Drugs / Chlorambucil
Chlorambucil
also known as
Ambochlorin · CB-1348 · Chlorambucil: Leukeran · Chlorambucilum · Clorambucilo · Ecloril · Leukeran · Lympholysin · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LEUKERAN | — | 1957-03-18 | fda.gov ↗ |
Trials 29
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News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | AbbVie | Results AbbVie Presents New Data at EHA 2026 Congress for VENCLEXTA®/VENCLYXTO® (venetoclax) in First-Line Chronic Lymphocytic Leukemia Highlighting Long-Term Treatment Outcomes for Patients: Nine-Year Results abbvie.com ↗
Venetoclax in combination with obinutuzumab has shown positive responses across several key measures compared to obinutuzumab plus chlorambucil, including an extended increase in progression-free survival in previously untreated patients with chronic lymphocytic leukemia, |
| 2024-06-14 | Janssen Research & Development, LLC | Results Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA® (ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up jnj.com ↗
With up to ten years of follow-up, patients treated with ibrutinib demonstrated a significant and sustained progression-free survival (PFS) benefit versus patients treated with chlorambucil. |
| 2023-06-09 | AbbVie | Results AbbVie's VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) Patients abbvie.com ↗
Six-year median follow-up from the Phase 3 CLL14 study shows continued PFS after treatment with venetoclax plus obinutuzumab compared to treatment with chlorambucil plus obinutuzumab in previously untreated patients with CLL and co-existing conditions |
| 2022-06-10 | Hoffmann-La Roche | Results Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting roche.com ↗
The estimated investigator-assessed progression-free survival (PFS) rate at this follow-up was 62.6% with Venclexta/Venclyxto plus Gazyva/Gazyvaro and 27.0% with Gazyva/Gazyvaro plus chlorambucil, and the estimated overall survival (OS) rate was 81.9% versus 77.0% (HR 0.72; 95% CI: 0.48-1.09; p=0.12). |
| 2022-06-10 | AbbVie | Results New Data Demonstrates AbbVie's VENCLYXTO®/VENCLEXTA® Combination Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients After Four Years Off Treatment abbvie.com ↗
PFS was significantly superior for venetoclax plus obinutuzumab compared to chlorambucil plus obinutuzumab (median not reached [NR] vs. 36.4 months, p<0.0001) |
| 2022-06-04 | AstraZeneca | Results Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line chronic lymphocytic leukaemia with 90% of patients surviving five years in ELEVATE-TN trial astrazeneca.com ↗
An estimated 90% of patients treated with the Calquence combination were alive at five years versus 84% for Calquence alone and 82% for chlorambucil plus obinutuzumab. |
| 2021-12-11 | Janssen Research & Development, LLC | Results New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia jnj.com ↗
New secondary endpoint data from the Phase 3 GLOW study (NCT03462719) showed that fixed-duration treatment with I+V resulted in undetectable minimal residual disease (uMRD) responses that were deeper compared to patients treated with chlorambucil plus obinutuzumab |
| 2021-06-12 | Janssen Research & Development, LLC | Results New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗
The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission. |
| 2021-06-12 | Janssen Research & Development, LLC | Results New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2021-06-12 | AbbVie | Results IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study abbvie.com ↗
The PFS benefit with I+V was consistent across pre-specified subgroups, including patients 65 years and older and those with comorbidities (CIRS >6). |
| 2021-06-11 | Hoffmann-La Roche | Results Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia roche.com ↗
The fixed treatment duration (12 months) study indicated that the chemotherapy-free Venclexta/Venclyxto plus Gazyva/Gazyvaro (obinutuzumab) regimen had an estimated PFS rate of 74.0% vs 35.4% for Gazyva/Gazyvaro plus chlorambucil. |
| 2021-06-11 | AbbVie | Results New Data Shows AbbVie's VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment abbvie.com ↗
At four years after randomization, the PFS rate for patients treated with the VENCLYXTO/VENCLEXTA-based combination was 74 percent compared to 35.4 percent for patients treated with obinutuzumab and chlorambucil. |
| 2021-06-10 | Genentech, Inc. | Results Genentech Announces Data at EHA2021 Reinforcing Efficacy of Venclexta Combinations in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia gene.com ↗
The fixed treatment duration (12 months) study indicated that the chemotherapy-free Venclexta plus Gazyva® (obinutuzumab) regimen had an estimated PFS rate of 74.0% vs 35.4% for Gazyva plus chlorambucil. |
| 2021-06-04 | AbbVie | Results Results from IMBRUVICA® (ibrutinib) RESONATE-2 Study Provide Up to Seven Years of Progression-Free and Overall Survival Data in First-Line Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
AbbVie (NYSE: ABBV), today announced extended long-term data from the Phase 3 RESONATE-2 study ( PCYC-1115/1116 ) evaluating single-agent IMBRUVICA (ibrutinib) versus chlorambucil with up to seven years of follow-up in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). |
| 2020-12-06 | AbbVie | Results Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients abbvie.com ↗
At 42 months, PFS rates were higher across high-risk genomic subgroups in patients treated with IMBRUVICA (63 to 82 percent) compared to those receiving chlorambucil with or without obinutuzumab (6 to 34 percent) |
| 2020-12-05 | Hoffmann-La Roche | Results Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia roche.com ↗
In this analysis, after treatment with fixed-duration Venclexta/Venclyxto plus Gazyva/Gazyvaro, the estimated clonal growth rate was slower and lower, suggesting more effective MRD eradication in these patients compared to those treated with Gazyva/Gazyvaro plus chlorambucil. |
| 2020-12-05 | Genentech, Inc. | Results Genentech Announces New Data Reinforcing the Long-Term Benefit of Venclexta-Based Combination for People With Relapsed or Refractory Chronic Lymphocytic Leukemia gene.com ↗
In this analysis, after treatment with fixed-duration Venclexta plus Gazyva, the estimated clonal growth rate was slower and lower, suggesting more effective MRD eradication in these patients compared to those treated with Gazyva plus chlorambucil. |
| 2020-12-05 | AbbVie | Results AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
The four-year, follow-up analysis showed an OS rate of 85.3% with Ven-Obi versus 83.1% with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; P=0.4929). |
| 2019-12-08 | Hoffmann-La Roche | Results New data demonstrate the continued clinical benefit of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based treatments in chronic lymphocytic leukaemia roche.com ↗
Higher rates of MRD-negativity in peripheral blood (76% vs. 35%; p<0.001) and bone marrow (57% vs. 17; p<0.001%) were observed at the end of treatment in people treated with Venclexta/Venclyxto plus Gazyva/Gazyvaro versus Gazyva/Gazyvaro plus chlorambucil, respectively. |
| 2019-12-08 | Genentech, Inc. | Results New Data Demonstrate the Continued Clinical Benefit of Fixed-duration, Chemotherapy-free Venclexta-based Treatments in Chronic Lymphocytic Leukemia gene.com ↗
Higher rates of MRD-negativity in peripheral blood (76 percent vs. 35 percent; p<0.001) and bone marrow (57 percent vs. 17 percent; p<0.001) were observed at the end of treatment in people treated with Venclexta plus Gazyva versus Gazyva plus chlorambucil, respectively. |
| 2019-12-07 | AstraZeneca | Results Calquence significantly prolonged the time patients lived without disease progression or death in previously untreated chronic lymphocytic leukaemia astrazeneca.com ↗
Full results from the Phase III ELEVATE TN trial showed 93% of patients on Calquence combined with obinutuzumab vs. 47% of patients on chlorambucil plus obinutuzumab remained free of disease progression or death at 24 months |
| 2019-06-06 | AstraZeneca | Results Calquence Phase III ELEVATE-TN trial met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukaemia astrazeneca.com ↗
The trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. |
| 2019-06-04 | Hoffmann-La Roche | Results Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine roche.com ↗
Venclexta/Venclyxto plus Gazyva/Gazyvaro showed improvements across multiple efficacy measures compared to Gazyva/Gazyvaro plus chlorambucil, including progression-free survival and deep remissions as determined by minimal residual disease measurement |
| 2019-06-04 | Genentech, Inc. | Results Pivotal Phase III CLL14 Results for Venclexta in Combination With Gazyva for Chronic Lymphocytic Leukemia Presented at ASCO 2019 and Published in the New England Journal of Medicine gene.com ↗
At two years, one year after stopping treatment, nearly nine out of ten patients (88.2 percent) in the Venclexta plus Gazyva arm remained progression-free, compared to 64.1 percent in the Gazyva plus chlorambucil arm. |
| 2019-06-04 | AbbVie | Results AbbVie Presents Data from Venetoclax Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia abbvie.com ↗
The results demonstrate that venetoclax plus obinutuzumab prolonged progression-free survival (PFS) and achieved higher rates of complete response and minimal residual disease (MRD)-negativity compared to a commonly used standard of care obinutuzumab plus chlorambucil. |
| 2018-11-01 | Hoffmann-La Roche | Results Phase III data showed that Venclexta/Venclyxto plus Gazyva/Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities roche.com ↗ |
| 2018-10-31 | AbbVie | Results AbbVie Announces Positive Results from CLL14, a Phase 3 Trial Evaluating a Venetoclax Combination as First-Line Therapy with a Fixed Duration of Treatment in Patients with Chronic Lymphocytic Leukemia abbvie.com ↗
The study met its primary endpoint of investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death 1 ) with a 12-month fixed duration of treatment. |
| 2018-06-15 | Hoffmann-La Roche | Results New long-term data confirm Roche's Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan roche.com ↗
After a follow-up of nearly five years, final results showed clinically meaningful improvements with Gazyva/Gazyvaro plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with MabThera®/Rituxan® (rituximab) plus chlorambucil. |
| 2018-05-24 | AbbVie | Results IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint abbvie.com ↗
Specifically, the study met its primary endpoint for a clinically and statistically significant difference in PFS for patients treated with IMBRUVICA plus obinutuzumab versus those who received chlorambucil plus obinutuzumab, as assessed by an Independent Review Committee (IRC). |
| 2017-12-09 | AbbVie | Results IMBRUVICA® (ibrutinib) Patient-Reported Outcomes Data Detail Long-Term Improvement in Treatment Outcomes and Quality of Life Experience in Chronic Lymphocytic Leukemia (CLL) Patients abbvie.com ↗
At 30 months, ibrutinib was also associated with a greater progression-free survival (PFS) rate of 85 percent versus chlorambucil, which had a PFS rate of 28 percent. |
| 2016-12-03 | AbbVie | Results IMBRUVICA® (ibrutinib) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma 5-Year Analysis and Long-Term RESONATE-2 Follow-up Data at ASH 2016 Show Lasting Efficacy abbvie.com ↗
At 24 months, PFS was 89% for patients taking IMBRUVICA and 34% for chlorambucil (HR= 0.121; 95% CI (0.074-0.198); p<0.0001). |
| 2015-12-05 | Genentech, Inc. | Results New Results from CLL11 Study Show Gazyva® Provided People with Previously Untreated Chronic Lymphocytic Leukemia a Treatment-free Period of Nearly Four Years gene.com ↗
New Results from CLL11 Study Show Gazyva® Provided People with Previously Untreated Chronic Lymphocytic Leukemia a Treatment-free Period of Nearly Four Years |
| 2015-04-15 | Novartis Pharmaceuticals | Results Data in The Lancet show Novartis drug Arzerra® plus chlorambucil improved median progression-free survival by 71% in CLL patients novartis.com ↗ |
| 2013-05-29 | GlaxoSmithKline | Results GSK and Genmab announce positive top-line results from pivotal trial of ARZERRA® (ofatumumab) combined with chlorambucil in previously untreated chronic lymphocytic leukaemia gsk.com ↗
A 9.3 month improvement in the time a patient lived without worsening of their disease (median PFS) was seen in patients randomised to ofatumumab and chlorambucil compared to patients randomised to chlorambucil alone (22.4 months vs 13.1 months; HR: 0.57; p<0.001). |
All press releases naming this drug 36 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Chlorambucil | “Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days” NCT00117598 ↗53“Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine” NCT00875667 ↗ “Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.” NCT04578613 ↗ “azathioprine chlorambucil (Leukeran)” NCT00132691 ↗ “Carmustine, Chlorambucil, Cisplatin” NCT02788201 ↗ |
| Known as | Ambochlorin | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | CB-1348 | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Chlorambucil: Leukeran | “Chlorambucil: Leukeran” NCT02100852 ↗ |
| Known as | Chlorambucilum | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Clorambucilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Ecloril | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Leukeran | “azathioprine chlorambucil (Leukeran)” NCT00132691 ↗ |
| Known as | Lympholysin | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | NCI-3088 | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | NSC-3088 | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Modality | Other / unclassified | “An alkylating agent (cyclophosphamide or chlorambucil) combined with a corticosteroid regimen” PMID 34778952 ↗ Nov 2021 |
| Route | Oral | “Patients receive oral chlorambucil, procarbazine, and prednisolone on days 1-14;” NCT00003421 ↗ |