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Clolar (Clofarabine) - Summary

 
 



CLOLAR SUMMARY

Clolar® (clofarabine) injection contains clofarabine, a purine nucleoside anti-metabolite. Clolar® (1 mg/mL) is supplied in a 20 mL, single-use vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and free from foreign matter.

Clolar® is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.


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NEWS HIGHLIGHTS

Published Studies Related to Clolar (Clofarabine)

Clofarabine +/- fludarabine with once daily i.v. busulfan as pretransplant conditioning therapy for advanced myeloid leukemia and MDS. [2011.06]
Although a combination of i.v...

A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. [2008.09.01]
We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients... This trial is registered at www.clinicaltrials.gov as no.

Clofarabine doubles the response rate in older patients with acute myeloid leukemia but does not improve survival. [2013]
Better treatment is required for older patients with acute myeloid leukemia (AML) not considered fit for intensive chemotherapy. We report a randomized comparison of low-dose Ara-C (LDAC) vs the novel nucleoside, clofarabine, in untreated older patients with AML and high-risk myelodysplastic syndrome (MDS).

Phase I pharmacokinetic and pharmacodynamic study of the multikinase inhibitor sorafenib in combination with clofarabine and cytarabine in pediatric relapsed/refractory leukemia. [2011.08.20]
PURPOSE: To assess the toxicity, pharmacokinetics, and pharmacodynamics of multikinase inhibitor sorafenib in combination with clofarabine and cytarabine in children with relapsed/refractory leukemia... CONCLUSION: Sorafenib in combination with clofarabine and cytarabine is tolerable and shows activity in relapsed/refractory pediatric AML.

Early UK experience in the use of clofarabine in the treatment of relapsed and refractory paediatric acute lymphoblastic leukaemia. [2011.08]
Clofarabine is a second-generation purine nucleoside analogue, which has shown promising activity in relapsed and refractory paediatric acute lymphoblastic leukaemia (ALL)... Responses were seen in both B and T cell disease and in patients with adverse cytogenetics.

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Clinical Trials Related to Clolar (Clofarabine)

Clofarabine Combinations in Relapsed/Refractory AML, MDS and Myeloid Blast Phase CML [Completed]
The goal of this clinical research study is to find the best safe dose for 2 different drug combinations. For this purpose, participants will either receive the combination of clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose for these drug combinations are found, the next goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy. In the current extension part of the study, you will only receive the clofarabine/idarubicin/ara-C combination. The activity and the safety of this treatment will be studied.

Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL [Active, not recruiting]
Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL) and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation (AlloSCT).

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome [Recruiting]
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control AML and MDS. The safety of these study drug combinations will also be studied.

Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of gemcitabine (out of 6 possible doses) that can be given in combination with busulfan and clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if this combination can help to control lymphoma. The safety of this treatment will also be studied. Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die. It is commonly used in stem cell transplants. Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may cause the cancer cells to die.

A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias. [Completed]
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.

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Reports of Suspected Clolar (Clofarabine) Side Effects

Pyrexia (16)Acute Lymphocytic Leukaemia (16)Sepsis (15)Febrile Neutropenia (14)Neutropenia (12)Pleural Effusion (9)Renal Failure Acute (9)Death (8)Acute Myeloid Leukaemia (8)Renal Failure (8)more >>


Page last updated: 2014-11-30

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