LEUKERAN (chlorambucil)
LEUKERAN is indicated for the treatment of Chronic Lymphocytic Leukemia; Lymphoma; Lymphosarcoma; Giant Follicular Lymphoma; Hodgkin's Disease.
How LEUKERAN Works
Chlorambucil is an aromatic nitrogen mustard derivative that acts as an alkylating agent. It interferes with DNA replication and induces cellular apoptosis through the accumulation of cytosolic p53 and the subsequent activation of Bax, a pro-apoptotic promoter.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1957-03-18
- Routes
- ORAL
- Dosage Forms
- TABLET
LEUKERAN Approval History
What LEUKERAN Treats
5 indicationsLEUKERAN is approved for 5 conditions since its original approval in 1957. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Lymphocytic Leukemia
- Lymphoma
- Lymphosarcoma
- Giant Follicular Lymphoma
- Hodgkin's Disease
LEUKERAN Boxed Warning
WARNING LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS)....
WARNING LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS).
LEUKERAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LEUKERAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LEUKERAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LEUKERAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03462719 GLOW results posted | CR108428 2017-004699-77, 54179060CLL3011 | Ph 3 | active not recruiting | A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT04075292 results posted | D822BC00001 | Ph 3 | active not recruiting | Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia |
| NCT01808599 | IELSG38 | Ph 2 | active not recruiting | Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma |
| NCT02242942 results posted | BO25323 2014-001810-24, CLL14 | Ph 3 | completed | Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia |
| NCT02475681 ElevateTN results posted | ACE-CL-007 2023-509348-84-00, 2014-005582-73 | Ph 3 | active not recruiting | Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL |
| NCT02612311 UNITY-CLL results posted | UTX-TGR-304 2015-005758-36 | Ph 3 | terminated | Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia |
| NCT06319456 | APG2575CC301 | Ph 3 | recruiting | A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. |
| NCT02336048 | BO29448 2014-004594-16 | Ph 1 | terminated | A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities |
| NCT01088048 results posted | 101-07 | Ph 1 | completed | Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia |
| NCT02264574 results posted | PCYC-1130-CA | Ph 3 | completed | A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) |
| NCT01905943 results posted | MO28543 2013-000087-29 | Ph 3 | completed | A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia |
| NCT00910910 ORIGIN results posted | CC-5013-CLL-008 2008-003079-32 | Ph 3 | completed | Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial) |
| NCT01283386 results posted | ML25137 | Ph 4 | terminated | A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status |
| NCT01980875 results posted | GS-US-312-0118 2013-004551-20 | Ph 3 | terminated | Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia |
| NCT02053610 results posted | BO21004 (Stage 2) 2009-012476-28; CLL1 | Ph 3 | completed | CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2) |
| NCT01998880 results posted | BO21004 (Stage 1b) 2009-012476-28; CLL1 | Ph 3 | completed | CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b) |
| NCT01010061 results posted | BO21004 (Stage 1a) 2009-012476-28; CLL11 | Ph 3 | completed | CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) |
| NCT01722487 results posted | PCYC-1115-CA 2012-003967-23 | Ph 3 | completed | Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL |
| NCT00738374 results posted | ML21445 2008-001612-20 | Ph 2 | completed | A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia. |
| NCT01868893 results posted | ML28979 | Ph 2 | completed | An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia |
| NCT01056510 results posted | MO22468 2009-012072-28 | Ph 4 | completed | A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe) |
| NCT01109264 | SIM-79-001 | Ph 2 | completed | Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEUKERAN FDA Label Details
Indications & Usage
FDA Label (PDF)LEUKERAN is indicated for the treatment of Chronic Lymphocytic Leukemia; Lymphoma; Lymphosarcoma; Giant Follicular Lymphoma; Hodgkin's Disease.
WARNING LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS)....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment