NCT04167683

Brief Summary

PURPOSE: To investigate the effect of the disease and HSCT on muscle dysfunction and to investigate the prognostic role of muscle dysfunction at critical decision points in patients with hematological diseases referred to hematopoietic stem cell transplant (HSCT). HSCT: Patients diagnosed with malignant hematological diseases who are referred to myeloablative HSCT, to a myeloablative "reduced toxicity conditioning" regime with Fludarabine and Treosulfane (FluTreo) or to non-myeloablative HSCT.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Oct 2023Nov 2026

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3.9 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

November 15, 2019

Last Update Submit

December 1, 2025

Conditions

Chronic Lymphocytic LeukemiaHematologic DiseasesChronic Myeloid LeukemiaAcute Myeloid LeukemiaAcute Lymphoid LeukemiaMyelodysplastic SyndromesNon Hodgkin LymphomaStem Cell Transplant Complications

Keywords

Muscle massMuscle strengthComplicationsPatient reported outcomesPROPhysical functionhematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Cohort 1 and Cohort 2 Medical treatment complications

    Incidens rate of medical complications (mortality, re-hospitalization, infections, all cause disease relapse, chronic GVHD, return to work)

    From baseline to 1 year follow-up

Secondary Outcomes (19)

  • Hospitalization duration

    From baseline to 1 year follow-up

  • Disease free survival

    From baseline to 1 year follow-up

  • Overall survival

    From baseline to 1 year follow-up

  • Change in whole body lean mass

    From baseline to 1 year follow-up

  • Change in appendicular lean mass

    From baseline to 1 year follow-up

  • +14 more secondary outcomes

Study Arms (2)

Cohort 1 - Patients referred to myeloablative HSCT

These patients will undergo 5 assessments: a baseline-assessment 3-4 week prior to conditioning treatment, at discharge (in-patients) or at day +28 after stem cell infusion (out-patients) and follow-up assessments at 3 months, 6 months and 12 months.

Other: No intervention

Cohort 2 - Patients referred to non myeloablative HSCT

These patients will undergo 5 assessments: a baseline-assessment 3-4 week prior to conditioning treatment, at discharge (in-patients) or at day +28 after stem cell infusion (out-patients) and follow-up assessments at 3 months, 6 months and 12 months.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Cohort 1 - Patients referred to myeloablative HSCTCohort 2 - Patients referred to non myeloablative HSCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant hematological diseases referred to myeloablative HSCT, myeloablative RTC-HSCT or non-myeloablative HSCT.

You may qualify if:

  • Patients diagnosed with acute myelogenous leukaemia (AML), acute lymphatic leukaemia (ALL), chronic myelomonocytic leukaemia (CMML), myelodysplastic syndrome (MDS), chronic lymphatic leukaemia (CLL), malignant lymphomas or multiple myeloma (MM) referred to myeloablative HSCT, myeloablative RTC-HSCT or non-myeloablative HSCT at the Department of Haematology, Rigshospitalet, Blegdamsvej.

You may not qualify if:

  • age \<18; pregnancy; physical or mental disabilities precluding test of muscle function; inability to read and understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Hematologic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphomaLeukemia, B-Cell

Study Officials

  • Jan Christensen, post doc

    Department of Occupational- and Physiotherapy, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post doc

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

October 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Not provided

Locations

DK(1)