- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00074048
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
BL22 immunotoxin
|
Dosing via IV on Days 1,3, and 5.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Response rate
Tidsramme: After even cycle numbers (2,4,6,8,10)
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After even cycle numbers (2,4,6,8,10)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]
Tidsramme: 30 days after last dose of study drug
|
30 days after last dose of study drug
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000341680
- NCI-04-C-0014
- NCI-6048
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Kliniske forsøg med BL22
-
National Cancer Institute (NCI)AfsluttetHårcelleleukæmiForenede Stater
-
National Cancer Institute (NCI)Afsluttet
-
MedImmune LLCAfsluttet
-
MedImmune LLCCambridge Antibody TechnologySuspenderetLymfom | LeukæmiForenede Stater
-
National Cancer Institute (NCI)Trukket tilbageBL22 immuntoksin til behandling af patienter med non-Hodgkins lymfom eller kronisk lymfatisk leukæmiLymfom | LeukæmiForenede Stater