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Clofarabine with Busulfan

Phase 2

Leukemia | Small molecule | Oncology |Sanofi|Last Updated: Apr 4, 2013

Target and mechanism

Molecular targetPOLA1, POLD4, POLD3, POLD1, POLD2, POLE
Target classInhibitor
ModalitySmall molecule

Also known as Clofarabine

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Clofarabine with Busulfan · 1 trial · 2 indications

Phase 2 1
NCT00852163Study of Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes Using Clofarabine and Busulfan RegimenLeukemia
COMPLETED20 Analytics
PHASE2COMPLETED
Study of Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes Using Clofarabine and Busulfan Regimen
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Study Endpoints

Primary Endpoints

Disease free survival at one and two year
At 1 year and 2 Year

Secondary Endpoints

Incidence of hematopoietic engraftment
100 days
Incidence and severity of acute toxicities
100 days
Pharmacokinetic profiles of high dose busulfan and standard dose clofarabine
Lesss than 8 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Clofarabine with BusulfanEXPERIMENTALClofarabine 40 mg/m2 IV QD × 5 days Busulfan (Busulfex™) 3.2 mg/kg IV QD × 2 days

Interventions

NameTypeDescription
Clofarabine with BusulfanDRUGClofarabine 40 mg/m2 IV QD × 5 days Busulfan (Busulfex™) 3.2 mg/kg IV QD × 2 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Disease Criteria: * Acute myelogenous leukemia (AML) * Acute lymphocytic leukemia (ALL) * Myelodysplastic syndromes (MDS) Refractory anemia (RA) with adverse cytogenetics (SWOG criteria) or beyond (RAEB, RAEB-T, AML) * Other Myeloproliferative Disorders Myelofibrosis, Agnogenic...

Countries:United States
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Competitive Landscape -Leukemia 327 trials

Top 20 of 63 competitors

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Blinatumomab, Low-intensity chemotherapy regimen
Eli Lilly and CompanyLLY9PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
BeOne Medicines Ltd. Sponsored ADRONC13PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab
AbbVie, Inc.ABBV24PHASE3Venetoclax
AstraZeneca PLCAZN18PHASE3Acalabrutinib, Rituximab, Chlorambucil
Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
Johnson & JohnsonJNJ12PHASE3Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Kura Oncology, Inc.KURA5PHASE3Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine
Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib
Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine
SELLAS Life Sciences Group, Inc.SLS1PHASE3Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Bristol-Myers Squibb CompanyBMY7PHASE2Azacitidine
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine- Cytarabine- Gilteritinib
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib
Actinium Pharmaceuticals, Inc. (Delaware)ATNM2PHASE3Iomab-B, Conventional Care
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Frequently asked questions about Clofarabine with Busulfan

What is CLOFARABINE used for?

CLOFARABINE is an investigational small molecule being studied for use in oncology, including B-Cell Lymphoma, Myelodysplastic Syndromes, Solid Tumors, Hematologic Malignancies, Acute Myeloid Leukemia, and Acute Lymphoblastic Leukemia, including in pediatric patients.

Who makes CLOFARABINE?

CLOFARABINE is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY.

What phase is CLOFARABINE in?

CLOFARABINE is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied in clinical trials for various oncological conditions.

What clinical trials is CLOFARABINE in?

CLOFARABINE has been studied in several clinical trials, including NCT00042354, a Phase 2 study in pediatric acute myelogenous leukemia; NCT00315705, a Phase 1 combination study in children with acute leukemias; NCT00477542, a Phase 1 trial in hematologic malignancies; and NCT01196013, a Phase 1 study in Japanese pediatric patients with acute lymphoblastic leukemia.

Is CLOFARABINE the same as other drugs?

CLOFARABINE is a distinct drug asset. It is not known to be the same as any other drug under a different name.

How does CLOFARABINE work?

CLOFARABINE is a small molecule. Its specific molecular target has not been disclosed in the available information.