LeukemiaPhase 1NCT00024115
BL22 Immunotoxin in Treating Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1 study testing BL22 immunotoxin, antibody therapy and biological response modifier therapy in people with Leukemia and Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- BL22 immunotoxin, antibody therapy and biological response modifier therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 chronic lymphocytic leukemia or prolymphocytic leukemia:
- Failed prior standard chemotherapy and treatment is medically indicated as evidenced by the following:
- Progressive disease-related symptoms
- Progressive cytopenias due to marrow involvement
- Progressive or painful splenomegaly or adenopathy
- Rapidly increasing lymphocytosis
- Autoimmune hemolytic anemia or thrombocytopenia
- Increased frequency of infections OR
- Confirmed CD22+ B-cell indolent non-Hodgkin's lymphoma
- Stages II-IV that have failed at least 1 prior standard therapy and treatment is medically indicated
- No patients whose serum neutralizes BL22 or PE38 in tissue culture, due to antitoxin or antimouse-IgG antibodies
- No central nervous system disease requiring treatment
- If the patient is non-leukemic, the absolute neutrophil count must be greater than 1,000/mm3 and the platelet count greater than 40,000/mm3
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 6 months
Hematopoietic:
- See Disease Characteristics
Hepatic:
- ALT and AST less than 5 times upper limit of normal
Renal:
- Adequate renal function
Pulmonary:
- Adequate pulmonary function
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior bone marrow transplantation allowed
- At least 3 weeks since prior interferon for malignancy
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior cytotoxic chemotherapy for malignancy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy for malignancy
Surgery:
- Not specified
Other:
- At least 3 weeks since prior retinoids
- At least 3 weeks since prior systemic therapy for cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Determine the pharmacokinetics, including the terminal elimination serum half-life area under the curve and volume of distribution, of recombinant BL22 immunotoxin in these patients.
- Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.
- Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
- Being tested
- BL22 immunotoxin, antibody therapy, biological response modifier therapy, immunotoxin therapy
- Keywords
- refractory chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, stage III grade I follicular small cleaved cell lymphoma, stage III grade II follicular mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV grade I follicular small cleaved cell lymphoma, stage IV grade II follicular mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, recurrent grade I follicular small cleaved cell lymphoma, recurrent grade II follicular mixed cell lymphoma, recurrent grade III follicular large cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma, prolymphocytic leukemia, contiguous stage II grade I follicular small cleaved cell lymphoma, contiguous stage II grade II follicular mixed cell lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL22 immunotoxinDrug
antibody therapyProcedure or surgery
biological response modifier therapyProcedure or surgery
immunotoxin therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert Kreitman, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024115
- Sponsor's protocol ID
- CDR0000068892
- Other IDs
- NCI-01-C-0213, NCI-5336
- Status last verified
- Dec 2006
- First submitted
- 13 Sep 2001
- Last updated
- 28 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00024115
- Acronym / sponsor ID
- CDR0000068892
- Keywords
- refractory chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, stage III grade I follicular small cleaved cell lymphoma, stage III grade II follicular mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV grade I follicular small cleaved cell lymphoma, stage IV grade II follicular mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- First posted
- 27 Jan 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.
PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
- Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Determine the pharmacokinetics, including the terminal elimination serum half-life area under the curve and volume of distribution, of recombinant BL22 immunotoxin in these patients.
- Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.
- Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| BL22 immunotoxin | Drug | – |
| antibody therapy | Procedure or surgery | – |
| biological response modifier therapy | Procedure or surgery | – |
| immunotoxin therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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 1 study testing BL22 immunotoxin, antibody therapy and biological response modifier therapy in people with Leukemia and Lymphoma, run by National Cancer Institute (NCI) 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: withdrawn, as of the sponsor's last update on 28 Apr 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 28 Apr 2015.