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Consolidation Cycle A6
Consolidation Cycle A6 is a Small molecule drug developed by Nationwide Children's Hospital. It is currently in Phase 3 development for Acute lymphoblastic leukemia (ALL) in pediatric patients — consolidation phase treatment.
Consolidation Cycle A6 is a chemotherapy regimen used in pediatric acute lymphoblastic leukemia (ALL) treatment to eliminate residual leukemic cells after initial induction therapy.
Consolidation Cycle A6 is a chemotherapy regimen used in pediatric acute lymphoblastic leukemia (ALL) treatment to eliminate residual leukemic cells after initial induction therapy. Used for Acute lymphoblastic leukemia (ALL) in pediatric patients — consolidation phase treatment.
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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 | Consolidation Cycle A6 |
|---|---|
| Sponsor | Nationwide Children's Hospital |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This is a multi-drug consolidation chemotherapy cycle administered as part of a structured ALL treatment protocol. Consolidation cycles are designed to target and eliminate leukemic blasts that may remain after induction therapy, using combinations of cytotoxic agents to prevent relapse and improve long-term survival outcomes in pediatric patients.
Approved indications
- Acute lymphoblastic leukemia (ALL) in pediatric patients — consolidation phase treatment
Common side effects
- Myelosuppression
- Infection
- Nausea and vomiting
- Mucositis
- Hepatotoxicity
Key clinical trials
- Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma (PHASE3)
- A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (PHASE1, PHASE2)
- Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015) (NA)
- 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma (PHASE2)
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:
- Consolidation Cycle A6 CI brief — competitive landscape report
- Consolidation Cycle A6 updates RSS · CI watch RSS
- Nationwide Children's Hospital portfolio CI
Frequently asked questions about Consolidation Cycle A6
What is Consolidation Cycle A6?
How does Consolidation Cycle A6 work?
What is Consolidation Cycle A6 used for?
Who makes Consolidation Cycle A6?
What development phase is Consolidation Cycle A6 in?
What are the side effects of Consolidation Cycle A6?
Related
- Manufacturer: Nationwide Children's Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute lymphoblastic leukemia (ALL) in pediatric patients — consolidation phase treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing