BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia
Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia that has not responded to treatment with cladribine.
PURPOSE: This phase II trial is studying BL22 immunotoxin to see how well it works in treating patients previously treated with cladribine for hairy cell leukemia.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin.
Secondary
- Determine the response duration in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients.
OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest.
Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR without minimal residual disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses beyond CR.
Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Maryland
-
Bethesda, Maryland, 미국, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed hairy cell leukemia
- CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody
Meets at least 1 of the following indications for treatment:
- Absolute neutrophil count less than 1,000/mm^3
- Hemoglobin less than 10 g/dL
- Platelet count less than 100,000/mm^3
- Absolute lymphocyte count greater than 20,000/mm^3
- Symptomatic splenomegaly
Meets 1 of the following response criteria:
- No response
- Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine
- CR or PR less than 4 years in duration after a second or later course of prior cladribine
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than 2.2 mg/dL
- Albumin at least 3.0 g/dL
Renal
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness that would preclude study participation
- Understand and give informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior BL22 immunotoxin
- More than 12 weeks since prior monoclonal antibody therapy
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior systemic cytotoxic chemotherapy
Endocrine therapy
- More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day)
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No other concurrent investigational agents
공부 계획
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: 1
BL22 immunotoxin
|
Dosing via IV on Days 1,3, and 5.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Response rate
기간: After even cycle numbers (2,4,6,8,10)
|
After even cycle numbers (2,4,6,8,10)
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]
기간: 30 days after last dose of study drug
|
30 days after last dose of study drug
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000341680
- NCI-04-C-0014
- NCI-6048
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. .
BL22에 대한 임상 시험
-
MedImmune LLCCambridge Antibody Technology정지된