Clinical trial · Interventional
Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant
A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic 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): Enrollment on hold pending amendment
Summary
Brief summary (as posted)
This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of radiation therapy to the bone marrow that may be less toxic and may also reduce the chances of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Previously Treated Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Recurrent Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | — | UNRESOLVED |
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Fludarabine Phosphate | Drug | Fludarabine | ALIAS |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Peripheral Blood Stem Cell Transplantation | Procedure | — |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)
- description
- CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes daily on days -7 to -3 and melphalan IV on day -2. Patients also undergo IMTMI BID for 2 to 5 days between days -7 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT or BMT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO BID on days -2 to 180 with taper thereafter and mycophenolate mofetil IV every 8 hours or PO on days 0-28 (for matched donors) or days 0-40 (for alternative donors) with taper to day 60.
- interventionNames
- Drug: Fludarabine Phosphate
- Drug: Melphalan
- Radiation: Intensity-Modulated Radiation Therapy
- Radiation: Total Marrow Irradiation
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Procedure: Peripheral Blood Stem Cell Transplantation
- Procedure: Allogeneic Bone Marrow Transplantation
- Drug: Tacrolimus
- Drug: Mycophenolate Mofetil
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- MTD of conditioning regimen defined as any grade III or higher dose-limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with the following diseases: acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) undergoing second allogeneic (allo)-stem cell transplant (SCT) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL), will be at the discretion of the investigators * Karnofsky performance status of 70 or above * Life expectancy is not severely limited by concomitant illness * Adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (LVEF) =\< 40% or diffusion capacity of carbon monoxide (DLCO) =\< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol * Serum creatinine =\<1.5 mg/dL or creatinine clearance \> 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (PI) * Serum bilirubin =\< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI * Serum glutamic oxaloacetic transaminase (SGPT) \< 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the PI * No evidence of chronic active hepatitis or cirrhosis * Human immunodeficiency virus (HIV)-negative * Patient is not pregnant * Patient or guardian able to sign informed consent * DONOR: Since these patients already had first allo-SCT; in the majority time, the same matched donor has been used for second allo-SCT; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT; the donor could be matched related donors or matched unrelated donors from registry * DONOR: If more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (SOP): * Age of donor (18-24 \> 25-34 \> 35-44 \> 45+) * Sex of donor (male \> female, nulliparous female \> parous, multiparous female) * Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- \> CMV+
References
Publications (0)
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