Two Step Haplo With Radiation Conditioning
Public ClinicalTrials.gov record NCT05031897. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.
Study identification
- NCT ID
- NCT05031897
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 63 participants
Conditions and interventions
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Adult T-Cell Leukemia/Lymphoma
- Aplastic Anemia
- Chronic Lymphocytic Leukemia
- Chronic Myeloid Leukemia, BCR-ABL1 Positive
- Chronic Myelomonocytic Leukemia
- Essential Thrombocythemia
- Hematopoietic and Lymphatic System Neoplasm
- Hodgkin Lymphoma
- Multiple Myeloma
- Myelodysplastic Syndrome
- Myelofibrosis
- Myeloid Neoplasm
- Non-Hodgkin Lymphoma
- Polycythemia Vera
- Small Lymphocytic Lymphoma
Interventions
- Fludarabine Drug
- Total-Body Irradiation Radiation
- Donor Lymphocyte Infusion Procedure
- Cyclophosphamide Drug
- Tacrolimus Drug
- Mycophenolate Mofetil Drug
- Hematopoietic Cell Transplantation Procedure
- Melphalan Drug
- Bone Marrow Aspiration and Biopsy Procedure
- Diagnostic Imaging Procedure
- Biospecimen Collection Procedure
Drug · Radiation · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 24, 2021
- Primary completion
- Mar 31, 2032
- Completion
- Mar 31, 2032
- Last update posted
- Oct 29, 2025
2021 – 2032
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadephia | Pennsylvania | 19107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05031897, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05031897 live on ClinicalTrials.gov.