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For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.

If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.

Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.

erythropoietin

If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.

iron supplementation

Wei Ping Liu

Xiao Pei Wang

This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.

Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.

Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation

Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation

proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant

proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant

proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant

Peking University

Chairman of Lymphoma Department

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Ferric gluconate

1. One (1) injection of Procrit®, by needle, inserted just under the skin;
2. 125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.

These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.

In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.

Epoetin Alfa plus Iron

Goetz H Kloecker, MD

The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.

There are more than 170,000 patients diagnosed with lung cancer in the United States each year and many will develop anemia (iron deficiency) during the course of treatment. Anemia is associated with poor quality of life and treatment delays for advanced lung cancer. The treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key element in red blood cells.

The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid (bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and it encourages red cell production. While the administration of intravenous iron therapy, injected into veins through an IV, did increase the response rate of Procrit® in a previous study, researchers want to find out the best amount of drug to use and the best time to administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.

Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia

A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks

James Graham Brown Cancer Center

University of Louisville

Associate Professor

Tin Fluorides

Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.

Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.

Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles with daily oral iron supplementation. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.

LY2787106

Iron Supplementation

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and without iron supplementation.

A Phase 1 Study of LY2787106 in Cancer and Anemia

A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia

Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.

Cmax is the maximum serum concentration after a single IV dose of the study drug.

AUC is the area under the concentration versus time curve from time zero to infinity.

MTD is defined as being the highest tested dose below the level at which one-third or more of participants experience a Dose-limiting toxicity (DLT). DLT is defined as an adverse event occurring in any part of the study that is related to the study medication, occurs during Cycle 1 of Part A, and fulfills any one of the following criteria:

1. Clinically significant Grade 2 toxicity, such as angina, arrhythmia, seizure, dyspnea, rash with significant blistering or desquamation, or other event deemed significant by either the investigator.
2. ≥Grade 3 anemia (excluding participants with baseline \<9.0 g/dL) or hemoglobin (Hb) decrease \>1.0 g/dL if baseline Hb \<9.0 g/dL, confirmed by 2 independent measurements.
3. ≥ Grade 3 cytokine release syndrome/acute infusion reaction.
4. Other ≥ Grade 3 hematological or non-hematological toxicity.

Mean change in serum iron from baseline to the end of Cycle 4.

Mean change in reticulocyte count from baseline to the end of Cycle 4.

Eli Lilly and Company

Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 0.3 mg/kg LY2787106

Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 1.0 mg/kg LY2787106

Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 3.0 mg/kg LY2787106

Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Part A 10.0 mg/kg LY2787106

Part B: Participants received 10.0 mg/kg of LY2787106, administered IV, on day 1 of up to eight 7-day cycles.

Part B 10.0 mg/kg LY2787106

Part B: 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Part B 10.0 mg/kg LY2787106+Iron

Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.

Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Chief Medical Officer

Participants with at least 1 TEAE event

Participants with at least 1 SAE event

Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.

Part B 10 mg/kg LY2787106

Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Part B 10 mg/kg LY2787106+Iron

All participants who received at least 1 dose of study drug.

Number of Participants With Clinically Significant Events

Evaluable population in Part B is defined as a participant who received all 4 of the first 4 per-cycle doses of study medication, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who had a hemoglobin assessment after each of the first 4 doses.

Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation

All participants who received at least 1 dose of study drug and who had evaluable PK data for Cmax.

Pharmacokinetics (PK): Maximum Concentration (Cmax)

All participants who received at least 1 dose of study drug and who had evaluable PK data for AUC\[0-∞\]).

PK: Area Under the Curve (AUC[0-∞])

MTD was not determined in this study, so zero participants were analyzed.

Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)

Evaluable Population in Part B is defined as a participant who has received all 4 of the first 4 per-cycle doses of study dose, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who has had a hemoglobin assessment after each of the first 4 doses.

Change From Baseline in Serum Iron

Mean Change From Baseline in Reticulocyte Count

Part A: Participants received 0.3 mg/kg, LY2787106 intravenously (IV), day 1 of up to three 21-day cycles.

Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106

Part B: Participants received 10.0 mg/kg LY2787106, IV, on day 1 of up to eight 7-day cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation	NCT03010579	Anemia Lymphoma Hematopoietic S...	erythropoietin iron supplement...	18 Years - 65 Years	Peking University
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia	NCT00481624	Anemia	Epoetin Alfa pl...	18 Years -	University of Louisville
A Phase 1 Study of LY2787106 in Cancer and Anemia	NCT01340976	Anemia	LY2787106 Iron Supplement...	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for iron supplementation