Non-Hodgkin's LymphomaPhase 1/2NCT01851551
Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
A Phase 1/2 study testing Vincristine Sulfate Liposome Injection plus rituximab in people with Non-Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma, run by Acrotech Biopharma Inc. at 2 sites in 2 countries.
Trial summary
This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Vincristine Sulfate Liposome Injection plus rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2001to Apr 2005
- 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 diffuse large B-cell non-Hodgkin's lymphoma (NHL), as defined by the Revised European American Lymphoma/WHO classification. This included: diffuse large B-cell, primary mediastinal large B-cell lymphoma with sclerosis,intravascular large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell rich B-cell lymphoma or anaplastic large B-cell lymphoma. In the US protocol only, patients who had transformation from an indolent lymphoma and those who had mantle cell lymphoma were eligible.
- Confirmation of CD20 expression on lymphoma cells.
- Eastern Cooperative Oncology Group (ECOG) ≤2.
- One or more prior chemotherapy regimens. Patients who had received prior rituximab therapy as part of an induction chemotherapy regimen or who had a previous response to rituximab as a single agent were eligible.
- Measurable disease in at least 1 site, which had not been previously irradiated.
- Measurable disease was defined as at least 1 bidimensionally measurable lesion with clearly defined margins that were ≥1.5 cm in the largest dimension determined by physical examination or computed tomography (CT) scan.
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- Total bilirubin and serum creatinine ≤2 times the ULN.
- Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.
- 18 years of age or older.
- Women of childbearing potential who were willing to use an acceptable method of contraception throughout the course of the study.
- Signed and dated informed consent form.
Who cannot join
- Known transformation from an indolent lymphoma (UK protocol only).
- Eligible for conventional or high-dose chemotherapy with curative intent.
- Radiotherapy, chemotherapy, immunotherapy, or corticosteroids (>10 mg/day of prednisone or equivalent) within the past 4 weeks.
- Any previous malignancies with less than a 5-year complete remission interval, except for curatively resected basal cell carcinoma or curatively resected in situ carcinoma of the uterine cervix.
- History of or active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.
- History of neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
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- Grade 3 or 4 sensory or motor neuropathy at screening related to prior chemotherapy.
- Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
- Pregnant or lactating women (women of childbearing potential underwent a pregnancy test).
- Allergy to vincristine, or other vinca alkaloids.
- Progressive disease while receiving or within 1 month of having received previous rituximab therapy (US protocol only).
- Hypersensitivity to any component of rituximab or to murine proteins (UK protocol only).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California
San Francisco, California, 94110
United Kingdom1 site
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX
About this study
Official title: A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma
This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma.
Read the detailed description
The primary efficacy endpoint was objective response rate, defined as the proportion of patients with a response of CR + PR.
Duration of response, time to progression, and overall survival were analyzed. Descriptive statistics were used for demographics, disease characteristics, treatment exposures, efficacy, and safety variables.
- Being tested
- Vincristine Sulfate Liposome Injection plus rituximab
- Keywords
- NHL, non-Hodgkin's lymphoma, diffuse large b-cell lymphoma, mantle cell lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vincristine Sulfate Liposome Injection plus rituximabDrug
Also called Marqibo, VSLI, rituximab, rituxan
| Study group | Role | What they receive |
|---|---|---|
| VSLI plus rituximab | Experimental | VSLI (vincristine sulfate liposome injection) plus rituximab Receives: Drug: Vincristine Sulfate Liposome Injection plus rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The primary efficacy endpoint was the objective response rate (ORR) defined as the proportion of patients whose best responses were complete response (CR) and partial response (PR) (ORR = CR + PR).
Measured: Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks).
Secondary outcomes (3)
Assessment of the number of events and number and percentage of patients with treatment-emergent AEs
The number of events and number and percentage of patients with treatment-emergent AEs that occurred from the time of first study treatment up to 30 days following the last study treatment were summarized by MedDRA system organ class and preferred term, NCI CTC grade, and relationship to study drug.
Safety variables included adverse events, neurologic assessments, chemistry and hematology laboratory tests, physical examinations, and vital signs.
Neurologic symptom scores were summarized for baseline and worst score on study. The number and percentage of patients with neurologic symptom abnormalities were tabulated and presented by severity and cycle for each symptom.
Neurologic sign scores were summarized for baseline and worst score on study. The number and percentage of patients with neurologic sign abnormalities were tabulated and presented by severity and cycle for each sign.
Shifts from baseline to worst value were tabulated by cycle based on NCI CTC grades
Measured: AEs were assessed up to 30 days post last dose. Dosing may last up to 24 weeks.
Time to Progression
Time To Progression (TTP), defined as the interval between the initial day of dosing and disease progression or death due to NHL
Measured: First dose to disease progression. Follow up was reported approximately every 3 months post-dose up to the date of patient death. Patients were followed up to 2 yrs.
Overall survival
Overall Survival (OS) was defined as the interval between the initial day of dosing and death due to any cause.
Measured: The interval between first dose and death due to any cause. Reported every 3 months post dose up to patient death. Follow up was approximately 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 May 2013 (estimated)
- Study startSep 2001
- Primary completionApr 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Kaplan, MD, Principal investigator, University of California, San FranciscoGareth Morgan, Prof., Principal investigator, Leeds General Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851551
- Sponsor's protocol ID
- CA00005
- Status last verified
- Dec 2019
- First submitted
- 29 Apr 2013
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01851551
- Acronym / sponsor ID
- CA00005
- Keywords
- NHL, non-Hodgkin's lymphoma, diffuse large b-cell lymphoma, mantle cell lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 10 May 2013 (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 was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma.
Detailed description
The primary efficacy endpoint was objective response rate, defined as the proportion of patients with a response of CR + PR.
Duration of response, time to progression, and overall survival were analyzed. Descriptive statistics were used for demographics, disease characteristics, treatment exposures, efficacy, and safety variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSLI plus rituximab | Experimental | Drug: Vincristine Sulfate Liposome Injection plus rituximabVSLI (vincristine sulfate liposome injection) plus rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically-confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL), as defined by the Revised European American Lymphoma/WHO classification. This included: diffuse large B-cell, primary mediastinal large B-cell lymphoma with sclerosis,intravascular large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell rich B-cell lymphoma or anaplastic large B-cell lymphoma. In the US protocol only, patients who had transformation from an indolent lymphoma and those who had mantle cell lymphoma were eligible.
- Measurable disease was defined as at least 1 bidimensionally measurable lesion with clearly defined margins that were ≥1.5 cm in the largest dimension determined by physical examination or computed tomography (CT) scan.
- Total bilirubin and serum creatinine ≤2 times the ULN.
- Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.
- 18 years of age or older.
Key exclusion criteria (12 listed)
- Known transformation from an indolent lymphoma (UK protocol only).
- Eligible for conventional or high-dose chemotherapy with curative intent.
- Radiotherapy, chemotherapy, immunotherapy, or corticosteroids (>10 mg/day of prednisone or equivalent) within the past 4 weeks.
- Any previous malignancies with less than a 5-year complete remission interval, except for curatively resected basal cell carcinoma or curatively resected in situ carcinoma of the uterine cervix.
- History of or active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.
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 |
|---|---|---|
| Vincristine Sulfate Liposome Injection plus rituximabAlso: Marqibo, VSLI, rituximab, rituxan | Drug | VSLI plus rituximab |
Primary outcome
Objective response rate
Time frame: Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks).
The primary efficacy endpoint was the objective response rate (ORR) defined as the proportion of patients whose best responses were complete response (CR) and partial response (PR) (ORR = CR + PR).
3 secondary outcomes
Assessment of the number of events and number and percentage of patients with treatment-emergent AEs
Time frame: AEs were assessed up to 30 days post last dose. Dosing may last up to 24 weeks.
Time to Progression
Time frame: First dose to disease progression. Follow up was reported approximately every 3 months post-dose up to the date of patient death. Patients were followed up to 2 yrs.
Overall survival
Time frame: The interval between first dose and death due to any cause. Reported every 3 months post dose up to patient death. Follow up was approximately 2 years
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 3 Jan 2020.
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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.
Lawrence Kaplan, MD principal investigator
University of California, San Francisco
Gareth Morgan, Prof. principal investigator
Leeds General Infirmary
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vincristine Sulfate Liposome Injection plus rituximab in people with Non-Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma, run by Acrotech Biopharma Inc. at 2 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 11 inclusion and 12 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 3 Jan 2020. 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, United Kingdom. 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 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?
Objective response rate (time frame: Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks).). 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 3 Jan 2020.