Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Lenalidomide

Epoetin Alfa

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Participants in the Pharmacokinetic Phase received a single 10 mg oral dose of lenalidomide on Day -7. During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

Following the enrollment of the first 25 patients into the Monotherapy Phase, a second group of 15 patients with low- or intermediate-1-risk MDS not associated with a del 5q (non-del 5q) cytogenetic abnormality were enrolled to receive 15 mg of lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

Lenalidomide 5-mg capsules for oral administration

Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units.

Recombinant human erythropoietin

Robert Knight, MD

The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).

A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes

Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method.

Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method.

The maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after a single dose on day -7.

The Maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days.

The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).

Percent of the administered dose of lenalidomide excreted unchanged in urine over 24 hours postdose after a single dose on Day -7, calculated as:

(amount excreted unchanged in urine over 24 hours postdose / Dose) \* 100.

The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers.

Percent of the administered lenalidomide dose excreted unchanged in urine over 5 hours postdose after multiple dosing for 14 days, calculated as:

(amount excreted unchanged in urine over the first 5 hours postdose / Dose) \* 100.

The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers.

Time to the first event of grade 4 neutropenia or thrombocytopenia, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, was calculated as date of first event - date of first dose + 1.

Erythroid response was categorized as either a major response or a minor response. A major response was defined as red blood cell (RBC) transfusion independence during any consecutive 56-day period and an increase in hemoglobin of at least 1.5 g/dL. A minor response was defined as a ≥ 50% or ≥ 4 unit decrease in RBC transfusions from pretreatment requirements (the number of RBC transfusions required over an 8-week period before the start of study drug treatment).

To evaluate the predictive value of pretreatment serum erythropoietin (EPO) concentration for erythroid response to lenalidomide, the percentage of erythroid responders versus non-responders were stratified by Baseline EPO levels (≤ 500 mIU/mL versus \> 500 mIU/mL). Response includes participants with either a major or minor response.

Bone marrow cellularity is the volume ratio of hematopoietic stem cells and adipocytes (fat cells). Due to the small number of bone marrow samples, this analysis was not performed.

Due to the low number of bone marrow samples collected this analysis was not performed.

Celgene Corporation

Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.

During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

10 mg Lenalidomide

Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

15 mg Lenalidomide

Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.

During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

10 mg Non-del 5q

Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

15 mg Non-del 5q

Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.

During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

10 mg Del 5q

Total

Age Continuous

Sex: Female, Male

White

Hispanic

Other

Participants could select more than 1 race option.

Race/Ethnicity, Customized

Duration of MDS

Low risk (0)

Intermediate-1 (0.5-1.0)

The MDS IPSS score = sum of marrow blast + karyotype + cytopenia score. Score ranges from 0 (low risk) to 3.5 (high risk).

International Prognostic Scoring System (IPSS) Score

ECOG performance status: 0 = Fully active, no restrictions; 1 = Restricted but ambulatory and capable of light work; 2 = Ambulatory and capable of self-care but unable to work.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Refractory anemia (RA)

Refractory anemia with ringed sideroblasts (RARS)

Refractory anemia with excess blasts (RAEB)

Refractory anemia with excess blasts -1 (RAEB-1)

Refractory anemia: characterized by less than 5% primitive blood cells (myeloblasts) in the bone marrow and pathological abnormalities primarily seen in red cell precursors; RARS: distinguished by the presence of 15% or greater red cell precursors in the marrow being abnormal iron-stuffed cells called "ringed sideroblasts"; RAEB: characterized by 5-20% myeloblasts in the marrow; RAEB-1: characterized by 5% to 9% blasts in the bone marrow and less than 5% blasts in the blood.

French-American-British (FAB) classification of MDS

< 500 mIU/mL

≥ 500 mIU/mL

Missing

Serum erythropoietin level

Associate Director, Clinical Trials Disclosure

Participants received a single oral dose of 10 mg lenalidomide on Day -7.

PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide

Total Lenalidomide

S-Lenalidomide

R-Lenalidomide

PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)

During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.

Monotherapy Phase pharmacokinetic population.

Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)

PK Phase: Terminal Half-life (t1/2)

PK Phase participants for whom data was available.

PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose

Monotherapy Phase Pharmacokinetic Population.

Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose

Grade 4 Neutropenia

Grade 4 Thrombocytopenia

Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

Non-del 5q

Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

Del 5q

Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.

Time to Grade 4 Neutropenia or Thrombocytopenia

Major response

Minor response

Percentage of Participants With a Erythroid Response Across All Phases

Baseline EPO ≤ 500 mIU/mL

Baseline EPO > 500 mIU/mL

Responders

Participants who were not erythroid responders.

Non-responders

All participants in the Safety population.

Overall

Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level

Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.

Unable to obtain sufficient bone marrow samples to perform analyses.

Change From Baseline in Bone Marrow Cellularity and Correlation With Grade 4 Myelosuppression

Monotherapy Phase pharmacokinetic population

Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide

Unable to obtain sufficient bone marrow samples to perform analyses

Marrow-infiltrating Lymphocyte (MIL) Number and Cytolytic Activity

Pharmacokinetic Phase

Monotherapy Phase

Combined Treatment Phase

Anemia

recombinant human erythropoietin

recombinant human erythropoietin placebo

Yoshiharu Ishikura

To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy

A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Chugai Pharmaceutical

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

To determine the efficacy and safety of recombinant human erythropoietin in improving anemia in patients with lymphoma, and to improve the quality of life and the efficacy of chemotherapy in patients with lymphoma.

wenbin qian

xibin xiao

The incidence of lymphoma and anemia is high and the clinical harm is great.However, it has not yet attracted enough clinical attention, and domestic rHuEPO (trade name: Ebio).Shenyang Sansheng Pharmaceutical Co., Ltd.) for lymphoma and anemia patients are less clinical studies.Therefore, a prospective, open-label, multicenter clinical study of recombinant human erythropoietin in the treatment of anemia in patients with lymphoma is planned to analyze the efficacy and safety of recombinant human erythropoietin in patients with lymphoma and anemia, so as to determine the clinical benefits of recombinant human erythropoietin in patients with lymphoma and anemia.

Anemia is a common complication of malignant lymphoma.Approximately 30-40% of lymphoma patients develop anemia before chemotherapy begins \[1\].Common clinical manifestations of anemia include fatigue, weakness, dizziness, headache, shortness of breath, depression and other symptoms.Lymphoma anemia has a complex etiology, including chronic anemia (ACD), autoimmune hemolytic anemia (AIHA), bone marrow infiltration, malnutrition, and blood loss \[2\].

The incidence and prevalence of anemia are positively correlated with the severity of the disease and the chemotherapy cycle.A multi-center survey of anemia in patients with lymphoma in Shanghai published in 2020 included 501 patients, and the results showed that the incidence of anemia in patients with lymphoma was 35.5%;The prevalence of anemia was 62.7 percent during the entire 6-month follow-up period.Among the newly treated patients, the incidence of anemia was significantly higher in patients with Ann Arbor staging from Ⅲ to normal (P \< 0.001), indicating that the incidence of anemia was related to the severity of the disease.In addition, chemotherapy is also a key factor in the development of anemia during the course of the disease.In this Shanghai survey, 267 newly treated lymphoma patients receiving chemotherapy increased the rate of newly diagnosed anaemia from 6.82% in the first course of chemotherapy to 43.18% in the fourth course of chemotherapy and above \[3\].The results of the European Anemia Survey of 15,367 cancer patients (ECAS) conducted in 2004 also showed a high incidence of anemia in lymphoma patients (2 260 lymphoma patients, 52.5%) \[4\], and the cumulative incidence of anemia in patients increased with the increase of chemotherapy cycles \[5\].

Anemia can reduce the quality of life of tumor patients, affect the therapeutic effect, and shorten the survival period of patients \[6\].A number of studies have shown that anemia is an independent risk factor affecting the prognosis of patients with diffuse large B-cell lymphoma (DLBCL) \[7, 8\].Compared with patients with Hb≥10 g/dL, those with Hb≥10 g/dL were more likely to have bone marrow involvement before treatment.Patients with lymphoma at 10 g/dL showed a lower event-free and disease-free survival.R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) was also an independent predictor of disease recurrence and an independent predictor of International Prognostic Index (IPI) 6 months after chemotherapy \[7\].After 3-4 courses of chemotherapy, the efficacy of newly treated lymphoma patients was evaluated, and it was found that the efficacy gradually deteriorated with the increase of anemia level \[3\].Another domestic study found that among 12L patients treated with R-CHOP regimen, 77 patients had grade 2 anemia or above (Hb \< 10g/ dL, 63.6%), and the analysis results of the relationship between different Hb grades and overall survival showed that the greater the degree of anemia, the lower the overall survival rate of patients \[9\].

Although patients with lymphoma have a higher incidence of anemia, most patients do not receive prompt treatment.ECAS survey showed that anemia treatment rate of lymphoma patients was low, only 47.4%\[4\].For patients with tumor-associated anemia, treatment includes red blood cell transfusions, erythropoiesis stimulants (ESAs), and iron.Before the emergence of ESAs, blood transfusion was the main treatment.Although blood transfusions can quickly raise Hb levels, there are risks associated with allergies, viral infection, immunosuppression and iron overload.So the only Hb\&lt;Blood transfusion should be considered at 60 g/L or when hypoxia is urgently corrected clinically.ECAS survey showed that recombinant human erythropoietin (rHuEPO) was the main treatment for cancer anemia, but the treatment rate was low (17.4%) \[4\].Previous studies have confirmed that rHuEPO has achieved positive efficacy in the treatment of anemia caused by solid tumors and hematologic tumors.A 2008 study showed that the response rate of 33 NHL patients receiving chemotherapy treated with rHuEPO was 84.8%, and the earlier the treatment of rHuEPO, the higher the response rate \[10\].Glossmann J P et al. investigated the effects of rHuEPO on Hb level, blood transfusion volume and quality of life in patients with recurrent lymphoma, and found that while rHuEPO increased Hb level, it reduced the need for blood transfusion and improved the quality of life of patients \[11\].However, in recent years, concerns about the safety of rHuEPO in cancer patients have limited its clinical application.In recent years, large meta-analyses and randomized controlled studies have not shown that ESAs promote tumor progression \[12-15\].The "Management of Anemia and Iron Deficiency in Cancer Patients: ESMO Clinical Practice Guidelines" published by the European Society of Physicians of Oncology (ESMO) in 2018 also clearly pointed out that the standardized use of ESAS would not promote the progression or recurrence of cancer disease \[16\].Therefore, the appropriate use of rHuEPO in lymphoma patients undergoing chemotherapy can provide clinical benefits such as reduced need for blood transfusion and improved quality of life without excessive safety concerns.

In view of the high incidence of lymphoma anemia and greater clinical harm.However, it has not yet attracted enough clinical attention, and domestic rHuEPO (trade name: Ebio).Shenyang Sansheng Pharmaceutical Co., Ltd.) for lymphoma and anemia patients are less clinical studies.Therefore, a prospective, open-label, multicenter clinical study of recombinant human erythropoietin in the treatment of anemia in patients with lymphoma is planned to analyze the efficacy and safety of recombinant human erythropoietin in patients with lymphoma and anemia, so as to determine the clinical benefits of recombinant human erythropoietin in patients with lymphoma and anemia.

Clinical Study the Efficacy and Safety of Rh-EPO in the Treatment of Anemia in Lymphoma

Prospective, Open-label, Multicenter Clinical Study for the Efficacy and Safety of Recombinant Human Erythropoietin in the Treatment of Anemia in Patients With Lymphoma

A hemoglobin response was defined as an increase in hemoglobin levels of ≥ 1.0 g/dL from baseline during 2 or more consecutive assessments (2 weeks apart) without red blood cell infusion.

The time of the first hemoglobin response

First People's Hospital of Hangzhou

Zhejiang Provincial Tongde Hospital

The First Affiliated Hospital of Zhejiang Chinese Medical University

Zhejiang Cancer Hospital

Wenzhou Central Hospital

First Affiliated Hospital of Wenzhou Medical University

Ningbo Medical Center Lihuili Hospital

Affiliated Hospital of Jiaxing University

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Second Affiliated Hospital of Wenzhou Medical University

Second Affiliated Hospital, School of Medicine, Zhejiang University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Darbepoetin alfa

Darbepoetin Alfa

Recombinant Human Erythropoietin

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Treatment for Patients Suffering From Anemia Due to Chemotherapy

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Amgen

Global Development Leader

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Epoetin alfa and Darbepoetin alfa

Ortho Biotech Products, L.P. Clinical Trial

The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.

Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously (\[SC\], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety \& efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa.

Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes	NCT00910858	Low- or Interme...	Lenalidomide Recombinant hum...	18 Years -	Celgene
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy	NCT00144482	Chemotherapy In...	recombinant hum... recombinant hum...	20 Years - 79 Years	Chugai Pharmaceutical
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes	NCT00910858	Low- or Interme...	Lenalidomide Recombinant hum...	18 Years -	Celgene
Clinical Study the Efficacy and Safety of Rh-EPO in the Treatment of Anemia in Lymphoma	NCT04910594	Lymphoma Anemia	recombinant hum...	14 Years - 65 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Treatment for Patients Suffering From Anemia Due to Chemotherapy	NCT00120692	Breast Cancer Anemia	Darbepoetin Alf... Recombinant Hum...	18 Years -	Amgen
Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia	NCT00315484	Anemia Chemotherapy	Epoetin alfa an...	18 Years -	Ortho Biotech Products, L.P.
Treatment for Patients Suffering From Anemia Due to Chemotherapy	NCT00120692	Breast Cancer Anemia	Darbepoetin Alf... Recombinant Hum...	18 Years -	Amgen

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