Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Non-Hodgkin Lymphoma (NHL) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Non-Hodgkin Lymphoma (NHL). ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Non-Hodgkin Lymphoma (NHL): 1 is active or not yet recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00516412). The largest enrolment is 243 participants (NCT01367457). Registration activity spans 2007 to 2013. No published literature item is linked to Sirolimus and Non-Hodgkin Lymphoma (NHL) in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Non-Hodgkin Lymphoma ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Indolent NHL (follicular): spontaneous remission in 20-30% of early-stage, allowing watch-and-wait; aggressive NHL (DLBCL): rapidly lethal without treatment in weeks-months.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 42.0 (trials 22.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ABL1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00516412 | Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma 2007 | completed | Phase 2 | 35 |
| NCT01244906 | Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant 2010 | completed | Phase 2 | 26 |
| NCT01334502 | Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma 2012 | completed | Phase 1 | 26 |
| NCT01535989 | Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma 2011 | completed | Phase 1 | 25 |
| NCT00671112 | Everolimus and Bortezomib in Treating Patients With Relapsed or Refractory Lymphoma 2008 | terminated | Phase 1 | 30 |
| NCT02061800 | CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant 2013 | active, not recruiting | PHASE1, PHASE2 | 14 |
| NCT01367457 | INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus 2011 | completed | Not applicable | 243 |
| NCT01076543 | Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma 2010 | completed | PHASE1, PHASE2 | 110 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ABL1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Non-Hodgkin Lymphoma (NHL)?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Non-Hodgkin Lymphoma (NHL) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Non-Hodgkin Lymphoma (NHL). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Non-Hodgkin Lymphoma (NHL)?
ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Non-Hodgkin Lymphoma (NHL): 1 is active or not yet recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00516412). The largest enrolment is 243 participants (NCT01367457). Registration activity spans 2007 to 2013.
What does the evidence show for Sirolimus in Non-Hodgkin Lymphoma (NHL)?
Sirolimus has 6 completed registered trials for Non-Hodgkin Lymphoma (NHL) but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ABL1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.