Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma (SIR-MO-1101)
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|ClinicalTrials.gov Identifier: NCT01658007|
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 6, 2012
Last Update Posted : September 14, 2020
The investigators want to learn about treating relapsed/refractory lymphoblastic leukemia and lymphoma with a drug called sirolimus. The investigators are using sirolimus along with other cancer drugs that are often given to patients with relapsed leukemia and lymphoma.
The main purpose of this study is to determine if sirolimus can be given safely in combination with standard drugs used to treat relapsed lymphoblastic leukemia/lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Lymphoblastic Leukemia Recurrent Adult Lymphoblastic Lymphoma Refractory Acute Lymphoblastic Leukemia Refractory Lymphoblastic Lymphoma||Drug: Sirolimus||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Adding sirolimus to established induction and consolidation chemotherapy for relapsed/refractory acute lymphoblastic leuk
Adding sirolimus to established induction and consolidation chemotherapy for relapsed/refractory acute lymphoblastic leukemia
Other Name: Rapamycin, Rapamune
- Determine rate of dose limiting toxicities [ Time Frame: 35 days ]The safety of the regimen will be assessed by the occurrence of unexpected or severe adverse events attributable to sirolimus
- Number of participants with adverse events to determine maximum tolerated level of sirolimus in combination with chemotherapy [ Time Frame: 28 Days ]MAST (maximum acceptable sirolimus trough) will be the serum trough range at which fewer than one third of patients experience dose limiting toxicities during the observation period (28 days)
- Measure the number of residual leukemia cells in the bone marrow. [ Time Frame: At day 35 of induction and day 56 of consolidation ]Disease response will be assessed according to standard criteria
- Measure protein phosphorylation [ Time Frame: Samples collected at Baseline, Days 1, 3, 8 and 29 of induction and Baseline, and Days 1, 8, 29, and 36. ]Peripheral blood samples (5mL) will be obtained at day -6 (baseline), 1, 3,8, 29 of induction and day -6 (baseline), 1, 8, 29, 36 of consolidation for measurement of pAKT, p-S6, p70S6 kinase activity, and single-cell phosphoflow studies in peripheral blood mononuclear cells
- Tumor measurement by PET and/or CT scan [ Time Frame: After day 35 of induction and/or Day 56 of Consolidation ]Disease response will be assessed according to standard criteria
- Measure changes in sirolimus plasma concentration (ng/ml). [ Time Frame: 56 Days ]Use serial measurements of sirolmus trough levels and PK modeling to adjust individual patient sirolimus dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658007
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Maureen O'Brien, MD||Children's Hospital Medical Center, Cincinnati|