifermin treatment to prevent mouth sores Day -8 Palifermin treatment to prevent mouth sores Day -7 Total Body Irradiation twice a day Day -6 Total Body Irradiation twice a day Day -5 Total Body Irradiation twice a day Day -4 Total Body Irradiation twice a day Day -3 Cytoxan chemotherapy infusion Day -2 Cytoxan chemotherapy infusion Day -1 Day of rest Day 0 Stem cell infusion (bone marrow transplant), Palifermin treatment to prevent mouth sores and G-CSF given daily until stem cells take hold (engraftment) occurs.

Day +1 Palifermin treatment to prevent mouth sores Day +2 Palifermin treatment to prevent mouth sores

연구 유형

중재적

등록 (실제)

17

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Illinois
      • Maywood, Illinois, 미국, 60153
        • Patrick Stiff, MD

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age 18 years of age or older
  • Participants scheduled to undergo autologous stem cell transplantation with relapsed or refractory non-Hodgkin's Lymphoma with less than a partial remission to salvage therapy.
  • Participants scheduled to undergo autologous stem cell transplantation with relapsed or refractory non-Hodgkin's Lymphoma with any site of disease 2 cm or greater on pre-transplant imaging.
  • Participants must have a performance status (PS) of 0-1.
  • Participants must have acceptable kidney function.
  • Acceptable pulmonary function test of the lungs.
  • Acceptable liver function tests.

Exclusion Criteria:

  • Participants must not have cutaneous T-cell, mantle cell, or lymphoblastic lymphoma.
  • Participants must not have prior peripheral blood or marrow transplantation.
  • Participants must not have prior radiation.
  • Participants must not have significant history of uncontrolled cardiac disease; for example, uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
  • Participants must not have active bacterial, fungal, or viral infection.

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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dose Level 1
The participants will receive Palifermin on Day -10, -9 and -8. Total Body Irradiation 1.64 Gy per Fraction for a total of 8 Fractions. The total amount would be 13.12 Gy. The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4). Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2). The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. Participants will receive Palifermin on Day 0, +1 and +2.
방사능: Total body irradiation
When radiation is given in a way to cover the whole body, it is called total body irradiation.
실험적: Dose Level 2
The participants will receive Palifermin on Day -10, -9 and -8. Total Body Irradiation 1.76 Gy per Fraction for a total of 8 Fractions. The total amount would be 14.08 Gy. The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4). Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2). The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. Participants will receive Palifermin on Day 0, +1 and +2.
방사능: Total body irradiation
When radiation is given in a way to cover the whole body, it is called total body irradiation.
실험적: Dose Level 3
The participants will receive Palifermin on Day -10, -9 and -8. Total Body Irradiation 1.88 Gy per Fraction for a total of 8 Fractions. The total amount would be 15.04 Gy. The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4). Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2). The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. Participants will receive Palifermin on Day 0, +1 and +2.
방사능: Total body irradiation
When radiation is given in a way to cover the whole body, it is called total body irradiation.
실험적: Dose Level 4
The participants will receive Palifermin on Day -10, -9 and -8. Total Body Irradiation 2.00 Gy per Fraction for a total of 8 Fractions. The total amount would be 16 Gy. The participants will receive total body irradiation twice a day for four days (Day -7, -6, -5, and Day -4). Over the following two days, the participants will receive cyclophosphamide (Day -3 and -2). The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs. Participants will receive Palifermin on Day 0, +1 and +2.
방사능: Total body irradiation
When radiation is given in a way to cover the whole body, it is called total body irradiation.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Determine the frequency and severity of adverse events by evaluating grade 3 and grade 4 adverse events.
기간: 4 weeks

Any grade 3 or 4 dose limiting toxicities as described : • Heart failure with only minor response to medical therapy

  • Hemorrhagic cystitis with frank blood requiring sclerosing agent or other surgical procedure
  • Acute kidney failure requiring dialysis
  • Interstitial pneumonitis requiring ventilatory support or FiO2 > 50% x 24hrs
  • Bilirubin > 20 mg/dL
  • Unexplained seizures or coma
  • Severe mucositis requiring intubation for airway protection
  • Ileus requiring nasogastric decompression.
  • Death
4 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Blood work will be used to evaluate recovery of white blood cells, red blood cells and platelets.
기간: 4 weeks
To evaluate labwork during treatment and for 28 days post treatment
4 weeks
Pulmonary Function Test will be used to evaluate side effects of total body irradiation
기간: 1 year
Pulmonary Function Test will be used to evaluate side effects of total body irradiation.
1 year
CT scan or physical exam will be used to evaluate progression free survival.
기간: 1 year
CT scan or physical exam will be used to evaluate progression free survival as deemed necessary.
1 year
Mucositis measured by investigators.
기간: At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
Mucositis physical examination done by investigators by accessing the mouth using the WHO (World Health Organization) oral toxicity scale.
At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
Number of participants with Grade 4 through 5 Adverse Events that are related to study treatment, grading according to NCI CTCAE Version 3.
기간: 28 days post treatment
Dose-limiting toxicities that are probably or definitely related to the treatment regimen.
28 days post treatment
Mucositis measured by oral mucositis questionnaires
기간: At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.
The participants will complete the oral mucositis daily questionnaires prior to the physical assessment. The questionnaire includes the participants self-reported mouth and throat soreness.
At the start of treatment and daily until mucositis resolves or 28 days post transplant whichever comes first.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Loyola University

수사관

  • 수석 연구원: Patrick Stiff, MD, Loyola University

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

2006년 6월 1일

기본 완료 (실제)

2018년 12월 1일

연구 완료 (실제)

2018년 12월 1일

연구 등록 날짜

최초 제출

2017년 1월 4일

QC 기준을 충족하는 최초 제출

2017년 2월 2일

처음 게시됨 (추정)

2017년 2월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 8월 19일

마지막으로 확인됨

2019년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 108993

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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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