Chronic Lymphocytic LeukemiaPhase 1NCT00868413
Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1 study testing ABT-263, FCR and BR in people with Chronic Lymphocytic Leukemia, run by AbbVie (prior sponsor, Abbott) at 6 sites in United States.
Trial summary
This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia. 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?
- ABT-263, FCR and BR
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2009to May 2013
- 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
Who may be able to join
- Must have relapsed or refractory Chronic Lymphocytic Leukemia (CLL), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR);
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of </=1;
- Must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve Absolute Neutrophil Count (ANC) eligibility criteria), per local laboratory reference range at Screening as follows: ANC >/=1000/mcL, Platelets>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening),Hemoglobin >/= 9.0 g/dL.
Who cannot join
- Subject has history or is clinically suspicious for cancer-related Central Nervous System disease;
- Has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
- Has undergone an allogeneic stem cell transplant; Exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
- Has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; Has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
- Currently receiving or requires anticoagulation therapy;
- Has active immune thrombocytopenic purpura (ITP) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
- Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Site Reference ID/Investigator# 21622
Baltimore, Maryland, 21231-1000
Site Reference ID/Investigator# 21621
Columbus, Ohio, 43210
Site Reference ID/Investigator# 17943
Houston, Texas, 77030-4009
Site Reference ID/Investigator# 17841
La Jolla, California, 92093
Site Reference ID/Investigator# 39613
Philadelphia, Pennsylvania, 19111
Site Reference ID/Investigator# 25899
Stanford, California, 94305-5821
About this study
Official title: A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- ABT-263, FCR, BR
- 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.
ABT-263Drug
ABT-263 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
FCRDrug
Also called fludarabine, cyclophosphamide, rituximab
Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle; Fludarabine will be given by intravenous infusion for 3 days out of each 28 day cycle; and Cyclophosphamide will be given by intravenous infusion for 3 days out of each 28 day cycle
BRDrug
Also called bendamustine, rituximab
Rituximab will be given by intravenous infusion for 2 days out of each 28 day cycle and Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | FCR+ABT-263 Receives: Drug: ABT-263; Drug: FCR |
| B | Active comparator | BR+ABT-263 Receives: Drug: ABT-263; Drug: BR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL.
Measured: Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days
Secondary outcomes (1)
Evaluate preliminary data regarding progression-free survival (PFS), tumor response rate and overall survival (OS) when ABT-263 is administered in combination with either FCR or BR.
Tumor assessments
Measured: Every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionMay 2013
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.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Sari Enschede, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868413
- Sponsor's protocol ID
- M10-458
- Status last verified
- May 2013
- First submitted
- 20 Mar 2009
- Last updated
- 7 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00868413
- Acronym / sponsor ID
- M10-458
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Mar 2009 (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 a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ABT-263, Drug: FCRFCR+ABT-263 |
| B | Active comparator | Drug: ABT-263, Drug: BRBR+ABT-263 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have relapsed or refractory Chronic Lymphocytic Leukemia (CLL), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR);
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of </=1;
- Must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve Absolute Neutrophil Count (ANC) eligibility criteria), per local laboratory reference range at Screening as follows: ANC >/=1000/mcL, Platelets>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening),Hemoglobin >/= 9.0 g/dL.
Key exclusion criteria (7 listed)
- Subject has history or is clinically suspicious for cancer-related Central Nervous System disease;
- Has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
- Has undergone an allogeneic stem cell transplant; Exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
- Has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; Has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
- Currently receiving or requires anticoagulation therapy;
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 |
|---|---|---|
| ABT-263ABT-263 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study. | Drug | A, B |
| FCRAlso: fludarabine, cyclophosphamide, rituximabRituximab will be given by intravenous infusion for 1 day out of each 28 day cycle; Fludarabine will be given by intravenous infusion for 3 days out of each 28 day cycle; and Cyclophosphamide will be given by intravenous infusion for 3 days out of each 28 day cycle | Drug | A |
| BRAlso: bendamustine, rituximabRituximab will be given by intravenous infusion for 2 days out of each 28 day cycle and Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle | Drug | B |
Primary outcome
Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL.
Time frame: Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days
1 secondary outcome
Evaluate preliminary data regarding progression-free survival (PFS), tumor response rate and overall survival (OS) when ABT-263 is administered in combination with either FCR or BR.
Time frame: Every 2 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 7 Jun 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.
Sari Enschede, MD study director
AbbVie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-263, FCR and BR in people with Chronic Lymphocytic Leukemia, run by AbbVie (prior sponsor, Abbott) at 6 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 3 inclusion and 7 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 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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.
What does the primary outcome measure?
Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL. (time frame: Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days). 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 7 Jun 2013.