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Two Step Haplo With Radiation Conditioning

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Suspended to Recruitingv10 Show 4 more changesShow less
    • Primary endpoint revised
    • Site details revised
    • Study title shortened, about 11 words
    • Study arms: 2 to 3
  2. Site details revisedv9
  3. Trial status: Recruiting to Suspended Sponsor's reason: Study was suspended by the DSMC due to a protocol deviation.
    • Site details revised
    v8
  4. Primary and study completion dates: Apr 2025 to Apr 2032v7
  5. Primary and study completion dates: Oct 1, 2024 to Apr 2025v6 Show 4 more changesShow less
    • Enrollment target: 67 to 63
    • Interventions: Cyclophosphamide (Drug), Donor Lymphocyte Infusion (Procedure), Fludarabine (Drug), Hematopoietic Cell Transplantation (Procedure)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy (Procedure), Cyclophosphamide (Drug), Diagnostic Imaging (Procedure)…
    • Eligibility criteria shortened, about 7 words
    • Study description expanded, about 26 words
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Site contact updatedv4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 13, 2021 to Oct 25, 2021
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Thomas Jefferson University
113 trials monitored
See 5 trials at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
Acute Myeloid Leukemia (AML)
1,269 trials monitored
See 74 trials at risk
and 8 more diseases
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.
Trial Details
NCT Number NCT05031897
Lead Sponsor Thomas Jefferson University
Conditions
(from sponsor)		 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 +9 more
Related terms Anemia, Aplastic, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Lymphoma, Non-Hodgkin, Multiple Myeloma, Myelodysplastic Syndromes, Polycythemia Vera, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Primary Myelofibrosis, Thrombocythemia, Essential
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov