Clinical trial · Interventional
Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT
Treosulfan and Total-marrow Irradiation (TMI) Based Conditioning With Rapamycin Based Graft vs. Host Disease (GvHD) Prophylaxis for Allogenic Stem Cell Transplantation (Allo-HSCT) in Patients With High-risk Hematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low rate of enrolment
Summary
Brief summary (as posted)
TrRaMM-TMI is a phase I trial to evaluate the feasibility and efficacy of an original sequential TMI/TrRaMM (Total Marrow Irradiation/Treosulfan-Rapamycin-Mycophenolate Mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic Stem Cell Transplant (SCT). The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Vs Host Disease | — | UNRESOLVED | — |
| Irradiated Bone Marrow | — | UNRESOLVED | — |
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Transplant-Related Hematologic Malignancy | Transplant-Related Hematologic Malignancy | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conditioning treatment "Treosulfan-TMI" | Drug | — | UNRESOLVED |
| GvHD prophylaxis | Drug | — | UNRESOLVED |
| SCT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm Treatment
- description
- Conditioning treatment "Treosulfan+TMI"; SCT; GvHD prophylaxis;
- interventionNames
- Drug: Conditioning treatment "Treosulfan-TMI"
- Procedure: SCT
- Drug: GvHD prophylaxis
Primary outcomes (2)
- measure
- Evaluation of the maximum tolerated dose of TMI (FEASIBILITY of TMI)
- timeFrame
- From administration of TMI (-5) to transplant
- description
- To determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule
- measure
- Rate of Survival post transplant
- timeFrame
- +30 days post transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with haematological malignancies such as * any acute myeloid leukemia (AML) beyond Complete Remission (CR) 1 * any acute lymphoblastic leukemia (ALL) beyond CR1 * multiple myeloma (MM) at any relapse/progression, except refractory disease * MM with unfavourable cytogenetic profile at diagnosis * MM with less than a partial response (PR) after induction therapy * Karnofsky Index ≥ 80 % * Adequate contraception in female patients of child-bearing potential. * Written informed consent * Availability of one of the following: * A matched related or unrelated donor (MRD or MUD) Exclusion Criteria: * A hematopoietic cell transplantation-specific comorbidity index \> 4 * Active non-controlled infectious disease at the moment of inclusion * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Impaired liver function (Bilirubin \> 2.0 x upper normal limit; Transaminases \> 3.0 x upper normal limit) * Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit). * Pleural effusion or ascites \> 1.0 L * Pregnancy or lactation * Known hypersensitivity to treosulfan and/or fludarabine and/or rapamycin * Non-co-operative behaviour or non-compliance * Psychiatric diseases or conditions that might impair the ability to give informed consent * Previous spinal cord radiotherapy with dose ≥ 45 Gy equivalent
References
Publications (0)
Data not yet available