Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Leukemia, Myelomonocytic, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Leukemia, Myeloid

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Azacitidine

Epoetin Alfa

Antimetabolites

Enzyme Inhibitors

100 mg / m(2) subcutaneously day 1-5 every 4 weeks for 6 cycles. Another three cycles will be given together with epo for those not responding to the first 6 cycles of Azacitidine

For those patients not responding to Azacitidine alone, the combination of Azacitidine and erythropoetin 60 000 U / week for 16 weeks will be given.

Erythropoetin

Magnus Tobiasson, M.D.

Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with low-risk MDS. This study will evaluate the effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1) or low risk CMML. Included patients should first have failed, or considered not being eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to transfusion independency in this group of patients. Those patients who do not respond to treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO.

Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Clinical and Biological Evaluation of Azacitidine in Transfusion-dependent Patients With Low and Intermediate-1 Risk MDS, and Low-risk CMML, Who Are Either Refractory to or Not Eligible for Treatment With Erythropoietin +/- G-CSF

Nordic MDS Group

Immune System Diseases

Heart and Blood Diseases

Leukemia, Lymphoid

Anemia

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, B-Cell

Lymphosarcoma

Chronic Lymphocytic Leukemia

Micronutrients

Iron

Ferric Oxide, Saccharated

Neo-Recormon and Venofer

Michael Hedenus, MD

This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.

In this multi-center, randomized, open label phase-3 study, the correction of mild or moderate anemia and the effect on iron kinetics by rHuEPO treatment, with or without intravenous iron treatment, in patients with LPD not receiving antineoplastic therapy will be studied.

LENGTH OF STUDY 16 weeks

NUMBER OF CENTERS 15

NUMBER OF SUBJECTS 66

STRATIFICATION 1. According to diagnosis; CLL and indolent NHL vs. MM. 2. According to level of S-epo \> 100 IU/L vs £ 100 IU/L at baseline.

TREATMENT The patients will be randomized to receive 30 000 IU Neorecormon â (epoetin beta) s.c. once / week for 16 consecutive weeks +/- 100mg/week of Venofer â (iron sucrose) from week 0 to 6, followed by one 100mg dose every 2 week from weeks 8 until 14.

If the increase in Hb concentration is less than 10g/L from baseline (week 0) until week 4 weeks, the dose of epoetin beta will be increased to 60 000 IU weekly from week 5.

If the Hb concentration exceeds 140 g/L, the epoetin beta therapy will be suspended. The treatment will be resumed once the Hb concentration falls below 130 g/L. This resumed dose will be 75% of the previous dose (e.g. if the previous dose was 30 000 IU before suspension, the continued dose should be 22 500 IU. If the dose was 60 000 IU before suspension, the dose should be 45 000 IU).

If the level of S-ferritin reaches \>1000 ug/L iron sucrose should be suspended until the S-ferritin level falls below 500 ug/L.

Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.

Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders

Sundsvall Hospital

Hypertension

Myoma

Neoplasms, Connective and Soft Tissue

those with myoma with or without hypertension in holter monitoring

surgical removal of myoma by hysterectomy

myoma removal

javad kojuri, M.D.

The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.

Background:

Myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be a cause for secondary hypertension. Early reports suggested the association of myoma and hypertension. We studied the effect of myoma removal on hypertension and erythropoietin level to evaluate this hypothesis.

Patients \& Methods:

In this single centered prospective cohort study, in twenty eight patients who were candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum erythropoietin were checked before and 6 weeks after hysterectomy.

Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Shiraz University of Medical Sciences

javad Kojuri

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Vitamins

Docetaxel

Leucovorin

Fluorouracil

Cetuximab

Levoleucovorin

Cisplatin

Lenograstim

Folic Acid

Diphenhydramine

Promethazine

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Treatment with induction chemotherapy followed by radiation and cetuximab.

3D conformal radiation therapy or Intensity-Modulated Radiation Therapy (IMRT) with or without Image Guided Radiation Therapy (IGRT) will be used for all patients. Radiotherapy will be delivered in 1.8 to 2.25 Gy fractions daily, five days per week excluding holidays, for a total of 66-72 Gy delivered to the Gross Tumor Volume (GTV, defined below) plus appropriate margin and 44-59.4 Gy to at-risk lymph nodes as determined by primary tumor characteristics. Alternative fractionation and dosing schema may be used as deemed appropriate for an individual case. For IMRT, the minimum Planning Target Volume (PTV) dose should be 90% of the prescription dose and a minimum of 95% of the PTV should receive the prescribed dose.

Radiotherapy

5FU is given after, or at the midpoint, of the leucovorin infusion. Leucovorin is usually administered by I.V. bolus injection or short (10-120 minutes) I.V. infusion but oral formulation may be substituted should supply warrant.

Cetuximab will be given for the duration of radiotherapy. A loading dose of intravenous cetuximab at 400mg per square meter body-surface area will be given over two hours up to seven days prior to initiation of radiation treatments or on the day of the first treatment (drug information detailed below). Thereafter, cetuximab will be given weekly over 60 minutes at a dose of 250 mg per meter squared. Intravenous diphenhydramine (50 mg) will be given as premedication.

Neupogen®: 300 mcg/mL (1 mL, 1.6 mL). May be administered undiluted by SubQ injection. May also be administered by I.V. bolus over 15-30 minutes in D5W, or by continuous SubQ or I.V. infusion. Do not administer earlier than 24 hours after or in the 24 hours prior to cytotoxic chemotherapy.

Filgrastim

One cycle of induction chemotherapy will be comprised of docetaxel on day 1 and cisplatin and 5-fluorouracil given days 1, 8, and 15. Intravenous docetaxel will be administered over one hour at a dose of 75 mg per square meter of body-surface area, followed by intravenous cisplatin at 35 mg per square meter, administered during a period of 0.5 to 3 hours weekly. After completion of the cisplatin infusion, intravenous fluorouracil will be given as a bolus at 1000 mg per square meter, followed by leucovorin at the dose of 350mg/m2. There will be total 4 cycles of chemotherapy of which 2 cycles will be prior to radiation therapy and 2 cycles will be post-radiation.

Rene R Rubin, MD

More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes.

Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen.

Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.

Patients will be given two cycles of induction chemotherapy with Cisplatin, Docetaxel and Fluorouracil. This will be followed by six weeks of radiation therapy along with Cetuximab. Patients will get two more cycles of chemotherapy with the same agents after the completion of radiation therapy course. Patients will be watched very closely during the trial period, with close follow up of treatment responses and monitoring of any adverse effects.

Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer

Induction Chemotherapy With Taxotere, Cisplatin and 5-Fluorouracil Followed by Concomitant Cetuximab and Radiation for Locoregionally Advanced Squamous Cell Cancer of the Head and Neck: A Phase II Trial

to determine whether the intervention will prolong survival without needing salvage surgery (organ sparing survival)

we will determine if the intervention prolongs overall survival.

Drexel University College of Medicine

Intervention: early onset of Eprex60000 IU/week , at patient inclusion

Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).

EPREX

Sophie Park, Prof

Fatiha Chermat, CRA

Berengere gruson, MD

Berengere Gruson, MD

Sylvain THEPOT

Sylvain Tepot, MD

Bohrane Slama, MD

Anne Banos, MD

Elena-Catalina ENACHE, MD

Ana BERCEANU, MD

Thorsten Braun, MD

Christian Berthou, Prof

Stéphane Cheze, MD

Anne Violaine DONCKER, MD

Anaise BLOUET, MD

Benoit De RENZIS, MD

Célia Salanoubat, MD

Andrea TOMA, MD

Sophie Park, MD, PHD

Kamel Laribi, MD

Katell LE DU, MD

Christian Rose, MD

Christian Rose, Prof

Marie-Pierre Gourin, MD

Eric Wattel, MD, PHD

Norbert Vey, prof

REZA TABREZI, MD

Pierre Peterlin, MD

Thomas Cluzeau, MD

Pierre Fenaux, PHD

Pierre Fenaux, prof

Laurence Sanhes, MD

Sophie Dimicoli-Salazar, MD

Jose Miguel Torregrosa Diaz, MD

Pascale Cony-Makhoul, MD

Marius MOLDOVAN, MD

Chantal HIMBERLIN, MD

Stanislas Nimubona, MD

Aspasia Stamatoulas, MD

Aspasia Stamatoullas, MD

Elsa LESTANG, MD

Shanti NATAJARAN-AME, MD

Odile Beyne-Rauzy, Prof

Nadia ALI AMAR, MD

Jixing LIU, MD

Agnès Guerci-Bresler, MD

This is an open-label, randomized, multicenter, phase III study

Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks:

* Either at diagnosis Or
* at the Hb threshold chosen for RBC transfusions (must be \< 9g/dl)

in this trial we will compare the early introduction of EPO alfa to the delayed introduction in lower risk MDS with non RBC transfusion dependent anemia.

At enrollment patients will be randomised in the 2 arms (early and delayed start of EPO alfa).

Treatment Regimen Epoetin alfa 60000 UI/week for at least 12 weeks

1. Early onset arm: early onset of EPO ALFA 60000 IU/week , at patient inclusion
2. Delayed onset arm: late introduction of EPO ALFA 60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).

A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

A Randomized Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS With Non RBC Transfusion Dependent Anemia and Without Del 5q

RBC transfusion dependence will be defined by requirement of at least transfusions of 2 PRBC within an interval of less than 8 weeks, given for Hb \<8g/dl or \<9g/dl according to comorbidities and in the absence of other cause of anemia (bleeding, surgery...), taking into account only transfusions given at least 12 weeks after onset of treatment with EPO ALFA.

Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment

response duration to EPO ALFA measured from the date of enrollment until failure

Overall survival measured from the date of enrollment to death or the date of last contact

Groupe Francophone des Myelodysplasies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)	NCT01048034	Myelodysplastic... Chronic Myelomo...	Azacitidine Erythropoetin	18 Years -	Nordic MDS Group
Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.	NCT00145652	Anemia Multiple Myelom... Non Hodgkin Lym... Chronic Lymphoc...	Neo-Recormon an...	18 Months -	Sundsvall Hospital
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level	NCT00898170	Myoma Hypertension	myoma removal	22 Years - 55 Years	Shiraz University of Medical Sciences
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level	NCT00898170	Myoma Hypertension	myoma removal	22 Years - 55 Years	Shiraz University of Medical Sciences
Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer	NCT01467115	Head and Neck C...	Radiotherapy Leucovorin Cetuximab Filgrastim Erythropoetin Cisplatin Fluorouracil Docetaxel	18 Years -	Drexel University
A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS	NCT03223961	Myelodysplastic...	EPREX	18 Years -	Groupe Francophone des Myelodysplasies

Spots Global Cancer Trial Database for erythropoetin