Last reviewed · How we verify
A arm (CLAG-M)
A arm (CLAG-M) is a Multi-agent chemotherapy regimen Small molecule drug developed by Polish Adult Leukemia Group. It is currently in Phase 3 development for Acute myeloid leukemia (AML), particularly in relapsed/refractory or elderly patients. Also known as: Cladribine, Cytarabine, Mitoxantrone, G-CSF.
CLAG-M is a chemotherapy regimen combining cladribine, cytarabine, and mitoxantrone designed to induce remission in acute myeloid leukemia.
CLAG-M is a chemotherapy regimen combining cladribine, cytarabine, and mitoxantrone designed to induce remission in acute myeloid leukemia. Used for Acute myeloid leukemia (AML), particularly in relapsed/refractory or elderly patients.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | A arm (CLAG-M) |
|---|---|
| Also known as | Cladribine, Cytarabine, Mitoxantrone, G-CSF |
| Sponsor | Polish Adult Leukemia Group |
| Drug class | Multi-agent chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CLAG-M is a multi-agent induction chemotherapy regimen used primarily in acute myeloid leukemia (AML). Cladribine is a purine analog that inhibits DNA synthesis, cytarabine is a cytidine analog that disrupts DNA replication, and mitoxantrone is a topoisomerase II inhibitor. Together, these agents work synergistically to kill leukemic blasts and induce complete remission.
Approved indications
- Acute myeloid leukemia (AML), particularly in relapsed/refractory or elderly patients
Common side effects
- Myelosuppression/neutropenia
- Thrombocytopenia
- Anemia
- Infection
- Mucositis
- Nausea/vomiting
- Cardiotoxicity
Key clinical trials
- CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia (PHASE1)
- CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients (PHASE2)
- Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients with Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) (PHASE2)
- A PALG Prospective Multicenter Clinical Trial to Compare the Efficacy of Two Standard Induction Therapies (DA-90 vs DAC) and Two Standard Salvage Regimens (FLAG-IDA vs CLAG-M) in AML Patients ≤ 60 Years Old (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- A arm (CLAG-M) CI brief — competitive landscape report
- A arm (CLAG-M) updates RSS · CI watch RSS
- Polish Adult Leukemia Group portfolio CI
Frequently asked questions about A arm (CLAG-M)
What is A arm (CLAG-M)?
How does A arm (CLAG-M) work?
What is A arm (CLAG-M) used for?
Who makes A arm (CLAG-M)?
Is A arm (CLAG-M) also known as anything else?
What drug class is A arm (CLAG-M) in?
What development phase is A arm (CLAG-M) in?
What are the side effects of A arm (CLAG-M)?
Related
- Drug class: All Multi-agent chemotherapy regimen drugs
- Manufacturer: Polish Adult Leukemia Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia (AML), particularly in relapsed/refractory or elderly patients
- Also known as: Cladribine, Cytarabine, Mitoxantrone, G-CSF
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing