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

ConditionsAcute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAdult Diffuse Large Cell LymphomaAnaplastic Large Cell LymphomaBurkitt LymphomaChronic Myeloid Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaHodgkin LymphomaLymphoblastic LymphomaLymphoplasmacytic LymphomaMantle Cell LymphomaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeProlymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaRefractory Follicular LymphomaRefractory Marginal Zone LymphomaRefractory Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Acute leukemia (AL) that includes acute myeloid leukemia (AML) / acute lymphoblastic leukemia (ALL) / mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study

Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor

Chronic myelomonocytic leukemia (CMML)

Myelodysplastic syndromes (MDS)

Disqualifiers

Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation

Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years

Pregnant or breastfeeding

Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allogeneic Hematopoietic Stem Cell Transplantation

    Procedure/Surgery

    Undergo allogeneic hematopoietic stem cell transplantation

  • Cyclophosphamide

    Drug

    Given IV

  • Cyclosporine

    Drug

    Given IV or PO

  • Filgrastim

    Biological/Vaccine

    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/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm A (high dose treosulfan)Experimental treatment 15 interventions
Group B: Arm B (low dose treosulfan)Experimental treatment 15 interventions

Trial outcomes

Primary outcomes

1

Graft failure/rejection

The analysis for graft failure will be conducted among all patients as well as separately among patients by Arm A versus Arm B.

Time frame
Up to 2 years post-transplant

Secondary outcomes

1

Overall survival

Time frame
At 1 and 2 years post-transplant
2

Progression free survival

Defined as the probability of being alive without sign of disease relapse or progression. Will be summarized using Kaplan-Meier and cumulative incidence estimates, as appropriate.

Time frame
At 1 year post-transplant
3

Non-relapse mortality

Defined as death from any cause without sign of disease progression or relapse. Will be summarized using Kaplan-Meier and cumulative incidence estimates, as appropriate.

Time frame
At day 100 and 1 year post-transplant
4

Relapse

Time frame
At 1 and 2 years post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

medac GmbH

Collaborator

Source ClinicalTrials.gov
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