Non-Hodgkin's LymphomaPhase 1/2NCT00285428
Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
A Phase 1/2 study testing hA20-humanized anti-CD20 antibody in people with Non-Hodgkin's Lymphoma, run by Gilead Sciences at 3 sites in United States.
Trial summary
This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- hA20-humanized anti-CD20 antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2004to Oct 2007
- 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
- CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MD Anderson Cancer Center
Houston, Texas, 77030
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, 10021
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma
This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- hA20-humanized anti-CD20 antibody
- Keywords
- treatment, NHL, CD20+ B-cell NHL, Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hA20-humanized anti-CD20 antibodyDrug
Also called veltuzumab, IMMU-106, hA20
once weekly iv dosing for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | 120 mg/m2 Receives: Drug: hA20-humanized anti-CD20 antibody |
| Dose level 2 | Experimental | 200 mg/m2 Receives: Drug: hA20-humanized anti-CD20 antibody |
| Dose Level 3 | Experimental | 375 mg/m2 Receives: Drug: hA20-humanized anti-CD20 antibody |
| Dose level 1B | Experimental | 80 mg/m2 Receives: Drug: hA20-humanized anti-CD20 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance of different dose levels
Measured: 12 weeks
Secondary outcomes (4)
Lack of immunogenicity
Measured: 8 and 12 weeks
Pharmacodynamics
Measured: over 12 weeks
Pharmacokinetics
Measured: over 12 weeks
Efficacy
Measured: 4, 8 and 12 wks, every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startSep 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Wegener, MD, PhD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285428
- Sponsor's protocol ID
- IM-T-hA20-01
- Status last verified
- Feb 2012
- First submitted
- 31 Jan 2006
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.
PubMed 20214444Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.
PubMed 19451441
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00285428
- Acronym / sponsor ID
- IM-T-hA20-01
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- treatment, NHL, CD20+ B-cell NHL, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Feb 2006 (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 I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: hA20-humanized anti-CD20 antibody120 mg/m2 |
| Dose level 2 | Experimental | Drug: hA20-humanized anti-CD20 antibody200 mg/m2 |
| Dose Level 3 | Experimental | Drug: hA20-humanized anti-CD20 antibody375 mg/m2 |
| Dose level 1B | Experimental | Drug: hA20-humanized anti-CD20 antibody80 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease
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 |
|---|---|---|
| hA20-humanized anti-CD20 antibodyAlso: veltuzumab, IMMU-106, hA20once weekly iv dosing for 4 weeks | Drug | Dose Level 3, Dose level 1, Dose level 1B, Dose level 2 |
Primary outcome
Safety and tolerance of different dose levels
Time frame: 12 weeks
4 secondary outcomes
Lack of immunogenicity
Time frame: 8 and 12 weeks
Pharmacodynamics
Time frame: over 12 weeks
Pharmacokinetics
Time frame: over 12 weeks
Efficacy
Time frame: 4, 8 and 12 wks, every 3 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 17 Aug 2021.
- Background: PubMed 20214444Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.
- Results publication: PubMed 19451441Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.
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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.
William Wegener, MD, PhD study chair
Gilead Sciences
3 sites 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 hA20-humanized anti-CD20 antibody in people with Non-Hodgkin's Lymphoma, run by Gilead Sciences at 3 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 1 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: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Safety and tolerance of different dose levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00285428, which also lists 2 linked publications.
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 17 Aug 2021.