Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Myeloproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Clofarabine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Induction:

Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)

Consolidation:

Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)

Induction:

10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)

Consolidation:

10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)

Induction:

20 mg subcutaneously twice daily for 7 days (days 1-7)

Consolidation:

20 mg subcutaneously twice daily for 5 days (days 1-5)

Guillermo Garcia-Manero, MD

The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied.

Clofarabine is designed to interfere with the growth and development of cancer cells.

Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.

Induction Cycles:

If you are found to be eligible to take part in the study, on Days 1-5 of each cycle , you will receive clofarabine by vein over 1-2 hours.

On Days 1-7 of each cycle, you will receive cytarabine by injection under the skin over several seconds 2 times a day.

You may receive up to 3 cycles at this dose and schedule (also called "induction cycles"). There are 7 treatment days in each cycle but the total length of one cycle (including rest and recovery period) is usually between 4 and 8 weeks.

Consolidation Cycles:

After you have completed the Induction Cycles, if you show a response to treatment, you can then continue with up to a total of 12 more cycles of therapy, which will be called "consolidation cycles". Not every participant may be able to receive all 12 consolidation cycles. The actual number that you will receive depends on whether or not you maintain the response and how you are able to tolerate ongoing therapy. There will be 4-8 weeks between each consolidation cycle depending on any side effects you may be having and your blood counts.

During consolidation cycles you will receive clofarabine on Days 1-3 by vein over 1-2 hours. You will receive cytarabine by injection under the skin over several seconds 2 times a day .

Induction and Consolidation Cycles:

On the days when you receive clofarabine and cytarabine (Days 1-5 during induction and Days 1-3 during consolidation), the clofarabine will be given about 3-6 hours before the cytarabine injections. You can be taught to give cytarabine injections to yourself. In this case, you can leave the clinic after receiving clofarabine. You will be required to record the injections of cytarabine in a diary unless you receive the treatments while you are in the hospital.

Study Visits:

On Day 1 of every cycle (+/- 7 days):

* You will have a physical exam, including measurements of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.

About 4 weeks after you started your first cycle, you may have a bone marrow aspirate to check the status of the disease. After that, you may have repeat bone marrow aspirates when the doctor thinks it is needed.

It is recommended that you stay in Houston for up to the first 4 weeks of treatment. After that, you will need to return to Houston before each induction cycle. If you continue with the consolidation you can receive these treatments by your local oncologist. However, you have to return to Houston at least every 3 months for your study visits.

Length of Study:

You may continue taking the study drugs for up to 15 cycles. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Clofarabine is FDA approved and commercially available for use in pediatric patients with acute lymphoblastic leukemia. Its use in adults and in patients with MDS is investigational.

Cytarabine is FDA approved and commercially available for use in patients with acute myeloid leukemia (AML).

Up to 80 patients will take part in this study. All be enrolled at MD Anderson.

Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)

Clofarabine Plus Low-Dose Cytarabine for the Treatment of Patients With Higher-Risk Myelodysplastic Syndrome (MDS) Who Have Been Relapsing After, or Are Refractory to, Hypomethylator Therapy

Complete Response Criteria (CR must last for at least 4 weeks): Marrow: \</= 5% myeloblasts with normal maturation of all cell lines; Persistent dysplasia noted; Blood: Hemoglobin (Hb) \>/= 11 g/dL (untransfused, patient not on EPO); Neutrophils \>/= 1x109/L (not on myeloid growth factor); Platelets \>/= 100 \* 109/L (not on thrombopoietic agent); No blasts. Bone marrow aspirate and/or biopsy at the end of course 1 (day 28 +/- 7 days). The method of Thall, Simon, and Estey used to monitor response.

Overall survival defined as the time interval from study entry date to the date of death due to any cause, measured in days/months. Bayesian time-to-event model used to monitor overall survival.

M.D. Anderson Cancer Center

Induction:

Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)

Consolidation:

Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)

Clofarabine: Induction:

10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)

Consolidation:

10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)

Cytarabine: Induction:

20 mg subcutaneously twice daily for 7 days (days 1-7)

Consolidation:

20 mg subcutaneously twice daily for 5 days (days 1-5)

Clofarabine + Cytarabine

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Guillermo Garcia-Manero, MD/Professor

One of the eighty-one participants registered on the study were in evaluable for response.

Number of Participants With Complete Response (CR)

Overall Survival (OS)

Overall Study

Heart and Blood Diseases

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Thalidomide

Dexamethasone

Melphalan

Bortezomib

Dexamethasone acetate

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles

Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity

Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day

Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity

Martin Hjorth, MD, PhD

The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.

The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.

The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.

The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.

Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.

Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

Nordic Myeloma Study Group

Martin Hjorth

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)	NCT01444742	Leukemia Myeloproliferat...	Clofarabine Cytarabine	18 Years -	M.D. Anderson Cancer Center
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma	NCT00602511	Multiple Myelom...	Bortezomib Thalidomide	18 Years -	Nordic Myeloma Study Group

Spots Global Cancer Trial Database for relapsing

Every month we try and update this database with for relapsing 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 relapsing

Every month we try and update this database with for relapsing 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 relapsing 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.