Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04195633
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Adult Diffuse Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Burkitt Lymphoma
  • Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Chronic Myelomonocytic Leukemia
  • Hodgkin Lymphoma
  • Lymphoblastic Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Mantle Cell Lymphoma
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome
  • Prolymphocytic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Follicular Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic hematopoietic stem cell transplantation
  • Cyclophosphamide — DRUG
    Given IV
  • Cyclosporine — DRUG
    Given IV or PO
  • Filgrastim — BIOLOGICAL
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Mycophenolate Sodium — DRUG
    Given PO
  • Total-Body Irradiation — RADIATION
    Undergo total-body irradiation
  • Treosulfan — DRUG
    Given IV
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Key Dates

Start date
Jan 25, 2021
Status verified
May 2026
Primary completion
Apr 15, 2027
Completion
Mar 12, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (high dose treosulfan)
    Patients receive high dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation on day -1 and allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive cyclophosphamide IV over 1-2 hours on days 3-4. Beginning on day 5, patients receive cyclosporine IV BID or TID over 1-2 hours or PO (after 3 months, in the absence of GVHD, cyclosporine tapering will start by 5-10% per week, until drug withdrawal at 6 months post-transplant). Beginning on day 5, patients also receive mycophenolate sodium PO TID or mycophenolate mofetil IV or PO TID until day 35 (may be continued if active GVHD is present). Beginning on day 5, patients also receive filgrastim until the absolute neutrophil count is \> 1,000/uL for 3 consecutive days. Additionally, patients undergo bone marrow aspiration and biopsy, and echocardiography at baseline and blood sample collection and CT or PET/CT on study.
  • Experimental: Arm B (low dose treosulfan)
    Patients receive low dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation and allogeneic hematopoietic stem cell transplantation, and receive cyclophosphamide, cyclosporine, mycophenolate sodium or mycophenolate mofetil, and filgrastim as in Arm A. Additionally, patients undergo bone marrow aspiration and biopsy, and echocardiography at baseline and blood sample collection and CT or PET/CT on study.

Primary Outcome Measure

Graft failure/rejection [ Time Frame: Up to 2 years post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Phuong Vo, MD
[email protected]
206-667-2749
Phuong Vo, MD (PRINCIPAL_INVESTIGATOR)

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