Noncontiguous Stage II Small Lymphocytic LymphomaPhase 2NCT00089154
Apolizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study testing apolizumab, laboratory biomarker analysis and pharmacological study in people with Noncontiguous Stage II Small Lymphocytic Lymphoma and Recurrent Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
- What is being tested?
- apolizumab, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Oct 2005
- 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
Who may be able to join
- Histologically confirmed hematologic malignancy of 1 of the following histologies:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Noncontiguous stage II or stage III or IV disease
- Received >= 1 form of prior immunotherapy or chemotherapy
- Completed therapy at least 4 weeks ago
Show all 36Show fewer
- Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:
- Progressively worsening disease (symptoms increasing in severity by 1 toxicity criterion over a period of >= 2 weeks)
- Progressively worsening anemia or thrombocytopenia
- Progressively worsening lymphadenopathy
- Massive splenomegaly or hypersplenism
- Hyperlymphocytosis (WBC > 200,000/mm^3) OR lymphocyte doubling time < 12 months
- Marrow failure due to marrow infiltration by leukemia or lymphoma
- Leukemia cells must express 1D10 antigen > 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells
- Performance status - ECOG 0-2
- At least 2 years
- Platelet count >= 50,000/mm^3 (transfusion independent)
- Bilirubin =< 3 mg/dL (unless due to tumor involvement)
- Creatinine =< 2.0 mg/dL
- No decompensated congestive heart failure
- No unstable angina
- No myocardial infarction within the past 6 months not corrected by surgery or percutaneous transluminal coronary angioplasty
- No active infection requiring oral or IV antibiotics
- No other malignancy that limits life expectancy to < 2 years or that requires active anticancer therapy within 4 weeks of study entry
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study treatment
- Recovered from prior immunotherapy
- More than 3 months since prior alemtuzumab or rituximab
- No prior apolizumab
- Recovered from prior chemotherapy
- More than 4 weeks since prior anticancer hormonal therapy
- More than 4 weeks since prior anticancer radiotherapy
- More than 4 weeks since prior anticancer surgery
- At least 4 weeks since other prior therapy for CLL or SLL and recovered
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University Medical Center
Columbus, Ohio, 43210
Chronic Lymphocytic Leukemia Research Consortium (CRC)
La Jolla, California, 92093-0820
About this study
Official title: A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab.
II. Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients.
SECONDARY OBJECTIVES:
- Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed.
III. To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy.
IV. To determine the cellular properties which convey resistance to apolizumab in CLL in vivo.
OUTLINE: This is a multicenter study.
Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then every 6 months for 3 years.
- Conditions
- Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Stage III Small Lymphocytic Lymphoma, Stage IV Small Lymphocytic Lymphoma
- Being tested
- apolizumab, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apolizumabBiological
Also called 1D1O Anti-lymphoma Antibody, MOAB 1D10, MoAb Hu1D10, Monoclonal antibody 1D10
Given IV
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (apolizumab) | Experimental | Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity. Receives: Biological: apolizumab; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (CR+PR)
Measured: Up to 3 years
Progression-free survival rate
Measured: Up to 3 years
Frequency and severity of treatment-related adverse events
Measured: Up to 30 days
Secondary outcomes (1)
Pharmacokinetic clearance
Measured: Days 1, 2, 3, 5, 8, 15, 22, 26, 27, 29 and 1, 2, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startAug 2004
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noncontiguous Stage II Small Lymphocytic LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Byrd, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089154
- Sponsor's protocol ID
- NCI-2012-01454
- Other IDs
- OSU 0410, CLLRC-OSU-0410, CDR0000378072, OSU-0410, NCI-6257, R21CA091564
- Status last verified
- Jun 2013
- First submitted
- 4 Aug 2004
- Last updated
- 16 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
- ClinicalTrials.gov ID
- NCT00089154
- Acronym / sponsor ID
- NCI-2012-01454
- Conditions
- Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Stage III Small Lymphocytic Lymphoma, Stage IV Small Lymphocytic Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2004
- Primary completion
- Oct 2005 (actual)
- First posted
- 5 Aug 2004 (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.
This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab.
II. Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients.
SECONDARY OBJECTIVES:
- Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed.
III. To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy.
IV. To determine the cellular properties which convey resistance to apolizumab in CLL in vivo.
OUTLINE: This is a multicenter study.
Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (apolizumab) | Experimental | Biological: apolizumab, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Histologically confirmed hematologic malignancy of 1 of the following histologies:
- Received >= 1 form of prior immunotherapy or chemotherapy
- Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:
- Leukemia cells must express 1D10 antigen > 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells
- Performance status - ECOG 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| apolizumabAlso: 1D1O Anti-lymphoma Antibody, MOAB 1D10, MoAb Hu1D10, Monoclonal antibody 1D10Given IV | Biological | Treatment (apolizumab) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (apolizumab) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (apolizumab) |
Primary outcome
Response rate (CR+PR)
Time frame: Up to 3 years
Progression-free survival rate
Time frame: Up to 3 years
Frequency and severity of treatment-related adverse events
Time frame: Up to 30 days
1 secondary outcome
Pharmacokinetic clearance
Time frame: Days 1, 2, 3, 5, 8, 15, 22, 26, 27, 29 and 1, 2, 3, and 6 months
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 16 Jul 2013.
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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.
John Byrd principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apolizumab, laboratory biomarker analysis and pharmacological study in people with Noncontiguous Stage II Small Lymphocytic Lymphoma and Recurrent Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 2 sites 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?
The sponsor lists 36 inclusion and 0 exclusion criteria. 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 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (CR+PR) (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 16 Jul 2013.