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Pentostatin

Phase 3

B-Cell Chronic Lymphocytic Leukemia | Small molecule | Oncology |McKesson Corporation|Last Updated: Nov 3, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment184

FDA Designations

No designations recorded

Clinical trial landscape

Pentostatin · 1 trial · 1 indication

Phase 3 1
NCT00254163Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia PatientsB-Cell Chronic Lymphocytic Leukemia
COMPLETED184 Analytics
PHASE3COMPLETED
Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients
B-Cell Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Infection Rate
6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

infection=febrile events requiring treatment

Secondary Endpoints

Infective Event Rate
6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
Percentage of Patients Hospitalized
6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
Hematologic Recovery
2 months post-treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fludarabine, Cyclophosphamide, and RituximabACTIVE_COMPARATORFludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)
Pentostatin, Cyclophosphamide, and RituximabEXPERIMENTALPentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)

Interventions

NameTypeDescription
FludarabineDRUG -
CyclophosphamideDRUG -
RituximabDRUG -
PentostatinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

INCLUSION CRITERIA: Patients will be eligible for inclusion in this study if they meet all of the following criteria: * Progressive, histologically proven B-cell CLL. * Stage II, III, or IV B-cell CLL, as defined by Appendix III. Note: The pathology or flow cytometry (of peripheral blood or a bon...

Countries:United States
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Frequently asked questions about Pentostatin

What is Pentostatin used for in B-Cell Chronic Lymphocytic Leukemia?

Pentostatin is a small molecule being studied for the treatment of B-Cell Chronic Lymphocytic Leukemia. It is administered in combination with cyclophosphamide and rituximab, and is being evaluated against a regimen of fludarabine, cyclophosphamide, and rituximab in patients with previously untreated or treated disease.

Who makes Pentostatin?

Pentostatin is being developed by McKesson Corporation, which trades under the ticker symbol MCK. The company is conducting clinical research on this drug for B-Cell Chronic Lymphocytic Leukemia.

What phase is Pentostatin in?

Pentostatin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 trial has been completed, evaluating its efficacy and safety in patients with B-Cell Chronic Lymphocytic Leukemia.

What clinical trials is Pentostatin in?

Pentostatin has one completed Phase 3 trial, NCT00254163, which enrolled 184 participants in the United States. The trial compared pentostatin, cyclophosphamide, and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with B-Cell Chronic Lymphocytic Leukemia.

How does Pentostatin work?

Pentostatin is a small molecule that works by inhibiting the enzyme adenosine deaminase, which is essential for the proliferation of lymphocytes. By blocking this enzyme, pentostatin disrupts DNA synthesis and leads to the death of cancerous B-cells, making it effective in treating B-Cell Chronic Lymphocytic Leukemia.

Is Pentostatin the same as other drugs?

Pentostatin is a distinct drug and is not the same as fludarabine, which is used as a comparator in its clinical trial. While both are used in B-Cell Chronic Lymphocytic Leukemia, they have different mechanisms of action and are not interchangeable.