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)
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.
Phase II study of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia. [2009.09.10]
PURPOSE: To determine the efficacy and safety of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia (AML)... CONCLUSION: Clofarabine is active in pediatric patients with multiply relapsed or refractory AML. Responses allowed several refractory patients to proceed to HSCT. The toxicity profile was expected in this patient population.
Allo-SCT conditioning for myelodysplastic syndrome and acute myeloid leukemia with clofarabine, cytarabine and ATG. [2009.07]
The application of myeloablative Allo-SCT is limited by its associated morbidity and mortality. Reduced-intensity conditioning regimens attempt to diminish these, but are associated with a higher risk of disease relapse.This regimen was not sufficiently immunosuppressive to ensure engraftment, and was associated with substantial morbidity and mortality.
Enhancement of the in vivo antitumor activity of clofarabine by 1-beta-D-[4-thio-arabinofuranosyl]-cytosine. [2009.07]
PURPOSE: Clofarabine increases the activation of 1-beta-D-arabinofuranosyl cytosine (araC) in tumor cells, and combination of these two drugs has been shown to result in good clinical activity against various hematologic malignancies. 1-beta-D-[4-thio-arabinofuranosyl] cytosine (T-araC) is a new cytosine analog that has exhibited excellent activity against a broad spectrum of human solid tumors and leukemia/lymphoma xenografts in mice and is currently being evaluated in patients as a new drug for the treatment of cancer. Since T-araC has a vastly superior preclinical efficacy profile in comparison to araC, we have initiated studies to determine the potential value of clofarabine/T-araC combination therapy... CONCLUSIONS: These studies provide a rationale for clinical trials using this combination in the treatment of acute leukemias as well as solid tumors and suggest that this combination would exhibit greater antitumor activity than that of clofarabine plus araC.
Clofarabine as a novel nucleoside analogue approved to treat patients with haematological malignancies: mechanism of action and clinical activity. [2009.06]
Clofarabine is a second generation of purine nucleoside analogues designed to combine the most favorable pharmacokinetic properties of fludarabine and cladribine. Clofarabine acts by inhibiting DNA polymerases and ribonucleotide reductase as well as by inducing apoptosis in cycling and non-cycling cells...
Clinical Trials Related to Clolar (Clofarabine)
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With AML and High-Risk MDS. [Completed]
Clofarabine is a chemotherapy drug that is designed to interfere with the growth and
development of cancer cells. Ara-C is a chemotherapy drug which is approved for the treatment
of AML and MDS. Although there is experience with the combination of both drugs, there have
not been any phase 1 trials that explored the particular doses and schedule of clofarabine
plus ara-C that a patient may receive.
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II) [Active, not recruiting]
Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the
treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia
(ALL) who have had at least 2 prior treatment regimens.
This study will evaluate the efficacy of clofarabine in elderly patients with AML who may not
benefit from or tolerate treatment with other chemotherapy drugs used in younger patients
with AML (cytarabine and anthracyclines)
Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors [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 acute lymphoblastic leukemia
(ALL) who have had at least 2 prior treatment regimens.
This is a research study of clofarabine that will be given to patients (orally) with advanced
cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer
effective or no reliable effective treatment is available.
The purpose of this study is to find the answers to the following research questions:
1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days
followed by 23 days of rest and repeated every 28 days?
2. What are the side effects of clofarabine when given on this schedule?
3. How much oral clofarabine is in the blood at specific times after administration and how
does the body get rid of the drug?
4. Will oral clofarabine help treat solid tumor cancer?
Clofarabine and AraC for the Treatment of AML, MDS [Active, not recruiting]
Clofarabine in Adult Patients With Advanced Solid Tumors [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 acute lymphoblastic leukemia
(ALL) who have had at least 2 prior treatment regimens.
This research study of clofarabine will be used for advanced cancer in persons in which drugs
are no longer effective or no reliable effective treatment is available. The purpose of this
study is to find the answers to the following research questions:
1. What is the largest dose of clofarabine that can be safely administered as an IV
infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by
1 week of rest and repeated every 28 days?
2. What are the side effects of clofarabine when given on this schedule?
3. How much clofarabine is in the blood at specific times after administration and how does
the body get rid of the drug? Once the MTD/RP2D is established, patients will be
enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every
other cycle.
4. Will clofarabine help treat a specific cancer?
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