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NCT06602323: TMLI-RI
TMLI/Fludarabine/Melphalan Conditioning for Allogeneic Transplantation in High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia.
Phase 2 trial testing TMLI/Flu/Mel in Myelodysplastic Syndromes in 34 participants. Not yet recruiting.
1 October 2028
Quick facts
| Lead sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 1 October 2024 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 October 2028 |
Drugs / interventions tested
- TMLI/Flu/Mel
Conditions studied
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full company profile →
Who can join
Adults 50 to 99, any sex, with Myelodysplastic Syndromes or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn if drugs (fludarabine and melphalan) combinated with a targeted irradiation (in bone marrow and in lymphoid tissue) works to treat blood cancers (high risk myelodysplastic syndrome or acute myeloid leukemia) in adults. It will also learn about the safety of this combination of drugs and irradiation. The main questions it aims to answer are: * Does this combined therapy result in an improved survival and decreased relapse/progression rate after a bone marrow transplant? * What toxicities or complications do participants have when taking this combined therapy? Researchers will use this combined therapy to see if it works to treat high risk myelodysplastic syndrome or acute myeloid leukemia through the evaluation of the length of time (during the treatment and 2 years after the treatment) that a patient lives with the disease but it does not get worse (progression-free survival). Participants will: * Receive the combined therapy (study treatment) one week before the bone marrow transplant. * Receive too post-transplant medication as per usual clinical practice. Patients will have to attend medical visits (checkups and tests) for 2 years.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06602323
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06602323 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06602323.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing