CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Sirolimus and Methotrexatedrug
Likely dose
Sirolimus and Methotrexate 20 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01162551
NCT01162551Phase 2Completed
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Phase 2 Trial of Sirolimus and Methotrexate in Relapsed/Refractory Lymphoblastic Leukemia and Lymphoma

Children's Hospital of Philadelphia·interventional·Posted Jul 14, 2010·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating Sirolimus and Methotrexate for Cancer and 2 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This is a phase 2 study looking at efficacy and toxicity of oral sirolimus in combination with oral methotrexate in children with refractory/relapsed ALL or NHL. Secondary objectives include characterizing the trough levels produced by administration of oral sirolimus in children with refractory/relapsed ALL/NHL and to evaluate the effect of sirolimus on intracellular targets related to mTOR inhibition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Leukemia, Lymphoma
CountriesUnited States
CollaboratorsThe Leukemia and Lymphoma Society

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2010
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.0 years ago

Interventions

Sirolimus and Methotrexatedrug

Single Arm Efficacy Trial: Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly. Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23. One cycle is 28 days.