Chronic Lymphocytic LeukemiaPhase 1/2NCT00496132
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1/2 study testing PRO131921 in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc..
Trial summary
This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- PRO131921
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2007to 17 Jun 2009
- Phase
- Phase 1/2
- 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
- Documented history of histologically confirmed B-cell CLL
- Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen
- Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL
- For patients of reproductive potential (males and females), use of a reliable means of contraception
- For females of childbearing potential, a negative serum pregnancy test
Who cannot join
- Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
- Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment
- Current or recent CLL treatment
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL
- Use of hematopoietic growth factors or RBC and/or platelet transfusions
Show all 17Show fewer
- Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
- History of cancer other than CLL)
- Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics
- A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
- Positive hepatitis B or C serology
- Positive human immunodeficiency virus (HIV) serology
- Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing
- Pregnancy or lactation
- CNS leukemia
- Recent major surgery, other than diagnostic surgery
About this study
Official title: An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen
This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- PRO131921
- Keywords
- CLL, Leukemia, Lymph
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO131921Drug
Escalating doses by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PRO131921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities and adverse events
Measured: Length of study
Secondary outcomes (2)
Pharmacokinetic parameters; CD19-positive B-cell counts
Measured: Length of study
Overall response rate and progression-free survival (Phase II only)
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study start27 Aug 2007
- Primary completion17 Jun 2009
- Study completion17 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Ho, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496132
- Sponsor's protocol ID
- ACO4198g
- Status last verified
- Jun 2017
- First submitted
- 3 Jul 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen
- ClinicalTrials.gov ID
- NCT00496132
- Acronym / sponsor ID
- ACO4198g
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, Leukemia, Lymph
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2007 (actual)
- Primary completion
- 17 Jun 2009 (actual)
- Study completion
- 17 Jun 2009 (actual)
- First posted
- 4 Jul 2007 (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 is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PRO131921 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented history of histologically confirmed B-cell CLL
- Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen
- Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL
- For patients of reproductive potential (males and females), use of a reliable means of contraception
- For females of childbearing potential, a negative serum pregnancy test
Key exclusion criteria (17 listed)
- Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
- Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment
- Current or recent CLL treatment
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL
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 |
|---|---|---|
| PRO131921Escalating doses by IV infusion | Drug | 1 |
Primary outcome
Dose-limiting toxicities and adverse events
Time frame: Length of study
2 secondary outcomes
Pharmacokinetic parameters; CD19-positive B-cell counts
Time frame: Length of study
Overall response rate and progression-free survival (Phase II only)
Time frame: Length of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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.
Bill Ho, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRO131921 in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc..
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 was stopped early. Results are not available in the source record.
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?
Dose-limiting toxicities and adverse events (time frame: Length of study). 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 2 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.