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Preparation for bone marrow transplant through the combined use of chemo and radiotherapy (intensive or myeloablative: eliminates stem cells)
EU CTIS ID: 2024-514484-25-00
What this study is testing
The antitumor activity of the conditioning regimen with TMLI, cyclophosphamide and etoposide followed by AHSCT will be evaluated by means of the progression-free survival (PFS) at 2 years after a safety-lead phase.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant has the ability and willingness to sign the informed consent document
- 3. Pulmonary function tests: forced expiratory volume in one second (FEV1) and Carbon Monoxide Diffusion Capacity (DLCO) (adjusted for Hb) ≥ 50% from expected normal value
- Patients should undergo cardiac evaluation with an electrocardiogram showing no ischemic changes or clinically relevant arrhythmia, and a ≥50% ejection fraction established by Multi-Gated Acquisiton Scan (MUGA) or echocardiogram
- ECG showing no ischemic changes or clinically significant arrhythmia
- Men and women of childbearing potential agree to use appropriate contraceptives (hormonal or barrier contraception or abstinence) prior to study entry and for six months following the duration of study participation
- The time elapsed since the end of the last induction or reinduction cycle must be greater than or equal to 14 days
You likely can't join if
- Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded
- Subjects who, in the opinion of the investigator, may not be able to meet the safety control requirements of the study
- Previous radiation therapy, which would preclude the use of TMLI
- Plans during the trial to receive any other investigational (non-trial-related) agents
- Uncontrolled disease, including ongoing or active infection
- History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide
See the full eligibility criteria
Who can join
- The participant has the ability and willingness to sign the informed consent document
- 3. Pulmonary function tests: forced expiratory volume in one second (FEV1) and Carbon Monoxide Diffusion Capacity (DLCO) (adjusted for Hb) ≥ 50% from expected normal value
- Patients should undergo cardiac evaluation with an electrocardiogram showing no ischemic changes or clinically relevant arrhythmia, and a ≥50% ejection fraction established by Multi-Gated Acquisiton Scan (MUGA) or echocardiogram
- ECG showing no ischemic changes or clinically significant arrhythmia
- Men and women of childbearing potential agree to use appropriate contraceptives (hormonal or barrier contraception or abstinence) prior to study entry and for six months following the duration of study participation
- The time elapsed since the end of the last induction or reinduction cycle must be greater than or equal to 14 days
- Age ≥18 to ≤50 years
- Karnofsky’s performance status should be ≥70%
- Patients with myelodysplastic syndrome/acute myeloid leukemia or acute myeloid leukemia with relapsed/refractory active disease, or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing (in the case of FLT3-ITD-mutated AML)
- All candidates for this study must have an HLA (A, B, C, DR) identical siblings who are willing to donate bone marrow or peripheral blood hematopoietic progenitors or an 8/8 matched unrelated donor. A single allele mismatch in A, B, C or DRB1 shall be allowed
- Total bilirubin ≤ 1.5 x ULN OR 3 x ULN for Gilbert's disease
- SGOT & SGPT ≤ 5 x LSN
- Serum creatinine ≤ 1.3 mg/dL or creatinine clearance measured ≥ 80 mL/min for 24 hours of urine collection
- Women of childbearing age only: Negative urine or serum pregnancy test
What rules you out
- Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded
- Subjects who, in the opinion of the investigator, may not be able to meet the safety control requirements of the study
- Previous radiation therapy, which would preclude the use of TMLI
- Plans during the trial to receive any other investigational (non-trial-related) agents
- Uncontrolled disease, including ongoing or active infection
- History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide
- Patients with other active malignancies are not eligible for this study, other than the malignancies discussed
- Patients with a psychological or medical condition that the patient's physician deems unacceptable to proceed with allogeneic hematopoietic stem cell transplantation
- Women who plan to become pregnant or breastfeed during the trial
- Patients who do not agree to practice effective forms of contraception
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.