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Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer

2021년 7월 19일 업데이트: Roswell Park Cancer Institute

Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which combination chemotherapy regimen is most effective when given before a donor stem cell transplant in treating aplastic anemia or hematologic cancer.

PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer.

연구 개요

상세 설명

OBJECTIVES:

  • Compare the morbidity, mortality, and overall outcome of patients with severe aplastic anemia or hematologic malignancy treated with standard vs novel conditioning regimens followed by allogeneic stem cell transplantation.
  • Examine the influence of donor histocompatibility on outcome by comparing matched/related, mismatched/related (with or without T-cell depletion), and matched/unrelated transplants with stratification for type of preparative regimen.
  • Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with the best therapy available.

OUTLINE: Patients are stratified according to risk of relapse (standard-risk: acute leukemia in first complete remission, chronic myelogenous leukemia in first chronic phase, lymphoma in sensitive first relapse or second remission, primary or untreated myelodysplastic syndromes, or untreated severe aplastic anemia vs high-risk: all others).

Patients are assigned to one of the following conditioning regimens based on diagnosis, risk of relapse, and donor relatedness:

  • Regimen 1: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
  • Regimen 2: Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.
  • Regimen 3: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.
  • Regimen 4: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.
  • Regimen 5: Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.
  • Regimen 6: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
  • Regimen 7: Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.
  • Regimen 8: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
  • Regimen 9: Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

All patients then receive donor stem cell infusions on day 0. Some patients may undergo involved-field radiotherapy 4-8 weeks after transplant.

Patients will be taken off study after a minimum of 4 years of follow up.

PROJECTED ACCRUAL: At least 405 patients will be accrued for this study within 5 years.

연구 유형

중재적

등록 (실제)

361

단계

  • 2 단계
  • 3단계

연락처 및 위치

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

연구 장소

    • New York
      • Buffalo, New York, 미국, 14263-0001
        • Roswell Park Cancer Institute

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

2개월 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:

    • Severe aplastic anemia as defined by either of the following:

      • Marrow cellularity (< 25% [or 25-50% cellularity with < 30% of remaining cells hematopoietic in origin])
      • At least 2 of the following abnormal peripheral blood counts:

        • Reticulocyte count < 1% (corrected for hematocrit)
        • Platelet count < 20,000/mm^3
        • Neutrophil count < 500/mm^3
    • Histologically confirmed hematologic malignancy, including any of the following:

      • Acute leukemia

        • Resistant or recurrent disease after combination chemotherapy with at least one standard regimen OR in first remission and at high risk of relapse
        • Acute myeloid leukemia (AML) (antecedent myelodysplastic syndromes [MDS], secondary AML, or high-risk cytogenetic abnormalities)
        • Acute lymphoblastic leukemia (ALL) (high-risk cytogenetic abnormalities)
      • Chronic myeloid leukemia (CML)

        • Chronic phase, accelerated phase, or blast phase
      • Myeloproliferative disorders or MDS, including any of the following:

        • Myelofibrosis
        • Polycythemia vera*
        • Essential thrombocythemia*
        • Refractory anemia
        • Refractory anemia with excess blasts
        • Refractory anemia with excess blasts in transformation
        • Chronic myelomonocytic leukemia NOTE: * Only if transformed to AML or MDS
      • Lymphoproliferative disease

        • Recurrent or persistent, symptomatic disease after first-line chemotherapy, including any of the following:

          • Chronic lymphocytic leukemia (CLL) (≥ 20% marrow involvement)
          • Waldenstrom macroglobulinemia
          • Low-grade non-Hodgkin lymphoma
      • Intermediate or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria:

        • Resistant or recurrent disease after combination chemotherapy with one standard regimen
        • Lymphoblastic lymphoma or small noncleaved cell lymphoma in first remission and at high risk of relapse
        • CNS disease
        • Bone marrow disease and LDH greater than 300
    • Solid tumor that would otherwise be treated on RPCI-DS-9115 (or equivalent autologous stem transplant protocol) AND has a syngeneic donor
  • Autologous bone marrow transplant not possible (or desirable) due to 1 of the following:

    • History of marrow tumor
    • Inadequate marrow dose
    • Abnormal marrow histology or function prior to storage
    • Thrombocytopenia or leukopenia
    • Marrow cellularity < 20%
  • Histocompatible donor identified

    • Well-matched donor, as defined by 1 of the following:

      • Family member matched for 5 or 6 HLA specificities (A, B, DR)*
      • Unrelated donor meeting compatibility criteria of the National Marrow Donor Program (matched for HLA A, B, and DRB1 antigens)*
      • Identical twin sibling
    • If a compatible cord blood donor is identified and there is no suitable unrelated donor available, patient may receive cord blood transplant NOTE: *Patients ≤ 25 years of age may be singly mismatched at the A or B loci

NOTE: A new classification scheme for adult non-Hodgkin's 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.

PATIENT CHARACTERISTICS:

Age:

  • 4 to 70

Performance status:

  • Zubrod 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin < 3 times normal (unless due to disease)
  • Alkaline phosphatase < 3 times normal (unless due to disease)
  • SGOT < 3 times normal (unless due to disease)
  • Hepatitis B surface antigen negative
  • No severe hepatic disease that would preclude study participation

Renal:

  • Creatinine normal
  • Creatinine clearance ≥ 50 mL/min
  • No severe renal disease that would preclude study participation

Cardiovascular:

  • Cardiac ventricular ejection fraction ≥ 50% by MUGA or echocardiogram
  • No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction, congestive heart failure, symptomatic angina, life threatening arrhythmia, or hypertension within the past 6 months)

Pulmonary:

  • DLCO or DLVA ≥ 50% predicted (corrected for hemoglobin or alveolar ventilation)

Other:

  • No serious concurrent medical or psychiatric illness
  • No other serious organ dysfunction (unless due to underlying disease), including the following:

    • Uncontrolled bacterial, viral, or fungal infection
    • Uncontrolled peptic ulcer disease
    • Uncontrolled diabetes mellitus
  • HIV negative
  • Cytomegalovirus status known
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Pretransplant cytoreductive chemotherapy allowed for patients with relapsed or refractory disease

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not eligible for total-body irradiation if prior radiotherapy exceeded the following limits:

    • Mediastinum: 3,600 cGy
    • Heart: 3,600 cGy
    • Whole lungs: 1,200 cGy
    • Small bowel: 3,600 cGy
    • Kidneys: 1,200 cGy
    • Whole liver: 1,600 cGy
    • Cranial spinal: 3,600 cGy
    • Brain: 4,000 cGy
    • Retina: 4,000 cGy

Surgery:

  • Not specified

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: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Regimen 1
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
주어진 IV
주어진 IV
실험적: Regimen 2
Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.
주어진 IV
주어진 IV
실험적: Regimen 3
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.
주어진 IV
Given twice daily for 3 days
실험적: Regimen 4
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.
주어진 IV
주어진 IV
실험적: Regimen 5
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.
주어진 IV
주어진 IV
Given twice daily for 3 days
실험적: Regimen 6
Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
주어진 IV
주어진 IV
주어진 IV
실험적: Regimen 7
Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.
주어진 IV
주어진 IV
실험적: Regimen 8
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
주어진 IV
주어진 IV
Given twice daily for 3 days
실험적: Regimen 9
Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
주어진 IV
주어진 IV
주어진 IV

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
CR Rate
기간: day 100
Rate of Complete Remission by Day +100
day 100

2차 결과 측정

결과 측정
측정값 설명
기간
Toxicity/TRM at Day 100
기간: Day +100
Death due to treatment related causes before day +100 after BMT
Day +100
4 Year PFS
기간: 4 years
progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)
4 years
4 yr OS
기간: 4-year
Overall survival estimate at 4 years post BMT
4-year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Philip L. McCarthy, MD, Roswell Park Cancer Institute

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 (실제)

1998년 10월 19일

기본 완료 (실제)

2019년 7월 12일

연구 완료 (실제)

2019년 7월 12일

연구 등록 날짜

최초 제출

1999년 11월 1일

QC 기준을 충족하는 최초 제출

2003년 1월 26일

처음 게시됨 (추정)

2003년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 19일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • RP 98-15 (기타 식별자: Roswell Park Cancer Institute)

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