Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia (LLC-LENAR-08)
Phase I Study of the Activity and Safety of Lenalidomide and Rituximab as Non-chemotherapy Therapy for Patients With Recurrent and Refractory Chronic Lymphocytic Leukemia
The rationale for combining lenalidomide with rituximab derives from preclinical observations suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular cytotoxicity) triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK cytotoxicity by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These results provide the cellular and molecular basis for the use of lenalidomide as an adjuvant in immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The combination lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on CLL cell lines. However the observed synergism was attributed to NK cells expansion, thus lending support to the notion that this synergism may operate in other B-cell lymphoproliferative malignancies.
The objective was to develop a non-cytotoxic and effective treatment for CLL that would fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and frail. These patients experience an excess in chemotherapy induced toxicity, often preventing the completion of the planned treatment.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Córdoba, 스페인, 14004
- Hospital Universitario Reina Sofia
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28033
- MD Anderson Internacional España
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Salamanca, 스페인, 37007
- Hospital Clínico de Salamanca
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Sevilla, 스페인, 41013
- Hospital Virgen del Rocío
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Valencia, 스페인, 46010
- Hospital Clinico Universitario de Valencia
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Zaragoza, 스페인, 50009
- Hospital Universitario Miguel Servet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Recurrent and refractory CLL patients that have received at least one previous treatment with purine analogs.
- Adequate liver function and renal function.
- ECOG performance status ≤ 2.
- Signed informed consent
- Male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy.
Exclusion Criteria:
- Positive serological markers for hepatitis B with the exception of HBsAc in previously vaccinated patients
- Pregnant patients
- HIV infection
- Concurrent chemotherapy or immunotherapy
- Other malignancy within the last 2 years, except for localized cutaneous carcinoma
- Neurological impairment precluding understanding of protocol and the entailed visits and procedures.
- Patients with Renal insufficiency that requires dialysis.
공부 계획
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 |
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실험적: Lenalidomida, Rituximab
Phase I: Lenalidomide will be administered from day 1 to 21 of 28 days cycles, escalating doses (from 2,5mg to 25 mg).Rituximab dose will be administered at the standard (375 mg/m2 in the first cycle and 500 mg/m2 in successive cycles).
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Lenalidomide: Oral use. It will be administered from day 1 to 21 of 28 days cycles in a total of 6 cycles. Rituximab, intravenous use. The dose will be administered at the standard (375 mg/m2 in the first cycle and 500 mg/m2 in successive cycles). In the first cycle Rituximab will be administered in two divided doses:100mg/m2 total on day 1 and the rest up to 375mg/m2 on day 2. If lenalidomide treatment starts on day 1, Rituximab will be administered, in this first cycle, on days -2 (100 mg/m2) and -1 (275 mg/m2). In the second and subsequent cycles, 500 mg/m2 of Rituximab will be administered on day -1.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Phase I: To determine Starting Recommended Dose for the first cycle and the subsequent cycles (Maximal Tolerated Dose)in relapsed B-cell CLL patients.
기간: 5 months
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6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression.
Module I: patients on every cohort will have the same dose during treatment, except if they experiment DLT, in which case dose will be decreased (unless they are on the first dose level).
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5 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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To determine the toxicity profile of LenRtx.
기간: 5 months
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Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
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5 months
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To determine the time to treatment failure.
기간: 5 months
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Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
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5 months
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To determine the molecular response rate.
기간: 5 months
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Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
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5 months
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To determine the clinical response rate (combined morphological and flow cytometry criteria).
기간: 5 months
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6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression
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5 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: José F Tomas, MD, MD Anderson Internacional España
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LLC-LENAR-08 (기타 식별자: Fundación MD Anderson Internacional. España)
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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