Busulfan in Acute Myeloid Leukemia: NCT07762508 Clinical Landscape Report 2026

11 September 2026
9 min read

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 11 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Not Applicable

Clinical phase

Not yet recruiting

Recruitment status

42

Planned enrollment

2029-07-01

Primary-completion proxy

Executive view

NCT07762508 evaluates Busulfan in Acute Myeloid Leukemia. The disclosed sponsor is The First Affiliated Hospital of Soochow University, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is 2-Year Overall Survival (OS), assessed over 2 years.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07762508 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Acute Myeloid Leukemia landscape. Drug & Asset MCP drug_fetch was queried for Busulfan, while Company & Deal Intelligence MCP organization_fetch was queried for The First Affiliated Hospital of Soochow University.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07762508BusulfanNot Applicable / Not yet recruitingThe First Affiliated Hospital of Soochow UniversityChina2-Year Overall Survival (OS)
2 years
2029-07-01
NCT07813390LisaftoclaxPhase 2 / Enrolling by invitationGuangdong General HospitalChinaOverall Response Rate After Two Cycles of HLA Therapy
At the end of Cycle 2 (each cycle is 28 days; approximately Day 56)
2027-09-01
NCT07814339Decitabine/CedazuridinePhase 1 / Not yet recruitingRutgers State University of New JerseyGeography not reportedPhase I - Primary Endpoint
8 to 12 months
2028-06-01
NCT07809906ORM-1153Phase 1 / Not yet recruitingOrum Therapeutics USA, Inc.United StatesOptimal Biological Dose(s) of ORM-1153
Approximately 24 months
2028-12-01
NCT07766850HydroxycarbamidePhase 1/2 / Not yet recruitingRegion StockholmSweden1-year EFS
From initiation of study treatment to the first occurrence of treatme…
2029-06-01

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07762508 is a Not Applicable, not yet recruiting study with 42 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “2-Year Overall Survival (OS)” over “2 years.” The retrieved endpoint description is: Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the end of follow-up will be censored at their last known alive date..

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 42 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

5 recent result records were selected as contextual evidence for Acute Myeloid Leukemia. These records do not establish direct evidence for NCT07762508 unless the registration number matches.

Vyxeos for Induction of Newly Diagnosed Low- or Intermediate-risk AML Patients, Age 18-70. A Pilot Study

Phase 2; n=20; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 6 Participants ; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 13 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05599360

A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia

Phase 2; n=21; CR = 8 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT04269213

AAML1831: A Phase III Trial Comparing Standard Induction Therapy With CPX-351 in De Novo Pediatric AML: A Report From the Children's Oncology Group

Phase 3; n=721; EFS(2-year) = 62.2 % ; EFS(2-year) = 51.2 % Source: https://pubmed.ncbi.nlm.nih.gov/42497367/

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Busulfan is indexed as Small molecule drug with DNA biology and a global stage of Approved. The asset profile lists Orphan Medical, Inc. as an originator or developer.

No exact Company & Deal Intelligence profile was returned for The First Affiliated Hospital of Soochow University. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

  1. Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether Busulfan is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07762508
Protocol source: https://clinicaltrials.gov/study/NCT07762508
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 11 September 2026.

Busulfan in Acute Myeloid Leukemia is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes 2-Year Overall Survival (OS) and 2029-07-01 the leading decision points.

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