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AND017

Yusha Zhu, MD, PhD

This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).

A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome

An Efficacy and Safety Study of AND017 for the Treatment of Anemia Due to Lower Risk Myelodysplastic Syndromes (MDS)

* NTD cohort: non-transfused Hb levels ≥1.5 g/dL relative to baseline\* during any 8-week period from baseline to 24 weeks post-dose.
* LTB-1 cohort: No transfusion during any 8-week period from baseline to 24 weeks post-dose.
* LTB-2 cohort: No transfusions during any 8-week period from baseline to 24 weeks post-dose and untransfused Hb levels ≥1.5 g/dL.

  * Hb baseline is the average of the two lowest Hb over the 16 weeks prior to the first dose

Mean level and change from baseline in untransfused Hb throughout the first 8 weeks of treatment

Mean level and change from baseline in untransfused Hb at each visit throughout the treatment period and

Percentage of visits in which untransfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period

Mean time required after two consecutive increases in untransfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period

For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose)

For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period

Levels of reticulocyte count at each visit and change from baseline

Levels of hematocrit at each visit and change from baseline

Levels of mean corpuscular volume at each visit and change from baseline

Levels of mean corpuscular hemoglobin at each visit and change from baseline

Kind Pharmaceuticals LLC

Oral administration of AND017 capsules three times per week

The purpose of this study is to determine the safety and efficacy of AND017 after 6 weeks of treatment in patients with cancer-related anemia who are receiving chemotherapy.

A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy

A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Cancer-Related Anemia Patients Receiving Chemotherapy

Responding patient is defined as those with a maximum change from baseline in hemoglobin level greater than 10% during the treatment

The percentage of subjects who need to receive blood transfusion during the treatment

Mean and change from baseline in hemoglobin levels at each study visit

The maximum change from baseline in hemoglobin during the treatment

Percentage of visits in which subjects maintained a hemoglobin between elevation \>10% of baseline and hemoglobin\<12.0 g/dL after reaching an elevation of 10% from baseline

Percentage of subjects whose hemoglobin remained between elevation \>10% of baseline and hemoglobin\< 12.0 g/dL after 5 weeks treatment

Time for hemoglobin reaching an elevation of \>10% from baseline during treatment

The purpose of this study is to determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy

A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Anemia of Cancer in Patients Not Receiving Chemotherapy

Responding patient is defined as those with a maximum elevated hemoglobin level greater than 10% of baseline from baseline to five weeks after dosing.

The percentage of subjects who need to receive blood transfusion during the trial

Maximum change in hemoglobin from baseline to 5 weeks post-dose

Percentage of visits in which subjects maintained a hemoglobin elevation between \>10% and 12.0 g/dL above baseline after reaching 10% of baseline

Percentage of patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment

Percentage of subjects requiring blood transfusions during the trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome	NCT06304103	Myelodysplastic...	AND017	18 Years - 75 Years	Kind Pharmaceuticals LLC
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy	NCT06075030	Chemotherapy In...	AND017	18 Years -	Kind Pharmaceuticals LLC
A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy	NCT06075043	Cancer-Related ...	AND017	18 Years -	Kind Pharmaceuticals LLC
A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome	NCT06304103	Myelodysplastic...	AND017	18 Years - 75 Years	Kind Pharmaceuticals LLC

Spots Global Cancer Trial Database for and017

Every month we try and update this database with for and017 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for and017

Every month we try and update this database with for and017 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for and017 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.