Idiopathic Thrombocytopenic Purpura (ITP)Phase 2NCT00161564
A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone
A Phase 2 study testing Rituximab in people with Idiopathic Thrombocytopenic Purpura (ITP), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura (ITP)
- What is being tested?
- Rituximab
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to not given
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will be eligible to participate in the study if they:
- Have chronic ITP19 (> 6 months duration).
- Have received Rituximab a minimum of 3 months prior to entry.
- Have received no more than 2 courses of Rituximab at standard dose separated by a minimum of 12 weeks.
- Have not achieved a durable response to Rituximab, with platelet counts < 30,000/ml when not supported by other treatment.
- Have a platelet count of < 30,000/ul on two separate occasions 1-2 weeks apart within the past month prior to the inclusion.
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- Are age ≥ 12 years old.
- Had a splenectomy at least 60 days prior to study entry, or a contraindication to splenectomy.
- Give written informed consent.
- Use an effective means of contraception during treatment and for six months after completion of treatment.
- Have negative serum pregnancy test, for all women who are able to have children, within 14 days prior to study entry.
Who cannot join
- Male and female subjects will be ineligible to participate if they:
- Received prior treatment with cyclophosphamide within the last 3 months.
- Received prior treatment with > 4 infusions of vinca alkaloids within the 6 months.
- Had previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.
- Have an HIV infection.
- Have hepatitis Bs antigen positivity or active hepatitis C infection
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- Have an absolute neutrophil count < 1.000/mm3 at study entry (unless related to autoimmune neutropenia).
- Have a Hemoglobin level < 10 g/dl other than caused by thalassemia trait, iron deficiency or autoimmune hemolytic anemia (patients with Evan's syndrome will not be excluded).
- Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL.
- Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an AST or ALT level > 3x upper limit of normal.
- Have active infection requiring antibiotic therapy within 7 days prior to study entry.
- Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug.
- Have had a prior severe reaction to Rituximab, leading to discontinuation of treatment.
- Have a New York Heart Classification III or IV heart disease.
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University Division of Pediatric Hematology-Oncology
New York, New York, 10021
About this study
Official title: A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment
The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard doses of rituximab.
Read the detailed description
Primary Objectives
- Efficacy: The primary objective (primary endpoint) is to determine the rate of response (partial or complete response) at week 16 (± 2) post-treatment in both pilot arms: the high dose Rituximab (or HDR) group (750 mg/m2 x 4) and the group treated with a regimen combining standard doses of Rituximab with CVP (R-CVP.) A complete response (CR) will be a platelet count increase ³ 150,000/mL on two consecutive occasions one week apart, without any other therapy. A partial response will be considered if the platelet count increases between 50 and 150,000/mL.
- Safety: To assess and compare the incidence of moderate and severe adverse-events including the number and type of infections in both arms of the study using Genentech standard safety monitoring and serious adverse event (SAE) reporting.
Secondary Objectives
- To compare the response rate in the 2 treatment arms in the "Rituximab non-responders" sub group (see 4.1 for definition)
- To compare the response rate in the 2 treatment arms in the " Rituximab relapsers" subgroup
- To assess the mean duration of response (PR or CR) in the 2 treatment arms.
- To evaluate the duration of very low to absent peripheral blood B cells in the two treatment arms.
- To assess the incidence of hypogammaglobulinemia (IgG and/or IgM level < ½ of lower limit of normal for age) and white blood counts in the two arms.
- Being tested
- Rituximab
- Keywords
- Idiopathic Thrombocytopenic Purpura, ITP, Non-Malignant Hematology
- 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.
RituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic Purpura (ITP)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- James B Bussel, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161564
- Sponsor's protocol ID
- U2735S
- Status last verified
- Jul 2018
- First submitted
- 8 Sep 2005
- Last updated
- 17 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment
- ClinicalTrials.gov ID
- NCT00161564
- Acronym / sponsor ID
- U2735S
- Keywords
- Idiopathic Thrombocytopenic Purpura, ITP, Non-Malignant Hematology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2004
- First posted
- 12 Sep 2005 (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.
The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard doses of rituximab.
Detailed description
Primary Objectives
- Efficacy: The primary objective (primary endpoint) is to determine the rate of response (partial or complete response) at week 16 (± 2) post-treatment in both pilot arms: the high dose Rituximab (or HDR) group (750 mg/m2 x 4) and the group treated with a regimen combining standard doses of Rituximab with CVP (R-CVP.) A complete response (CR) will be a platelet count increase ³ 150,000/mL on two consecutive occasions one week apart, without any other therapy. A partial response will be considered if the platelet count increases between 50 and 150,000/mL.
- Safety: To assess and compare the incidence of moderate and severe adverse-events including the number and type of infections in both arms of the study using Genentech standard safety monitoring and serious adverse event (SAE) reporting.
Secondary Objectives
- To compare the response rate in the 2 treatment arms in the "Rituximab non-responders" sub group (see 4.1 for definition)
- To compare the response rate in the 2 treatment arms in the " Rituximab relapsers" subgroup
- To assess the mean duration of response (PR or CR) in the 2 treatment arms.
- To evaluate the duration of very low to absent peripheral blood B cells in the two treatment arms.
- To assess the incidence of hypogammaglobulinemia (IgG and/or IgM level < ½ of lower limit of normal for age) and white blood counts in the two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Have chronic ITP19 (> 6 months duration).
- Have received Rituximab a minimum of 3 months prior to entry.
- Have received no more than 2 courses of Rituximab at standard dose separated by a minimum of 12 weeks.
- Have not achieved a durable response to Rituximab, with platelet counts < 30,000/ml when not supported by other treatment.
- Have a platelet count of < 30,000/ul on two separate occasions 1-2 weeks apart within the past month prior to the inclusion.
Key exclusion criteria (15 listed)
- Received prior treatment with cyclophosphamide within the last 3 months.
- Received prior treatment with > 4 infusions of vinca alkaloids within the 6 months.
- Had previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.
- Have an HIV infection.
- Have hepatitis Bs antigen positivity or active hepatitis C 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 |
|---|---|---|
| Rituximab | Drug | – |
Primary outcome
Not reported in the source record.
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 17 Jul 2018.
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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.
James B Bussel, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Idiopathic Thrombocytopenic Purpura (ITP), run by Weill Medical College of Cornell University 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 11 inclusion and 15 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 17 Jul 2018. 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 phase mean?
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.
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 17 Jul 2018.