Pentostatin

Overview

A potent inhibitor of adenosine deaminase. The drug is effective in the treatment of many lymphoproliferative malignancies, particularly hairy-cell leukemia. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.

Indication

For the treatment of hairy cell leukaemia refractory to alpha interferon.

Associated Conditions

Acute Graft-Versus-Host Disease (GVHD)
B-Lymphocytic, prolymphocytic leukemia (Kiel Classification) refractory
Chronic Lymphocytic Leukemia
Hairy Cell Leukemia (HCL)
Mycosis Fungoides (MF)
Sezary Syndrome
Steroid refractory Chronic graft versus host disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Patients With Refractory or Recurrent Severe Aplastic Anemia	2023/03/07	NCT05757310	Phase 1	Recruiting	City of Hope Medical Center
A Blood Stem Cell Transplant for Sickle Cell Disease	2017/08/15	NCT03249831	Phase 1	Active, not recruiting	City of Hope Medical Center
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)	2017/04/13	NCT03112603	Phase 3	Completed	Incyte Corporation
Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease	2017/03/13	NCT03077542	Phase 1	Active, not recruiting	National Heart, Lung, and Blood Institute (NHLBI)
Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure	2014/04/07	NCT02105766	Phase 2	Active, not recruiting	National Heart, Lung, and Blood Institute (NHLBI)
Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia	2012/09/10	NCT01681563	Phase 2	Completed	Niguarda Hospital
SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma	2011/05/30	NCT01362790	Phase 1	Completed	National Cancer Institute (NCI)
Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma	2011/05/11	NCT01352312	Phase 1	Terminated	Sidney Kimmel Cancer Center at Thomas Jefferson University
Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies	2010/08/25	NCT01188798	Phase 3	Completed	St. Jude Children's Research Hospital
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia	2010/02/01	NCT01059786	Phase 2	Active, not recruiting	National Cancer Institute (NCI)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nipent	Hospira, Inc.	0409-0801	INTRAVENOUS	2 mg in 1 mL	12/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Hospira Nipent (pentostatin for injection) 10 mg US	171027	Hospira Australia Pty Ltd	Medicine	A	5/4/2010
Hospira Nipent (Pentostatin for Injection) 10 mg	171028	Hospira Australia Pty Ltd	Medicine	A	5/4/2010

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NIPENT PWS 10MG/VIAL	parke-davis division, warner-lambert canada inc.	02011247	Powder For Solution - Intravenous	10 MG / VIAL	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NIPENT 10 mg POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Pfizer S.L.	59993	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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