Lymphoma, Non-HodgkinPhase 1NCT01555853
Phase I/II Study of Abraxane in Recurrent and Refractory Lymphoma
A Phase 1 study testing Abraxane in people with Lymphoma, Non-Hodgkin and Hodgkin Disease, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Hodgkin Disease
- What is being tested?
- Abraxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Jun 2016
- 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
- Patient must have histologically confirmed B-cell non-Hodgkin lymphoma or classical Hodgkin lymphoma:
- Diffuse large B-cell lymphoma (including transformed large cell lymphoma and primary mediastinal B cell lymphoma)
- Mantle cell lymphoma
- Burkitt's lymphoma
- Follicular lymphoma
- Small lymphocytic lymphoma
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- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
- Classical Hodgkin lymphoma (including nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte deplete)
- Patient must have measurable disease, defined as the presence of ≥ 1 lymph node or tumor mass measuring ≥ 1 cm in a single dimension as assessed by CT or MRI.
- Patient must have had prior treatment with ≥ 2 chemotherapy or chemo-immunotherapy regimens. Prior autologous stem cell transplant is allowed, and prior allogeneic stem cell transplant is allowed as long as the patient has recovered from acute toxicities and is off immunosuppression without evidence of graft versus host disease (GVHD).
- Patient must be ≥ 18 years of age.
- Patient must have an ECOG performance status ≤ 2.
- Patient must have adequate bone marrow reserve at the time of therapy initiation, defined as ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
- Patient must have adequate hepatic function, defined as total bilirubin ≤ 1.5 x ULN and AST/ALT ≤ 3 x ULN.
- Patient must have adequate renal function, defined as serum creatinine ≤ 2.0 x ULN.
- Patient must have recovered from any acute toxicities associated with prior therapy to ≤ grade 1.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patient (or legally authorized representative, if applicable) must be able to understand and willing to sign an IRB approved written informed consent document.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patient must not have nodular lymphocyte predominant Hodgkin lymphoma subtype.
- Patient must not have a history of a non-lymphoma malignancy except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, localized prostate cancer, any adequately treated stage I or stage II cancer currently in complete remission, or any other cancer in complete remission for at least 5 years.
- Patient must not be receiving any other investigational agents, and must not have taken any other investigational agents within ≤ 3 weeks of study entry chemotherapy, immunotherapy, radiotherapy, and/or investigational agents while on study.
- Patients with Hodgkin's lymphoma must not otherwise be eligible for treatment with brentuximab vedotin.
- Patient must not have central nervous system or leptomeningeal lymphoma.
- Patient must not have with history of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane.
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- Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient must not be pregnant and/or breastfeeding.
- Patient must not be known to be HIV-positive.
- Patient must not have any pre-existing peripheral neuropathy > grade 1.
- Patient must not have received any chemotherapy, immunotherapy, and/or investigational agents and/or radiotherapy < 3 weeks prior to starting study drug.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Louis University School of Medicine
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma
This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well tolerated therapies are needed to treat patients with relapsed and refractory lymphomas. Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and may be an effective treatment for lymphoma.
- Conditions
- Lymphoma, Non-Hodgkin, Hodgkin Disease
- Being tested
- Abraxane
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Also called ABI-007
| Study group | Role | What they receive |
|---|---|---|
| Phase I-Dose Level 0 | Experimental | Abraxane 100 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. Receives: Drug: Abraxane |
| Phase I-Dose Level 1 | Experimental | Abraxane 125 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. Receives: Drug: Abraxane |
| Phase I-Dose Level 2 | Experimental | Abraxane 150 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. Receives: Drug: Abraxane |
| Phase II | Experimental | Abraxane (dose to be determined in Phase I) IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. Receives: Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Measured: 28 days (completion of cycle 1) for all patients in Phase I portion
Phase I: Dose-limiting toxicities (DLTs) of Abraxane in patients with recurrent or refractory lymphoma
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4
Measured: 28 days (completion of cycle 1)
Phase II: Overall response rate (CR + PR)
Measured: 24 weeks (end of study)
Secondary outcomes (5)
Phase I: Toxicity associated with Abraxane
Measured: 28 weeks (30 days after completion of study treatment)
Phase II: Time to progression.
Response and progression will be recorded with each imaging evaluation according to the 2007 revised response criteria for malignant lymphoma by Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86.
Measured: 24 weeks (end of study)
Phase II: Duration of remission
Measured: 24 weeks (end of study)
Phase II: Overall survival.
Measured: 3 years
Phase II: Clinical benefit (CR + PR + SD)
Measured: 24 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: completed accrual to phase I but drug did not show activity, so halted before initiation of phase II
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Bartlett, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555853
- Sponsor's protocol ID
- 201204071
- Status last verified
- Dec 2016
- First submitted
- 13 Mar 2012
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT01555853
- Acronym / sponsor ID
- 201204071
- Conditions
- Lymphoma, Non-Hodgkin, Hodgkin Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: completed accrual to phase I but drug did not show activity, so halted before initiation of phase II
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Mar 2012 (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 studies the side effects, maximum tolerated dose, and effectiveness of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well tolerated therapies are needed to treat patients with relapsed and refractory lymphomas. Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and may be an effective treatment for lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I-Dose Level 0 | Experimental | Drug: AbraxaneAbraxane 100 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. |
| Phase I-Dose Level 1 | Experimental | Drug: AbraxaneAbraxane 125 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. |
| Phase I-Dose Level 2 | Experimental | Drug: AbraxaneAbraxane 150 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. |
| Phase II | Experimental | Drug: AbraxaneAbraxane (dose to be determined in Phase I) IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must have histologically confirmed B-cell non-Hodgkin lymphoma or classical Hodgkin lymphoma:
- Patient must have measurable disease, defined as the presence of ≥ 1 lymph node or tumor mass measuring ≥ 1 cm in a single dimension as assessed by CT or MRI.
- Patient must have had prior treatment with ≥ 2 chemotherapy or chemo-immunotherapy regimens. Prior autologous stem cell transplant is allowed, and prior allogeneic stem cell transplant is allowed as long as the patient has recovered from acute toxicities and is off immunosuppression without evidence of graft versus host disease (GVHD).
- Patient must be ≥ 18 years of age.
- Patient must have an ECOG performance status ≤ 2.
Key exclusion criteria (11 listed)
- Patient must not have nodular lymphocyte predominant Hodgkin lymphoma subtype.
- Patient must not have a history of a non-lymphoma malignancy except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, localized prostate cancer, any adequately treated stage I or stage II cancer currently in complete remission, or any other cancer in complete remission for at least 5 years.
- Patient must not be receiving any other investigational agents, and must not have taken any other investigational agents within ≤ 3 weeks of study entry chemotherapy, immunotherapy, radiotherapy, and/or investigational agents while on study.
- Patients with Hodgkin's lymphoma must not otherwise be eligible for treatment with brentuximab vedotin.
- Patient must not have central nervous system or leptomeningeal lymphoma.
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 |
|---|---|---|
| AbraxaneAlso: ABI-007 | Drug | Phase I-Dose Level 0, Phase I-Dose Level 1, Phase I-Dose Level 2, Phase II |
Primary outcome
Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma
Time frame: 28 days (completion of cycle 1) for all patients in Phase I portion
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Phase I: Dose-limiting toxicities (DLTs) of Abraxane in patients with recurrent or refractory lymphoma
Time frame: 28 days (completion of cycle 1)
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4
Phase II: Overall response rate (CR + PR)
Time frame: 24 weeks (end of study)
5 secondary outcomes
Phase I: Toxicity associated with Abraxane
Time frame: 28 weeks (30 days after completion of study treatment)
Phase II: Time to progression.
Time frame: 24 weeks (end of study)
Phase II: Duration of remission
Time frame: 24 weeks (end of study)
Phase II: Overall survival.
Time frame: 3 years
Phase II: Clinical benefit (CR + PR + SD)
Time frame: 24 weeks (end of study)
Results and safety
The study was stopped early (reason given: completed accrual to phase I but drug did not show activity, so halted before initiation of phase II). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Nancy Bartlett, M.D. principal investigator
Washington University School of Medicine
2 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 Abraxane in people with Lymphoma, Non-Hodgkin and Hodgkin Disease, run by Washington University School of Medicine 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 20 inclusion and 11 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 6 Dec 2016. 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 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 was stopped early (reason given: completed accrual to phase I but drug did not show activity, so halted before initiation of phase II). 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?
Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma (time frame: 28 days (completion of cycle 1) for all patients in Phase I portion). 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 6 Dec 2016.