adenine and Leishmaniasis, Cutaneous

adenine has been researched along with Leishmaniasis, Cutaneous in 5 studies

Leishmaniasis, Cutaneous: An endemic disease that is characterized by the development of single or multiple localized lesions on exposed areas of skin that typically ulcerate. The disease has been divided into Old and New World forms. Old World leishmaniasis is separated into three distinct types according to epidemiology and clinical manifestations and is caused by species of the L. tropica and L. aethiopica complexes as well as by species of the L. major genus. New World leishmaniasis, also called American leishmaniasis, occurs in South and Central America and is caused by species of the L. mexicana or L. braziliensis complexes.

Research

Studies (5)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Assess the Response Rate of cGVHD to Treatment With Ibrutinib Plus Rituximab

Response rate of clinically significant GVHD will be assessed using NIH criteria (from 2014 NIH Consensus Development Project). (NCT03689894)
Timeframe: 6 weeks, 3 months, and 6 months after initiation of treatment

Number of Participants With Treatment Emergent Adverse Events (AEs)

Number of participants who had experienced at least one treatment emergent AE (NCT01217749)
Timeframe: From first dose of study treatment to within 30 days of last dose or until study closure

Percentage of Participants Achieving Response

The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results. (NCT01217749)
Timeframe: The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months

Progression Free Survival (PFS) at 12 Months

"Progressive disease for CLL (Hallek) is characterized by ≥1 of the following:~Appearance of any new lesion, eg lymph nodes (> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates~Increase of ≥50%~in longest diameter of any previous site~in hepatomegaly or splenomegaly~in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen~Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir:~Appearance of a new lesion(s) >1.5 cm in any axis, ≥ 50% increase in the SPD of >1 node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis~Lesions PET+ if FDG-avid lymphoma or PET+ before therapy~50% increase from nadir in the SPD of any liver or spleen lesions~New or recurrent BM involvement~Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen" (NCT01217749)
Timeframe: From first dose of study treatment until disease progression, death, or until 12 months

Safety During Dose-Limiting Toxicity (DLT) Observation Period

Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2 (NCT01217749)
Timeframe: 56 days for Group 1 and 28 days for Group 2

Food Effect Cohort Assessments

Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose. (NCT01105247)
Timeframe: Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.

Number of Participants With Treatment Emergent Adverse Events (AEs)

Number of participants who had experienced at least one treatment emergent AEs. (NCT01105247)
Timeframe: From first dose to within 30 days of last dose of PCI-32765

Percentage of Participants Achieving Response

Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. (NCT01105247)
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).

Progression Free Survival Rate at 24 Months

Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size. (NCT01105247)
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).

Trials

1 trial available for adenine and Leishmaniasis, Cutaneous

Other Studies

4 other studies available for adenine and Leishmaniasis, Cutaneous