NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified (see DOSAGE AND ADMINISTRATION) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m2 in divided doses over 5 days) than recommended.
In a clinical investigation in patients with refractory chronic lymphocytic leukemia using NIPENT at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of NIPENT in combination with fludarabine phosphate is not recommended.
Nipent® (pentostatin for injection)
NIPENT® (pentostatin for injection) is supplied as a sterile, apyrogenic, lyophilized powder in single-dose vials for intravenous administration. Each vial contains 10 mg of pentostain and 50 mg of Mannitol, USP. The pH of the final product is maintained between 7.0 and 8.5 by addition of sodium hydroxide or hydrochloric acid.
NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Published Studies Related to Nipent (Pentostatin)
Prophylaxis of graft-versus-host disease in unrelated donor transplantation with pentostatin, tacrolimus, and mini-methotrexate: a phase I/II controlled, adaptively randomized study. [2011.01.20]
PURPOSE: Acute graft-versus-host disease (aGVHD) is a major cause of morbidity and mortality after matched unrelated, related, or mismatched related donor hematopoietic stem-cell transplantation (HSCT). Improved GVHD prevention methods are needed. Pentostatin, an adenosine deaminase inhibitor, leads to lymphocyte depletion with low risk of myelosuppression. We hypothesized that addition of pentostatin to GVHD prophylaxis with tacrolimus and mini-methotrexate may improve outcomes, and we conducted a Bayesian adaptively randomized, controlled, dose-finding study, taking into account toxicity and efficacy... CONCLUSION: Pentostatin increased the likelihood of success as defined here, and should be further investigated in larger randomized, confirmatory studies.
Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network. [2009.07.16]
Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation...
Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin. [2000.11.01]
The nucleoside analogue, pentostatin, has demonstrated high complete response rates and long relapse-free survival times in patients with hairy cell leukemia, a disease that historically had been unresponsive to treatment. Long-term data on duration of overall survival and relapse-free survival and incidence of subsequent malignancies with this agent are lacking...
Randomized comparison of pentostatin versus interferon alfa-2a in previously untreated patients with hairy cell leukemia: an intergroup study. [1995.04]
PURPOSE: Therapy of hairy cell leukemia has markedly improved. Interferon alfa-2a and pentostatin are active agents. The National Cancer Institute organized an intergroup trial to compare these agents prospectively in untreated patients... CONCLUSION: Both agents were well tolerated. Pentostatin produced higher response rates, and the responses were durable. Patient age and clinical status had an impact on outcome with pentostatin. Pentostatin is effective therapy for hairy cell leukemia.
Effect of adenosine deaminase inhibition with pentostatin on myocardial stunning in dogs. [1995.03]
Pentostatin (2-deoxycoformycin) is a potent inhibitor of adenosine deaminase and has been demonstrated to augment endogenous adenosine levels during regional and global myocardial ischemia. Based on the rationale that increasing endogenous adenosine during ischemia may be cardioprotective, the objective of this study was to determine if adenosine deaminase inhibition with pentostatin could improve postischemic contractile dysfunction (stunning) in open-chest anesthetized dogs...
Clinical Trials Related to Nipent (Pentostatin)
Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant [Recruiting]
This clinical trial studies pentostatin and donor lymphocyte infusion in preventing graft
rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and
an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell
transplant may stop the patient's immune system from rejecting the donor's stem cells. The
donated stem cells may replace the patient's immune cells and help destroy any remaining
cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can
also make an immune response against the body's normal cells. Giving pentostatin before
donor lymphocyte infusion may stop this from happening
A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies [Recruiting]
This is a study to explore the use of a reduced intensity transplant conditioning regimen. A
conditioning regimen is the treatment that is given to prepare a body for the new bone
marrow that will be received from a donor. Reduced intensity conditioning uses lower doses
of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and
radiation cause fewer side effects. Reduced intensity regimens have been offered to older
patients or patients at increased risk for transplant-related side effects and have been
shown to be safe and effective. Reduced intensity conditioning regimens are now considered
for many patients who are undergoing transplant.
Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies [Recruiting]
The purpose of the study is to determine if participants who receive the GVHD prophylaxis
medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The
study is estimated to have sufficient statistical power to ascertain at least a 20%
improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin
Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma [Recruiting]
This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab
(PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell
Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal
dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how
safe these three drugs work together.
Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma [Recruiting]
RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells
and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy,
such as pentostatin and cyclophosphamide, work in different ways to stop the growth of
cancer cells, either by killing the cells or by stopping them from dividing. Giving
ofatumumab together with pentostatin and cyclophosphamide may be a better way to block
PURPOSE: This phase II trial is studying how well giving ofatumumab together with
pentostatin and cyclophosphamide works in treating patients with untreated chronic
lymphocytic leukemia or small lymphocytic lymphoma.
Reports of Suspected Nipent (Pentostatin) Side Effects
Confusional State (3),
Nuchal Rigidity (3),
Pericardial Effusion (3),
Fatigue (3), more >>
Page last updated: 2011-12-09