Summary
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Lymphocytic Leukaemia (CLL) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Lymphocytic Leukaemia (CLL). ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Chronic Lymphocytic Leukaemia (CLL): 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00281879). It plans or enrolled 200 participants. Registration activity spans 1998 to 2011. No published literature item is linked to Tacrolimus Anhydrous and Chronic Lymphocytic Leukaemia (CLL) 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 Chronic Lymphocytic Leukemia 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: Early-stage (Rai 0-I): watch-and-wait appropriate in 50-70%; spontaneous remission extremely rare; median time to treatment in Rai Stage 0: 10+ years; Richter's transformation (5-10%) extremely poor prognosis.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 39.5 (trials 19.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00143845 | Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant 2003 | completed | Phase 2 | 54 |
| NCT00004145 | Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer 1998 | completed | Phase 2 | 16 |
| NCT00448201 | Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease 2011 | completed | Phase 2 | 71 |
| NCT00589563 | Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer 2007 | completed | Phase 2 | 32 |
| NCT00057954 | Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma 2005 | terminated | Phase 2 | 6 |
| NCT00818961 | Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer 2005 | terminated | Phase 2 | 36 |
| NCT00281879 | Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer 2006 | terminated | Phase 2 | 200 |
| NCT00423826 | Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease 2007 | no_longer_available | Not applicable | — |
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 Tacrolimus Anhydrous approved for Chronic Lymphocytic Leukaemia (CLL)?
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Lymphocytic Leukaemia (CLL) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Lymphocytic Leukaemia (CLL). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus Anhydrous in clinical trials for Chronic Lymphocytic Leukaemia (CLL)?
ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Chronic Lymphocytic Leukaemia (CLL): 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00281879). It plans or enrolled 200 participants. Registration activity spans 1998 to 2011.
What does the evidence show for Tacrolimus Anhydrous in Chronic Lymphocytic Leukaemia (CLL)?
Tacrolimus Anhydrous has 4 completed registered trials for Chronic Lymphocytic Leukaemia (CLL) 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.