Clinical trial · Interventional
Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
Secondary outcomes (3)
- measure
- Risk of severe graft-versus-host disease
- measure
- Kinetics of immune reconstitution
- measure
- Risk of life-threatening infections
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of a life-threatening hematologic malignancy, including any of the following:
* Acute leukemia advanced beyond first remission
* Acute leukemia in first remission\* with very high-risk prognostic features, including any of the following:
* Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)
* ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality
* Hypodiploid ALL
* Failed to achieve first remission within 1 month after induction therapy
* Secondary AML
* Myelodysplastic syndromes with International Prognostic Index score \> 1
* Chronic myelogenous leukemia in accelerated or blast phase NOTE: \*Must be approved by PCC
* Haploidentical family donor available
* No suitable HLA-matched related or unrelated donor available
* No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available
PATIENT CHARACTERISTICS:
Age
* Under 21
Performance status
* Not specified
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* SGPT and SGOT \< 2 times upper limit of normal (ULN)\*
* Bilirubin \< 2 times ULN\* NOTE: \*Unless due to malignancy
Renal
* Not specified
Cardiovascular
* Ejection fraction ≥ 45%
Pulmonary
* DLCO ≥ 60% of predicted
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No second bone marrow transplantation, after a first regimen containing total body irradiation
* No concurrent growth factors until day 21 post-transplantation
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* See Biologic therapy
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available