LeukemiaPhase 1NCT00019032
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia
A Phase 1 study testing monoclonal antibody Mik-beta-1 in people with Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- monoclonal antibody Mik-beta-1
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1996to 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 T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support:
- Absolute neutrophil count less than 1,000/mm^3
- Hemoglobin less than 8 g/dL
- Platelet count less than 50,000/mm^3
- Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS
- Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- See Disease Characteristics
- No active major bleeding episode within the past 4 weeks
Hepatic:
- Direct bilirubin less than 1.5 mg/dL
Renal:
- Creatinine less than 2.0 mg/dL
Other:
- No concurrent serious active infection
- Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true:
- No pathogenic organism in culture
- Afebrile (maximum temperature less than 38°C) for at least 5 days
- HIV negative
- No other primary cancer other than basal cell skin cancer
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior interferon
- Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation
- No concurrent interferon
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 1 week since completion of prior antibiotic regimen for serious infectious episode
- No other concurrent investigational drugs
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 T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia, anemia, or thrombocytopenia.
- Determine the clinical response in patients treated with this drug.
- Assess the effect of this drug on the number of circulating CD3+, CD8+ expressing granular lymphocytes and the number of polymorphonuclear leukocytes, red blood cells, and platelets in this patient population.
- Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) IV over 2 hours on days 1, 4, 7, and 10. Patients achieving a complete response (CR) or partial response (PR) may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course, in the absence of antibodies to MOAB Mik-beta-1. Treatment continues in the absence of disease progression, unacceptable toxicity, or severe allergic reaction.
Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 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.
Patients are followed at 6-10 days and at 4-6 weeks after therapy. Patients with a PR or CR may be followed every 6 months for 2 years or until relapse. All patients are followed for survival.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- monoclonal antibody Mik-beta-1
- Keywords
- refractory chronic lymphocytic leukemia, T-cell large granular lymphocyte leukemia
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Large Granular Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monoclonal antibody Mik-beta-1Biological
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)
- Study startMar 1996
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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas A. Waldmann, MD, Study chair, NCI - Metabolism Branch;MET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019032
- Sponsor's protocol ID
- CDR0000064038
- Other IDs
- NCI-95-C-0054K
- Status last verified
- Apr 2004
- First submitted
- 11 Jul 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 T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT
- ClinicalTrials.gov ID
- NCT00019032
- Acronym / sponsor ID
- CDR0000064038
- Conditions
- Leukemia
- Keywords
- refractory chronic lymphocytic leukemia, T-cell large granular lymphocyte leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 1996
- 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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
- Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia, anemia, or thrombocytopenia.
- Determine the clinical response in patients treated with this drug.
- Assess the effect of this drug on the number of circulating CD3+, CD8+ expressing granular lymphocytes and the number of polymorphonuclear leukocytes, red blood cells, and platelets in this patient population.
- Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) IV over 2 hours on days 1, 4, 7, and 10. Patients achieving a complete response (CR) or partial response (PR) may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course, in the absence of antibodies to MOAB Mik-beta-1. Treatment continues in the absence of disease progression, unacceptable toxicity, or severe allergic reaction.
Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 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.
Patients are followed at 6-10 days and at 4-6 weeks after therapy. Patients with a PR or CR may be followed every 6 months for 2 years or until relapse. All patients are followed for survival.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
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 |
|---|---|---|
| monoclonal antibody Mik-beta-1 | Biological | – |
Primary outcome
Not reported in the source record.
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 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.
Thomas A. Waldmann, MD study chair
NCI - Metabolism Branch;MET
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 monoclonal antibody Mik-beta-1 in people with Leukemia, 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: finished, 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 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.
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.