NCT00544466Active, not recruitingPhase 1/2
Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies
Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving HT together with fludarabine phosphate and melphalan before a transplant may stop this from happening. PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and melphalan followed by donor stem cell transplant in treating patients with hematologic malignancies.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 13 Oct 2007
- Start date
- 31 Jul 2006
- Primary completion date
- 1 Aug 2013
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Acute lymphoblastic leukaemia, Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT00544466
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 75
- From 31 Jul 2006 to the primary completion date, 1 Aug 2013
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy
Other illness
- Major medical or psychiatric disorders that would seriously compromise patient tolerance of this regimen
- Human immunodeficiency virus (HIV) infection
- Evidence of Hepatitis B or C infection or evidence of cirrhosis
- Uncontrolled viral, bacterial or fungal infection
- Patients with recent (within 4 weeks) serious viral, fungal, or bacterial infection are excluded
- Patients with radiographic changes indicating pulmonary disease, including but not limited to: pulmonary nodules, infiltrates, pleural effusion are excluded unless cleared by pulmonary biopsy showing no evidence for active pulmonary disease
Other
- Patients with Acute Undifferentiated Leukemia (AUL), i.e. no lymphoid or myeloid markers
- Patients with Fanconi Anemia
Who the study is looking for
- Recipient, or recipient's parents, or recipient's legal guardians must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
- Must have histopathologically confirmed diagnosis in one of the followed categories:
- AML
- MDS with intermediate or high-risk disease
- ALL
- Children and adults at any age with significant morbidity, as determined by the primary bone marrow transplant (BMT) doctor (MD), and approved by the principal investigator (PI)
- Able to lie supine in a full body cast for approximately 30 minutes, the anticipated duration of each treatment session; for younger patients deep conscious sedation may be required
- Performance status evaluated by Zubrod or Karnofsky (KPS) Performance Scales in patients \> 16 years or Lanksy Performance Scale in children =\< 16 years must have a score \>= 70%
- Adequate cardiac function: cardiac ejection fraction \> 50% by multi gated acquisition scan (MUGA) scan and/or by echocardiogram
- Adequate pulmonary function: adults (older than 16 years): diffusing capacity of carbon monoxide (DLCO) \> 50%; for young children in whom pulmonary function tests (PFT) are not applicable: assessment by a pediatrician or pulmonary consult
- Adequate renal function as demonstrated by: creatinine clearance or glomerular filtration rate (GFR) \> 60 cc/min (24 hour urine collection)
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =\< 5.0 times the institutional upper limits of normal
- Patients must have less than 15% peripheral blasts
- Pre-treatment tests must have been preformed within 30 days prior to initiation of high-dose chemotherapy
- No other medical and/or psychosocial problems, which in the opinion of the primary physician or principle investigator would place the patient at unacceptable risk from this regimen
Age in the registry: 7 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.