Health TrialsbyHealthPanel

Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia

ConditionAplastic Anemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of chemoradiotherapy-induced aplastic anemia (AA)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old;

Diagnosed with relapsed/refractory chemoradiotherapy-induced AA. Relapsed/ refractory was defined as patients who had no response to at least 3 months of cyclosporine or thrombopoietin receptor agonists (TPO-RAs) such as eltrombopag;

At least one of the following conditions must be met: hemoglobin < 90 g/ L, platelet count < 30×109/L, neutrophil count < 1.0×109/L;

With baseline liver and kidney functions <2 upper limit of normal (ULN);

Disqualifiers

Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc.;

With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics;

Paroxysmal nocturnal hemoglobinuria (PNH) clone ≥ 50%;

Received hematopoietic stem cell transplantation before enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Romiplostim N01

    Drug

    Romiplostim N01 20 µg/kg subcutaneously once a week for at least 3 months

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Romiplostim N01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR (Overall Response Rate)

ORR=PRR (Partial Response Rate)+CRR (Complete Response Rate)

Time frame
3-month, 6-month

Secondary outcomes

1

CRR

Proportion of patients who achieved CR

Time frame
3-month, 6-month
2

Adverse event (AE) rate

Proportion of patients with AEs, according to CTCAE

Time frame
through study completion, an average of 1 year
3

Predictive factors for ORR or CRR

Calculated by single-/multivariate regression

Time frame
3-month
4

Clonal evolution rate

Proportion of patients progressed to myelodysplastic syndromes (MDS)/ acute myeloid leukemia (AML)

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: