Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissuePhase 1/2NCT01238146
Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 1/2 study testing bendamustine hydrochloride, obatoclax mesylate and rituximab in people with Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate when given together with rituximab and bendamustine hydrochloride to see how well it works compared with rituximab and bendamustine hydrochloride alone in treating patients with relapsed or refractory non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma
- What is being tested?
- bendamustine hydrochloride, obatoclax mesylate and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2012
- 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
- Histologically confirmed indolent B-cell non-Hodgkin lymphoma (NHL), including any of the following subtypes recognized by WHO classification:
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Transformed lymphoma from a low-grade, indolent NHL allowed provided patient has received ≥ 1 prior therapy for indolent disease
Show all 37Show fewer
- Must have received ≥ 1 prior therapy
- Relapsed disease after autologous or allogeneic stem cell transplantation (SCT) allowed (phase I)
- No relapse after allogeneic SCT (phase II)
- No known CNS lymphoma
- ECOG performance status 0-2
- ANC ≥ 1,000/µL
- Platelet count ≥ 50,000/µL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception prior to and for the duration of study participation
- No active hepatitis B infection
- Patients with a history of hepatitis B (surface antigen or core antibody positive) must take lamivudine or equivalent during study therapy
- No history of documented human anti-globulin antibodies, or a history of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine hydrochloride, or obatoclax mesylate
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness and/or social situations that would limit compliance with study requirements
- HIV infection allowed provided patient meets the following criteria:
- No evidence of co-infection with hepatitis B or C
- CD4 cell count ≥ 400/mm³
- No evidence of resistant strains of HIV
- HIV viral load ≤ 10,000 copies HIV RNA/mL for patients not on anti-HIV combination antiretroviral therapy OR HIV viral load ≤ 50,000 copies HIV RNA/mL for patients on anti-HIV therapy
- No history of AIDS-defining conditions
- No active secondary malignancy except for non-melanomatous skin cancer
- No other concurrent investigational agents
- Prior bendamustine hydrochloride allowed provided patient has completed a bendamustine-containing regimen within the past 6 months and achieved a partial response or better
- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Phase I/II Trial of Rituximab, Bendamustine, and Obatoclax in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate when given together with rituximab and bendamustine hydrochloride to see how well it works compared with rituximab and bendamustine hydrochloride alone in treating patients with relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with rituximab and bendamustine hydrochloride may kill more cancer cells
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of the combination of obatoclax mesylate, rituximab, and bendamustine hydrochloride in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma (phase I).
II. To define the qualitative and quantitative toxicities of the combination of obatoclax mesylate, rituximab, and bendamustine (phase I).
III. To detect an improvement in median progression-free survival (PFS) from 6 to 12 months with the addition of obatoclax mesylate to rituximab and bendamustine hydrochloride in patients with indolent B-cell non-Hodgkin lymphoma (phase II).
SECONDARY OBJECTIVES:
- To determine the overall objective response rate to the combination of obatoclax mesylate, rituximab, and bendamustine versus rituximab and bendamustine hydrochloride in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma.
II. To characterize two-year PFS of patients with indolent B-cell non-Hodgkin lymphoma receiving obatoclax mesylate, rituximab, and bendamustine hydrochloride versus rituximab and bendamustine hydrochloride.
III. To assess the pharmacokinetics of obatoclax mesylate in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma.
IV. To assess the pharmacokinetics of the combination of bendamustine hydrochloride and obatoclax mesylate in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma.
- To determine the effects of the combination of rituximab, bendamustine hydrochloride, and obatoclax mesylate on histone-oligodeoxynucleotide (ODNA) and levels of activated Bax and Bak pro-apoptotic proteins in peripheral blood mononuclear cells and bone marrow aspirate specimens.
VI. To identify associations of genetic polymorphisms in drug-metabolizing enzymes, transporters, or target genes with pharmacokinetics, pharmacodynamics, or clinical outcomes.
OUTLINE: This is a phase I, dose-escalation study of obatoclax mesylate followed by a randomized phase II study.
PHASE I: Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1 (day 3 of course 1), and bendamustine hydrochloride IV over 30 minutes on day 1-2 (day 2-3 of course 1). Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are stratified according to prior bendamustine hydrochloride (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1, and bendamustine hydrochloride IV over 30 minutes on days 1-2.
ARM II: Patients receive rituximab and bendamustine hydrochloride as in arm I.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and bone marrow sample collection at baseline and periodically during study for pharmacokinetics, pharmacodynamic, and pharmacogenetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
- Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma
- Being tested
- bendamustine hydrochloride, obatoclax mesylate, rituximab
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustine hydrochlorideDrug
Also called bendamustin hydrochloride, bendamustine, cytostasan hydrochloride, Treanda
Given IV
obatoclax mesylateDrug
Also called GX15-070MS
Given IV
rituximabBiological
Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1, and bendamustine hydrochloride IV over 30 minutes on days 1-2. Receives: Drug: bendamustine hydrochloride; Drug: obatoclax mesylate; Biological: rituximab |
| Arm II | Experimental | Patients receive rituximab and bendamustine hydrochloride as in arm I. Receives: Drug: bendamustine hydrochloride; Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose, defined as the dose level beneath which 2 or more of 6 patients experience DLT (phase I)
Graded using CTCAE version 4 criteria. DLTs are defined as grade 3-4 neutropenia or thrombocytopenia that persists beyond day 42; grade 4 febrile neutropenia or infection; grade 3 febrile neutropenia or infection that fails to resolve within 7days, grade 3-4 somnolence, ataxia, or confusion that requires inpatient admission on day 1 for observation and prevents patient discharge from outpatient clinic, or other grade 3-4 non-hematologic toxicity excluding infection.
Measured: 28 days
Change in median progression-free survival (PFS) (phase II)
Estimated using the method of Kaplan-Meier.
Measured: From 6 to 12 months
Secondary outcomes (2)
Overall objective response rate (phase II)
95% confidence intervals will be provided.
Measured: Up to 3 years
PFS (phase II)
Estimated using the method of Kaplan-Meier.
Measured: From the date of start of therapy to disease progression or death, whichever occurs first, assessed at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2012
Why it stopped: No patients accrued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth Christian, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238146
- Sponsor's protocol ID
- NCI-2011-02536
- Other IDs
- OSU-10040, U01CA076576, CDR0000687197
- Status last verified
- Jun 2013
- First submitted
- 9 Nov 2010
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Rituximab, Bendamustine, and Obatoclax in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01238146
- Acronym / sponsor ID
- NCI-2011-02536
- Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients accrued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- First posted
- 10 Nov 2010 (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 I/II trial is studying the side effects and the best dose of obatoclax mesylate when given together with rituximab and bendamustine hydrochloride to see how well it works compared with rituximab and bendamustine hydrochloride alone in treating patients with relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with rituximab and bendamustine hydrochloride may kill more cancer cells
Detailed description
PRIMARY OBJECTIVES:
- To determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of the combination of obatoclax mesylate, rituximab, and bendamustine hydrochloride in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma (phase I).
II. To define the qualitative and quantitative toxicities of the combination of obatoclax mesylate, rituximab, and bendamustine (phase I).
III. To detect an improvement in median progression-free survival (PFS) from 6 to 12 months with the addition of obatoclax mesylate to rituximab and bendamustine hydrochloride in patients with indolent B-cell non-Hodgkin lymphoma (phase II).
SECONDARY OBJECTIVES:
- To determine the overall objective response rate to the combination of obatoclax mesylate, rituximab, and bendamustine versus rituximab and bendamustine hydrochloride in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma.
II. To characterize two-year PFS of patients with indolent B-cell non-Hodgkin lymphoma receiving obatoclax mesylate, rituximab, and bendamustine hydrochloride versus rituximab and bendamustine hydrochloride.
III. To assess the pharmacokinetics of obatoclax mesylate in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma.
IV. To assess the pharmacokinetics of the combination of bendamustine hydrochloride and obatoclax mesylate in patients with relapsed or refractory, indolent, B-cell non-Hodgkin lymphoma.
- To determine the effects of the combination of rituximab, bendamustine hydrochloride, and obatoclax mesylate on histone-oligodeoxynucleotide (ODNA) and levels of activated Bax and Bak pro-apoptotic proteins in peripheral blood mononuclear cells and bone marrow aspirate specimens.
VI. To identify associations of genetic polymorphisms in drug-metabolizing enzymes, transporters, or target genes with pharmacokinetics, pharmacodynamics, or clinical outcomes.
OUTLINE: This is a phase I, dose-escalation study of obatoclax mesylate followed by a randomized phase II study.
PHASE I: Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1 (day 3 of course 1), and bendamustine hydrochloride IV over 30 minutes on day 1-2 (day 2-3 of course 1). Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are stratified according to prior bendamustine hydrochloride (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1, and bendamustine hydrochloride IV over 30 minutes on days 1-2.
ARM II: Patients receive rituximab and bendamustine hydrochloride as in arm I.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and bone marrow sample collection at baseline and periodically during study for pharmacokinetics, pharmacodynamic, and pharmacogenetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: bendamustine hydrochloride, Drug: obatoclax mesylate, Biological: rituximabPatients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1, and bendamustine hydrochloride IV over 30 minutes on days 1-2. |
| Arm II | Experimental | Drug: bendamustine hydrochloride, Biological: rituximabPatients receive rituximab and bendamustine hydrochloride as in arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Histologically confirmed indolent B-cell non-Hodgkin lymphoma (NHL), including any of the following subtypes recognized by WHO classification:
- Transformed lymphoma from a low-grade, indolent NHL allowed provided patient has received ≥ 1 prior therapy for indolent disease
- Must have received ≥ 1 prior therapy
- Relapsed disease after autologous or allogeneic stem cell transplantation (SCT) allowed (phase I)
- No known CNS lymphoma
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 |
|---|---|---|
| bendamustine hydrochlorideAlso: bendamustin hydrochloride, bendamustine, cytostasan hydrochloride, TreandaGiven IV | Drug | Arm I, Arm II |
| obatoclax mesylateAlso: GX15-070MSGiven IV | Drug | Arm I |
| rituximabAlso: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8Given IV | Biological | Arm I, Arm II |
Primary outcome
Maximum tolerable dose, defined as the dose level beneath which 2 or more of 6 patients experience DLT (phase I)
Time frame: 28 days
Graded using CTCAE version 4 criteria. DLTs are defined as grade 3-4 neutropenia or thrombocytopenia that persists beyond day 42; grade 4 febrile neutropenia or infection; grade 3 febrile neutropenia or infection that fails to resolve within 7days, grade 3-4 somnolence, ataxia, or confusion that requires inpatient admission on day 1 for observation and prevents patient discharge from outpatient clinic, or other grade 3-4 non-hematologic toxicity excluding infection.
Change in median progression-free survival (PFS) (phase II)
Time frame: From 6 to 12 months
Estimated using the method of Kaplan-Meier.
2 secondary outcomes
Overall objective response rate (phase II)
Time frame: Up to 3 years
PFS (phase II)
Time frame: From the date of start of therapy to disease progression or death, whichever occurs first, assessed at 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Elizabeth Christian principal investigator
Ohio State University Comprehensive 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 1/2 study testing bendamustine hydrochloride, obatoclax mesylate and rituximab in people with Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma, run by National Cancer Institute (NCI) 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?
The sponsor lists 37 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: withdrawn, as of the sponsor's last update on 6 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 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 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 withdrawn before enrolling participants, so there are no results.
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?
Maximum tolerable dose, defined as the dose level beneath which 2 or more of 6 patients experience DLT (phase I) (time frame: 28 days). The study lists 2 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 6 Jun 2013.