LeukemiaPhase 1NCT00058396
Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 1 study testing lumiliximab in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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 relapsed or refractory chronic lymphocytic leukemia or… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- lumiliximab
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Oct 2004
- 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 small lymphocytic lymphoma
- Stage III-IV OR
- Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics:
- Rapid doubling of peripheral lymphocyte count
- Progressive lymphadenopathy
- Progressive splenomegaly
- B symptoms
- Grade 2 or 3 fatigue
- CD23+ disease
- Progressive disease after at least 1 prior chemotherapy course
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Platelet count at least 50,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST/ALT no greater than 1.5 times upper limit of normal (ULN)
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- No myocardial infarction within the past 6 months
- No unstable arrhythmia
- No evidence of ischemia on EKG within the past 14 days
Pulmonary
- FEV_1 at least 60% of predicted
- DLCO at least 55% of predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study treatment
- HIV negative
- No secondary malignancy requiring active treatment (except hormonal therapy)
- No serious nonmalignant disease that would preclude study participation
- No active uncontrolled bacterial, viral, or fungal infection
- No clinically active autoimmune disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior anticancer biologic therapy
- More than 4 weeks since prior anticancer radioimmunotherapy
- No prior exposure to IDEC-152 or anti-CD23 antibodies
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior anticancer chemotherapy
Endocrine therapy
- Concurrent hormonal therapy allowed for second malignancy
Radiotherapy
- More than 4 weeks since prior anticancer radiotherapy
Surgery
- More than 4 weeks since prior major surgery (except for diagnostic surgery)
Other
- More than 4 weeks since prior anticancer investigational therapy
- No other concurrent anticancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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 relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Read the detailed description
OBJECTIVES:
- Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the efficacy of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22.
Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.
- Being tested
- lumiliximab
- Keywords
- refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, noncontiguous stage II small lymphocytic lymphoma, recurrent small lymphocytic lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumiliximabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startOct 2002
- Primary completionOct 2004
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 Memorial Sloan Kettering Cancer CenterThe 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark Adam Weiss, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058396
- Sponsor's protocol ID
- IDEC-152-20
- Other IDs
- MSKCC-02096, CDR0000288828
- Status last verified
- Dec 2009
- First submitted
- 7 Apr 2003
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00058396
- Acronym / sponsor ID
- IDEC-152-20
- Keywords
- refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, noncontiguous stage II small lymphocytic lymphoma, recurrent small lymphocytic lymphoma, stage I small lymphocytic lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- Primary completion
- Oct 2004 (actual)
- First posted
- 9 Apr 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 tumor cells and either kill them or deliver tumor-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 relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed description
OBJECTIVES:
- Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the efficacy of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22.
Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| lumiliximab | 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 30 May 2013.
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.
Mark Adam Weiss, MD study chair
Memorial Sloan Kettering Cancer Center
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 lumiliximab in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center 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 30 May 2013. 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 30 May 2013.