Clinical trial · Interventional
Total Marrow and Total Lymph Node Irradiation, Fludarabine, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Hematological Cancer That Has Not Responded to Treatment
Phase I Study of Escalating Doses of Radiation Therapy Using Helical Tomotherapy in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With Advanced and Hematological Malignancies Who Are Not Eligible for Fully Myeloablative Regimen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol objective could not be met. A new study with amended eligibility criteria will be developed.
Summary
Brief summary (as posted)
RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and total lymph node irradiation when given together with fludarabine and melphalan followed by donor stem cell transplant in treating patients with advanced hematological cancer that has not responded to treatment.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| tomotherapy | Radiation | — | UNRESOLVED |
| total marrow irradiation | Radiation | — | UNRESOLVED |
| total nodal irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy
- measure
- Toxicity
Secondary outcomes (6)
- measure
- Frequency of clinical response
- measure
- Frequency of primary and secondary engraftment failure
- measure
- Time to neutrophil and platelet engraftment
- measure
- Incidence of acute and chronic graft-versus-host disease
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histopathologically confirmed diagnosis of 1 of the following:
* Acute myeloid leukemia (AML)
* Myelodysplastic syndromes
* Intermediate- or high-risk disease
* Myelofibrosis
* Granulocytic sarcoma (chloroma)
* With or without bone marrow involvement
* Mixed lineage leukemia
* Induction therapy must have been directed predominantly against AML
* Acute lymphoblastic leukemia
* Non-Hodgkin lymphoma
* Multiple myeloma
* Relapsed or refractory disease with M3 marrow (marrow blasts \> 25%), meeting 1 of the following criteria:
* Persistent disease after an induction attempt
* Persistent initial disease after two induction attempts
* Relapse after one re-induction attempt (second relapse)
* Persistent disease after first relapse and initial re-induction attempt
* Not eligible for myeloablative allogeneic hematopoietic stem cell transplantation due to age (\> 50 years), organ insufficiency, or significant comorbidity
* Patients 16-50 years of age must meet ≥ 1 of the following criteria:
* Ejection fraction 50-60% by MUGA scan and/or echocardiogram
* DLCO 50-75% of predicted
* Creatinine clearance or GFR 60-80 mL/min
* Serum bilirubin ≤ 2.0 mg/dL
* SGOT and SGPT 1.5-5 times upper limit of normal
* No other medical and/or psychosocial problem that, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from study regimen
* No Fanconi anemia
* HLA-identical sibling OR matched unrelated donor available
PATIENT CHARACTERISTICS:
* Zubrod or Karnofsky performance status 70-100%
* Negative pregnancy test
* Able to lie supine in a full body cast for 30 minutes
* No HIV infection
* No evidence of active hepatitis B or C infection
* No evidence of cirrhosis
* No uncontrolled viral, bacterial, or fungal infection within the past 4 weeks
* No radiographic changes indicating pulmonary disease (e.g., pulmonary nodules, infiltrates, or pleural effusion) unless cleared by pulmonary biopsy that shows no evidence of active pulmonary disease
* No major medical or psychiatric disorder that would seriously compromise patient tolerance of study regimen
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiation therapyReferences
Publications (0)
Data not yet available