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clofarabine

Generic: CLOFARABINE·Brand: CLOFARABINE, CLOLAR, Clolar

clofarabine: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.

clofarabine evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect clofarabine to RDY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could clofarabine → RDY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 1 study sponsors
Development Pipeline (1)
CompanyPhase
DR REDDYS LABORATORIES LTD (RDY)Approved
Clinical Trials (4)

A Phase lb Study of Vyxeos® (Liposomal Daunorubicin and Cytarabine) in Combination With Clofarabine in Children With Relapsed/Refractory AML, ITCC-092

NCT07156435·Phase 1·JAZZ
Recruiting

Primary endpoint: Dose finding for combination Vyxeos® with clofarabine

Interventionalopen25 targetStarted 2020-11Completion 2028-1213 sites · Austria, Denmark, Germany, Italy…Princess Maxima Center for Pediatric Oncology

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

NCT03117751·Phase 2/Phase 3
Active, not recruiting

Primary endpoint: Event-free survival of ALL patients (EFS)

InterventionalRandomizedsingle790 targetStarted 2017-03Completion 2028-098 sites · Australia, United StatesSt. Jude Children's Research Hospital

Phase II Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders

NCT02425904·Phase 2
Active, not recruiting

Primary endpoint: Response Rate (OR) of LCH Cohort

Interventionalopen25 targetStarted 2015-05Completion 2026-1215 sites · Canada, United StatesDana-Farber Cancer Institute

Phase II Study of Clofarabine and High-Dose Melphalan Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation for Myelodysplasia or Acute Leukemia in Remission

NCT01885689·Phase 2
Active, not recruiting

Primary endpoint: Progression-free Survival at 2 Years

Interventionalopen72 enrolledStarted 2014-02Completion 2026-091 site · United StatesCity of Hope Medical Center
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Clofarabine injection 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. Clofarabine injection is a nucleoside metabolic inhibitor 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. ( 1 )(RDY)FDA ↗
ANDA205375UNKNOWNStandardIntravenousSolution

Frequently asked questions

Who is developing clofarabine?

clofarabine is being developed by DR REDDYS LABORATORIES LTD.

How many clinical trials involve clofarabine?

BioSniper tracks 4 clinical trials involving clofarabine.

What is clofarabine's latest FDA decision?

The most recent tracked FDA decision for clofarabine is Approval for 1 INDICATIONS AND USAGE Clofarabine injection 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. Clofarabine injection is a nucleoside metabolic inhibitor 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. ( 1 ), dated November 6, 2017.