Purpura, Thrombocytopenic, IdiopathicPhase 1/2NCT00547066
Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
A Phase 1/2 study testing veltuzumab in people with Purpura, Thrombocytopenic, Idiopathic and Autoimmune Thrombocytopenic Purpura, run by Gilead Sciences at 8 sites in United States.
Trial summary
This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Autoimmune
- What is being tested?
- veltuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2007to Nov 2011
- 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
- Male or female, >18 years old, with or without prior splenectomy
- Signed written informed consent obtained prior to study entry
- ITP according to ASH guidelines, with other potential causes of thrombocytopenia excluded
- Platelet levels < 150 x 109/L for more than 6 months
- Received an adequate course of at least one standard ITP treatment (an inadequate course of standard ITP therapy does not qualify as meeting this requirement)
- Platelet count < 30 x 109/L at study entry and on at least one other occasion at least 1 week apart within the past month. (Phase I only: platelet count also > 10 x 109/L at study entry).
- Bleeding assessment score of Grade 0 or 1. See full protocol for all inclusion criteria
Who cannot join
- See full protocol for exclusion criteria or contact study staff for details
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Hematology/Oncology Specialists
Buffalo, New York, 14215
Study site
Denville, New Jersey, 07834
Goshen Center for Cancer Care
Goshen, Indiana, 46526
University of Southern California- Keck School of Medicine
Los Angeles, California, 90033
Hematology Oncology Specialists
Metairie, Louisiana, 70006
New York Presbyterian Hospital Weill Cornell Medical Center
New York, New York, 10021
Center of Hope for Cancer and Blood Disorders
Riverdale, Georgia, 30274
Georgia Cancer Specialtists
Tucker, Georgia, 30084
About this study
Official title: A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura
This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.
Read the detailed description
The goal of current treatment guidelines for most patients with chronic adult ITP is to maintain platelet levels above 30 x 109/L. The conventional first-line therapy is corticosteroids with or without intravenous immunoglobulins, but many patients relapse when steroids are tapered. Standard therapy then is splenectomy, but patients with refractory ITP who do not respond require further therapy. Unfortunately, immunosuppressive agents or other available treatments typically produce only short-term responses. Because of the lack of medical options after first-line therapy, the target population for this first study of anti-CD20 immunotherapy with hA20 are adult patients with chronic ITP who failed at least one standard ITP therapy (i.e., received at least one standard ITP therapy and now present with platelet levels below 30 x 109/L).
In autoimmune disease, rituximab as well as other anti-CD20 antibodies currently being considered for commercialization have focused on a different dosing schedule in rheumatoid arthritis, and use fixed dosages rather than variable doses based on body surface area. In addition, recent studies of these newer anti-CD20 antibodies in rheumatoid arthritis have reported that lower doses indeed appear effective when administered twice, 2 weeks apart. Based upon these considerations, patients in this study will receive hA20 twice, 2 weeks apart, and administered at one of 3 dose levels.
- Conditions
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Autoimmune
- Being tested
- veltuzumab
- Keywords
- ITP, hA20, Treatment
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veltuzumabBiological
Also called IMMU-106, hA20, humanized anti-CD20
hA20 will be administered intravenously in two doses over two weeks
| Study group | Role | What they receive |
|---|---|---|
| veltuzumab | Experimental | veltuzumab is a humanized CD20 antibody administered subcutaneously. Receives: Biological: veltuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary - Safety
Hematology laboratory results and adverse events will be followed closely for one year.
Measured: 1 year
Secondary - Efficacy
Platelet responses will be followed for up to 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2011
- Study completionNov 2011
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 Purpura, Thrombocytopenic, IdiopathicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Wegener, MD, PHD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547066
- Sponsor's protocol ID
- IM-T-hA20-07
- Status last verified
- Mar 2020
- First submitted
- 17 Oct 2007
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Comparison of two dosing schedules for subcutaneous injections of low-dose anti-CD20 veltuzumab in relapsed immune thrombocytopenia. Haematologica. 2016 Nov;101(11):1327-1332. doi: 10.3324/haematol.2016.146738. Epub 2016 Aug 11.
PubMed 27515248Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study. Br J Haematol. 2013 Sep;162(5):693-701. doi: 10.1111/bjh.12448. Epub 2013 Jul 6.
PubMed 23829485
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00547066
- Acronym / sponsor ID
- IM-T-hA20-07
- Conditions
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Autoimmune
- Keywords
- ITP, hA20, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Oct 2007 (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 trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.
Detailed description
The goal of current treatment guidelines for most patients with chronic adult ITP is to maintain platelet levels above 30 x 109/L. The conventional first-line therapy is corticosteroids with or without intravenous immunoglobulins, but many patients relapse when steroids are tapered. Standard therapy then is splenectomy, but patients with refractory ITP who do not respond require further therapy. Unfortunately, immunosuppressive agents or other available treatments typically produce only short-term responses. Because of the lack of medical options after first-line therapy, the target population for this first study of anti-CD20 immunotherapy with hA20 are adult patients with chronic ITP who failed at least one standard ITP therapy (i.e., received at least one standard ITP therapy and now present with platelet levels below 30 x 109/L).
In autoimmune disease, rituximab as well as other anti-CD20 antibodies currently being considered for commercialization have focused on a different dosing schedule in rheumatoid arthritis, and use fixed dosages rather than variable doses based on body surface area. In addition, recent studies of these newer anti-CD20 antibodies in rheumatoid arthritis have reported that lower doses indeed appear effective when administered twice, 2 weeks apart. Based upon these considerations, patients in this study will receive hA20 twice, 2 weeks apart, and administered at one of 3 dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| veltuzumab | Experimental | Biological: veltuzumabveltuzumab is a humanized CD20 antibody administered subcutaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, >18 years old, with or without prior splenectomy
- Signed written informed consent obtained prior to study entry
- ITP according to ASH guidelines, with other potential causes of thrombocytopenia excluded
- Platelet levels < 150 x 109/L for more than 6 months
- Received an adequate course of at least one standard ITP treatment (an inadequate course of standard ITP therapy does not qualify as meeting this requirement)
Key exclusion criteria (1 listed)
- See full protocol for exclusion criteria or contact study staff for details
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 |
|---|---|---|
| veltuzumabAlso: IMMU-106, hA20, humanized anti-CD20hA20 will be administered intravenously in two doses over two weeks | Biological | veltuzumab |
Primary outcome
Primary - Safety
Time frame: 1 year
Hematology laboratory results and adverse events will be followed closely for one year.
Secondary - Efficacy
Time frame: 5 years
Platelet responses will be followed for up to 5 years.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 27515248Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Comparison of two dosing schedules for subcutaneous injections of low-dose anti-CD20 veltuzumab in relapsed immune thrombocytopenia. Haematologica. 2016 Nov;101(11):1327-1332. doi: 10.3324/haematol.2016.146738. Epub 2016 Aug 11.
- Derived from this study: PubMed 23829485Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study. Br J Haematol. 2013 Sep;162(5):693-701. doi: 10.1111/bjh.12448. Epub 2013 Jul 6.
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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
8 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 veltuzumab in people with Purpura, Thrombocytopenic, Idiopathic and Autoimmune Thrombocytopenic Purpura, run by Gilead Sciences at 8 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 7 inclusion and 1 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 16 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 8 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 was stopped early. 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?
Primary - Safety (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT00547066, 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 16 Aug 2021.