LeukemiaPhase 2NCT00074048
BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia
A Phase 2 study testing BL22 in people with Leukemia, run by MedImmune LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- BL22
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Leukemia
- Being tested
- BL22
- Keywords
- refractory hairy cell leukemia
- Medical subject headings
- Leukemia, Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL22Drug
Dosing via IV on Days 1,3, and 5.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BL22 immunotoxin Receives: Drug: BL22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: After even cycle numbers (2,4,6,8,10)
Secondary outcomes (1)
Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]
Measured: 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startOct 2003
- Primary completionApr 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Kreitman, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074048
- Sponsor's protocol ID
- CDR0000341680
- Other IDs
- NCI-04-C-0014, NCI-6048
- Status last verified
- Jun 2010
- First submitted
- 10 Dec 2003
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.
PubMed 18596230
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
- ClinicalTrials.gov ID
- NCT00074048
- Acronym / sponsor ID
- CDR0000341680
- Conditions
- Leukemia
- Keywords
- refractory hairy cell leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BL22BL22 immunotoxin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL22Dosing via IV on Days 1,3, and 5. | Drug | 1 |
Primary outcome
Response rate
Time frame: After even cycle numbers (2,4,6,8,10)
1 secondary outcome
Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]
Time frame: 30 days after last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 18596230Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.
- Web site for additional informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kreitman, MD study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL22 in people with Leukemia, run by MedImmune LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: After even cycle numbers (2,4,6,8,10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.