CD20-Positive Lymphoid MalignanciesPhase 1NCT00788684
Safety Study of ABT-263 in Combination With Rituximab in Lymphoid Cancers
A Phase 1 study testing rituximab and ABT-263 in people with CD20-Positive Lymphoid Malignancies and Chronic Lymphoid Leukemia, run by AbbVie at 6 sites in 2 countries.
Trial summary
This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in participants with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active participants to continue to receive ABT-263 for up to 14 years after the last participant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD20-Positive Lymphoid Malignancies, Chronic Lymphoid Leukemia, Hematological Malignancies
- What is being tested?
- rituximab and ABT-263
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Jul 2009to 7 Feb 2025
- 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
- Diagnosed with a CD20-positive lymphoproliferative disorder (Revised European American Lymphoma [REAL]/World Health Organization [WHO]) and bi-dimensionally measurable disease with at least 1 lesion >= 1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance score of <= 1
- Adequate bone marrow function, independent of growth factor support (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve Absolute Neutrophil count (ANC) eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) >= 1000/μL; Platelets >= 100,000/mm3 (untransfused); Hemoglobin >= 9.0 g/dL.
- Participants who have a history of autologous stem cell transplant (e.g., bone marrow) must be > 6 months post transplant and have adequate bone marrow function, independent of any growth stimulating factors (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve ANC eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) >= 1500/μL; Platelets >= 125,000/mm3 (untransfused); Hemoglobin >= 10.0 g/dL.
- Participant must have adequate renal, hepatic and coagulation function per local laboratory reference range as follows: Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min; AST and ALT <= 3.0 × the upper normal limit (ULN); Bilirubin <= 1.5 × ULN. Participants with Gilbert's Syndrome may have a Bilirubin > 1.5 × ULN; activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 × ULN
- Females must be surgically sterile, postmenopausal (at least 1 year), or have negative pregnancy test at screening on serum sample obtained within 14 days prior to initial study drug administration, and prior to dosing on a urine obtained on Lead-in Day 1, if it has been > 7 days since obtaining the serum pregnancy test results. Females not surgically sterile or postmenopausal (at least 1 year) and non-vasectomized males must practice at least 1 of the following: total abstinence from sexual intercourse (minimum 1 complete menstrual cycle),a vasectomized partner, hormonal contraceptives for at least 3 months prior to study drug administration, or double-barrier method.
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- Inclusion Criteria (Extension Study) Participants who enter the Extension Study must continue to meet all Inclusion and Exclusion criteria, with the exception of inclusion criteria regarding measurable disease and inclusion criteria regarding laboratory parameters. Participants entering the Extension Study must also have stable lab values per local laboratory reference ranges. In addition they must meet the following lab criteria:
- Participants must meet the following hematology and coagulation lab criteria:
- Platelet counts must be >= 25,000/mm3 (untransfused). Platelet counts <= 50,000/mm3 must be stable and monitored at an increased frequency at the discretion of the investigator.
- Absolute Neutrophil count (ANC) >= 500/μL. ANC >= 500/μL and < 1,000/μL should be monitored at an increased frequency at the discretion of the investigator.
- Hemoglobin of >= 8.0 g/dL.
- aPTT, PT is not to exceed 1.2 × ULN.
- Participants' chemistry values must not exceed Grade 2. Grade 2 chemistry labs should be monitored at an increased frequency at the discretion of the investigator. Participants must meet the following chemistry criteria:
- Serum creatinine <= 3.0 × the upper normal limit (ULN) of institution's normal range.
- AST and ALT <= 5.0 × the upper normal limit (ULN) of institution's normal range.
- Bilirubin <= 3 × ULN. Participants with Gilbert's Syndrome may be allowed to have a Bilirubin > 3 × ULN based on a joint decision between the investigator and AbbVie medical monitor.
Who cannot join
- History of or clinically suspicious for cancer-related Central Nervous System (CNS) disease, allogeneic stem cell transplant, recurrent significant infections, previous or current malignancies within the last 5 years (except: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent), toxicity from rituximab that resulted in permanent discontinuation of treatment or toxicity from ABT-263 or another Bcl-2 family protein inhibitor, significant cardiovascular disease (e.g., MI within 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic or hepatic disease that would adversely affect participation, severe (defined as Grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies
- The participant has an underlying, predisposing condition of bleeding or currently exhibits signs of clinically significant bleeding. The participanthas a recent history of non-chemotherapy induced thrombocytopenic associated bleeding within six months prior to the first dose of study drug. The participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis or active immune thrombocytopenic purpura (ITP) or a history of being refractory to platelet transfusions (within six months prior to the first dose of study drug).
- Female participant is pregnant or breast-feeding
- Participant has tested positive for HIV, Hepatitis B or Hepatitis C infection, (Participants who test positive for anti-HBc (carrier) will be allowed to enroll)
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration
- Received steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug,received aspirin within seven days prior to the first dose of study drug, CYP3A inhibitors (e.g., ketoconazole, clarithromycin) within 7 days prior to the administration of the first dose of study drug, radio-immunotherapy within six months prior to first dose of study drug,received any anti-cancer therapy within fourteen days prior to the first dose of study drug.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Cleveland Clinic Main Campus /ID# 9784
Cleveland, Ohio, 44195
Univ of Wisconsin Hosp/Clinics /ID# 21701
Madison, Wisconsin, 53792-0001
Stanford University School of Med /ID# 9782
Stanford, California, 94305-2200
University of Arizona Cancer Center - North Campus /ID# 16721
Tucson, Arizona, 85719-1478
Australia2 sites
Peter MacCallum Cancer Ctr /ID# 25067
Melbourne, Victoria, 3000
The Royal Melbourne Hospital /ID# 9781
Parkville, Victoria, 3050
About this study
Official title: A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Rituximab in Subjects With CD20-positive Lymphoid Malignancies
This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in participants with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active participants to continue to receive ABT-263 for up to 14 years after the last participant transitions with quarterly study evaluations.
- Conditions
- CD20-Positive Lymphoid Malignancies, Chronic Lymphoid Leukemia, Hematological Malignancies, Non-Hodgkin's Lymphoma
- Being tested
- rituximab, ABT-263
- Keywords
- Non-Hodgkin's Lymphoma, Rituximab, Chronic Lymphoid Leukemia, Hematological Malignancies, ABT-263, Navitoclax, CD20-Positive Lymphoid Malignancies
- Medical subject headings
- Leukemia, B-Cell, Hematologic Neoplasms, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called Rituxan
IV infusion once weekly for four doses
ABT-263Drug
Also called navitoclax
ABT-263: oral solution or tablets, once daily dosing until disease progression
| Study group | Role | What they receive |
|---|---|---|
| ABT-263 + rituximab | Experimental | Not described Receives: Drug: rituximab; Drug: ABT-263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension Study: Continued assessment of the safety profile of ABT-263 when administered in combination with rituximab
Measured: Safety will be assessed until the participant discontinues the extension portion of the study.
Assess the safety profile and characterize the pharmacokinetics of ABT-263 when administered in combination with rituximab
Measured: Safety and pharmacokinetics will be assessed until the participant discontinues the study or transitions to the extension portion of the study (whichever comes first).
Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) when ABT-263 is administered in combination with rituximab
Measured: DLTs and MTD will be assessed after all participants in a dose level have completed the lead-in period plus 28 days if dosing with ABT-263 and rituximab
Secondary outcomes (2)
Extension Study: Continued assessment of the preliminary progression-free survival (PFS), response rate, and duration of response.
Measured: PFS will be measured upon study completion via statistical analysis of the study data.
Preliminary progression-free survival (PFS), response rate, and duration of response.
Measured: PFS will be measured upon study completion via statistical analysis of the study data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study start21 Jul 2009
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD20-Positive Lymphoid MalignanciesStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788684
- Sponsor's protocol ID
- M10-166
- Status last verified
- Feb 2025
- First submitted
- 10 Nov 2008
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. 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 Rituximab in Subjects With CD20-positive Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00788684
- Acronym / sponsor ID
- M10-166
- Conditions
- CD20-Positive Lymphoid Malignancies, Chronic Lymphoid Leukemia, Hematological Malignancies, Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Rituximab, Chronic Lymphoid Leukemia, Hematological Malignancies, ABT-263, Navitoclax, CD20-Positive Lymphoid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- 21 Jul 2009 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 11 Nov 2008 (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 rituximab in participants with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active participants to continue to receive ABT-263 for up to 14 years after the last participant transitions with quarterly study evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-263 + rituximab | Experimental | Drug: rituximab, Drug: ABT-263 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosed with a CD20-positive lymphoproliferative disorder (Revised European American Lymphoma [REAL]/World Health Organization [WHO]) and bi-dimensionally measurable disease with at least 1 lesion >= 1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance score of <= 1
- Adequate bone marrow function, independent of growth factor support (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve Absolute Neutrophil count (ANC) eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) >= 1000/μL; Platelets >= 100,000/mm3 (untransfused); Hemoglobin >= 9.0 g/dL.
- Participants who have a history of autologous stem cell transplant (e.g., bone marrow) must be > 6 months post transplant and have adequate bone marrow function, independent of any growth stimulating factors (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve ANC eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) >= 1500/μL; Platelets >= 125,000/mm3 (untransfused); Hemoglobin >= 10.0 g/dL.
- Participant must have adequate renal, hepatic and coagulation function per local laboratory reference range as follows: Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min; AST and ALT <= 3.0 × the upper normal limit (ULN); Bilirubin <= 1.5 × ULN. Participants with Gilbert's Syndrome may have a Bilirubin > 1.5 × ULN; activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 × ULN
Key exclusion criteria (6 listed)
- History of or clinically suspicious for cancer-related Central Nervous System (CNS) disease, allogeneic stem cell transplant, recurrent significant infections, previous or current malignancies within the last 5 years (except: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent), toxicity from rituximab that resulted in permanent discontinuation of treatment or toxicity from ABT-263 or another Bcl-2 family protein inhibitor, significant cardiovascular disease (e.g., MI within 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic or hepatic disease that would adversely affect participation, severe (defined as Grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies
- The participant has an underlying, predisposing condition of bleeding or currently exhibits signs of clinically significant bleeding. The participanthas a recent history of non-chemotherapy induced thrombocytopenic associated bleeding within six months prior to the first dose of study drug. The participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis or active immune thrombocytopenic purpura (ITP) or a history of being refractory to platelet transfusions (within six months prior to the first dose of study drug).
- Female participant is pregnant or breast-feeding
- Participant has tested positive for HIV, Hepatitis B or Hepatitis C infection, (Participants who test positive for anti-HBc (carrier) will be allowed to enroll)
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration
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 |
|---|---|---|
| rituximabAlso: RituxanIV infusion once weekly for four doses | Drug | ABT-263 + rituximab |
| ABT-263Also: navitoclaxABT-263: oral solution or tablets, once daily dosing until disease progression | Drug | ABT-263 + rituximab |
Primary outcome
Extension Study: Continued assessment of the safety profile of ABT-263 when administered in combination with rituximab
Time frame: Safety will be assessed until the participant discontinues the extension portion of the study.
Assess the safety profile and characterize the pharmacokinetics of ABT-263 when administered in combination with rituximab
Time frame: Safety and pharmacokinetics will be assessed until the participant discontinues the study or transitions to the extension portion of the study (whichever comes first).
Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) when ABT-263 is administered in combination with rituximab
Time frame: DLTs and MTD will be assessed after all participants in a dose level have completed the lead-in period plus 28 days if dosing with ABT-263 and rituximab
2 secondary outcomes
Extension Study: Continued assessment of the preliminary progression-free survival (PFS), response rate, and duration of response.
Time frame: PFS will be measured upon study completion via statistical analysis of the study data.
Preliminary progression-free survival (PFS), response rate, and duration of response.
Time frame: PFS will be measured upon study completion via statistical analysis of the study data.
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 20 Feb 2025.
- Individual participant dataSharing planned: No
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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.
ABBVIE INC. study director
AbbVie
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rituximab and ABT-263 in people with CD20-Positive Lymphoid Malignancies and Chronic Lymphoid Leukemia, run by AbbVie at 6 sites in 2 countries.
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 16 inclusion and 6 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 20 Feb 2025. 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, Australia. 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?
Extension Study: Continued assessment of the safety profile of ABT-263 when administered in combination with rituximab (time frame: Safety will be assessed until the participant discontinues the extension portion of the study.). 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 20 Feb 2025.