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Immune ThrombocytopeniaPhase 2NCT03304288

The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

A Phase 2 study testing Rituximab and All-trans retinoic acid in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immune Thrombocytopenia
What is being tested?
Rituximab and All-trans retinoic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
4 sitesChina
Study dates
11 Oct 2017to 28 Feb 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ITP confirmed by excluding other supervened causes of thrombocytopenia;
  • Platelet count of less than 30×10^9/L at enrollment;
  • Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
  • ECOG<2.

Who cannot join

  • Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
  • Congestive heart failure
  • Severe arrhythmia
  • Nursing or pregnant women
  • Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria
  • Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
Show all 9Show fewer
  • Active or previous malignancy
  • Patients with other diseases were undergoing treatment with immunosuppressants
  • Patients with ITP had received rituximab

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Peking University Insititute of Hematology, Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Navy General Hospital

    Beijing, Beijing Municipality, 100048

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: The Combination of Low-dose Rituximab and All-trans Retinoic Acid as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: a Multicenter, Randomized, Open-label Trial

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.

Read the detailed description

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+ATRA and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Interim analysis was scheduled at 50% through recruitment. Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.

Being tested
Rituximab, All-trans retinoic acid
Keywords
all-trans retinoid acid, rituximab, steroid-resistant, refractory, low-dose
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

    Low-dose rituximab was used in combination with ATRA or as the monotherapy

  • All-trans retinoic acidDrug

    ATRA was used in combination with low-dose rituximab

Study groups in NCT03304288
Study groupRoleWhat they receive
low-dose rituximab & ATRAExperimentalrituximab 100mg once weekly for 6 weeks and oral all-trance retinoid acid 20mg/m^2 qd for 12 weeks.
Receives: Drug: Rituximab; Drug: All-trans retinoic acid
low-dose rituximabActive comparatorrituximab 100mg once weekly for 6 weeks
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response

    The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count >=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up. Interim analysis was scheduled at 50% through recruitment.

    Measured: From the start of study treatment (Day 1) up to the end of Year 1

  2. sustained response

    The number of participants that can maintain the platelet count > 30 x 109/L, an absence of bleeding events, and without requirement for any other ITP-specific treatment for 6 consecutive months after achievement of response. Interim analysis was scheduled at 50% through recruitment.

    Measured: From the start of study treatment (Day 1) up to the end of Year 1

Secondary outcomes (5)

  1. complete response

    The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up. Interim analysis was scheduled at 50% through recruitment.

    Measured: From the start of study treatment (Day 1) up to the end of Year 1

  2. time to response

    Time to response was defined as the time from starting treatment to the time to achieve the response. Interim analysis was scheduled at 50% through recruitment.

    Measured: From the start of study treatment (Day 1) up to the end of Year 1

  3. duration of response

    Duration of response was measured from the achievement of response to the loss of response. Interim analysis was scheduled at 50% through recruitment.

    Measured: From the start of study treatment (Day 1) up to the end of Year 1

  4. incidence of adverse events

    All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Interim analysis was scheduled at 50% through recruitment.

    Measured: From the start of study treatment (Day 1) up to the end of Year 1

  5. Initial response

    The number of patients who achieve response at 4 weeks following treatment

    Measured: From the start of study treatment (Day 1) up to the end of Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2017
  2. Study start11 Oct 2017
  3. Primary completion15 Jan 2021
  4. Study completion28 Feb 2021 (estimated)

Resources

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
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03304288
Sponsor's protocol ID
81670116
Status last verified
Jan 2021
First submitted
3 Oct 2017
Last updated
20 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu YJ, Liu H, Zeng QZ, Liu Y, Wang JW, Wang WS, Jia-Feng, Zhou HB, Huang QS, He Y, Fu HX, Zhu XL, Jiang Q, Jiang H, Chang YJ, Xu LP, Huang XJ, Zhang XH. All-trans retinoic acid plus low-dose rituximab vs low-dose rituximab in corticosteroid-resistant or relapsed ITP. Blood. 2022 Jan 20;139(3):333-342. doi: 10.1182/blood.2021013393.

    PubMed 34665865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and All-trans retinoic acid in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 4 sites in China.

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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

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?

overall response (time frame: From the start of study treatment (Day 1) up to the end of Year 1). 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 NCT03304288, which also lists 1 linked publication.

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 20 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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