Bone Marrow Transplant ComplicationsNCT07823946
Assesment of Upper Egypt Experience in Autologous Bone Marrow Transplantation of Patients With Hematological Malignancies: A Cohor Study
An observational study of Bone Marrow Transplant Complications, run by Assiut University.
Trial summary
Autologous hematopoietic stem cell transplantation (ASCT) is an important treatment for eligible patients with hematological malignancies, particularly multiple myeloma and relapsed lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone Marrow Transplant Complications
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All consecutive adult patients with hematological malignancies who underwent autologous hematopoietic stem cell transplantation at the Bone Marrow Transplantation Unit, Assiut University Hospitals, during the study period and fulfilled the eligibility criteria.
Who may be able to join
- Adult patients (≥18 years) with a confirmed diagnosis of a hematological malignancy.
- Patients undergoing their autologous hematopoietic stem cell transplantation (ASCT).
- willingness to participate in the study
Who cannot join
- Patients undergoing allogeneic hematopoietic stem cell transplantation.
- Patients with uncontrolled active infection or severe organ dysfunction that contraindicates transplantation.
- Patients with incomplete clinical data or who withdraw consent during the study period.
About this study
Autologous hematopoietic stem cell transplantation (ASCT) is an important treatment for eligible patients with hematological malignancies, particularly multiple myeloma and relapsed lymphoma. Although advances in transplantation have improved outcomes, complications such as infections, febrile neutropenia, mucositis, delayed engraftment, organ toxicity, and relapse remain significant. This study aims to evaluate clinical outcomes and patient satisfaction after ASCT and identify factors associated with favorable or unfavorable transplant outcomes.
Read the detailed description
Hematological malignancies are a heterogeneous group of neoplastic disorders arising from the bone marrow and lymphoid tissues, including multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, and selected leukemias. Despite substantial advances in chemotherapy, targeted therapies, and immunotherapy, relapse remains a major cause of treatment failure and disease-related mortality. Autologous hematopoietic stem cell transplantation (ASCT) has become an integral component of treatment for eligible patients by allowing the administration of high-dose chemotherapy followed by reinfusion of the patient's own hematopoietic stem cells to restore bone marrow function, thereby improving disease control and survival outcomes.
ASCT is considered the standard consolidation therapy for transplant-eligible patients with multiple myeloma and an effective salvage treatment for relapsed or refractory Hodgkin lymphoma and selected aggressive non-Hodgkin lymphomas. Advances in stem cell mobilization, cryopreservation techniques, conditioning regimens, antimicrobial prophylaxis, and supportive care have significantly improved engraftment rates while reducing transplant-related morbidity and mortality. However, complications such as febrile neutropenia, severe infections, mucositis, delayed hematopoietic recovery, organ toxicity, and disease relapse continue to adversely affect patient outcomes and quality of life.
Assessment of transplantation outcomes is essential to evaluate the effectiveness and safety of ASCT in routine clinical practice. Several factors, including patient age, disease status at transplantation, performance status, conditioning regimen, CD34⁺ cell dose, and post-transplant complications, may influence survival and treatment success. Therefore, this study aims to assess the clinical outcomes of ASCT and patient satisfaction among patients with hematological malignancies, as well as to identify factors associated with favorable and unfavorable transplant outcomes, thereby contributing to improved patient selection and optimization of transplant strategies.
- Conditions
- Bone Marrow Transplant Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow transplant patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Clinical outcome of autologous hematopoietic stem cell transplantation, including overall survival (OS) and Progression-Free Survival (PFS).
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Askary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823946
- Sponsor's protocol ID
- Autologous B.M. transplantatio
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Upper Egypt Experience in Autologous Bone Marrow Transplantation of Patients With Hematological Malignancies: A Cohor Study
- ClinicalTrials.gov ID
- NCT07823946
- Acronym / sponsor ID
- Autologous B.M. transplantatio
- Conditions
- Bone Marrow Transplant Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous hematopoietic stem cell transplantation (ASCT) is an important treatment for eligible patients with hematological malignancies, particularly multiple myeloma and relapsed lymphoma. Although advances in transplantation have improved outcomes, complications such as infections, febrile neutropenia, mucositis, delayed engraftment, organ toxicity, and relapse remain significant. This study aims to evaluate clinical outcomes and patient satisfaction after ASCT and identify factors associated with favorable or unfavorable transplant outcomes.
Detailed description
Hematological malignancies are a heterogeneous group of neoplastic disorders arising from the bone marrow and lymphoid tissues, including multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, and selected leukemias. Despite substantial advances in chemotherapy, targeted therapies, and immunotherapy, relapse remains a major cause of treatment failure and disease-related mortality. Autologous hematopoietic stem cell transplantation (ASCT) has become an integral component of treatment for eligible patients by allowing the administration of high-dose chemotherapy followed by reinfusion of the patient's own hematopoietic stem cells to restore bone marrow function, thereby improving disease control and survival outcomes.
ASCT is considered the standard consolidation therapy for transplant-eligible patients with multiple myeloma and an effective salvage treatment for relapsed or refractory Hodgkin lymphoma and selected aggressive non-Hodgkin lymphomas. Advances in stem cell mobilization, cryopreservation techniques, conditioning regimens, antimicrobial prophylaxis, and supportive care have significantly improved engraftment rates while reducing transplant-related morbidity and mortality. However, complications such as febrile neutropenia, severe infections, mucositis, delayed hematopoietic recovery, organ toxicity, and disease relapse continue to adversely affect patient outcomes and quality of life.
Assessment of transplantation outcomes is essential to evaluate the effectiveness and safety of ASCT in routine clinical practice. Several factors, including patient age, disease status at transplantation, performance status, conditioning regimen, CD34⁺ cell dose, and post-transplant complications, may influence survival and treatment success. Therefore, this study aims to assess the clinical outcomes of ASCT and patient satisfaction among patients with hematological malignancies, as well as to identify factors associated with favorable and unfavorable transplant outcomes, thereby contributing to improved patient selection and optimization of transplant strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow transplant patients | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients with hematological malignancies who underwent autologous hematopoietic stem cell transplantation at the Bone Marrow Transplantation Unit, Assiut University Hospitals, during the study period and fulfilled the eligibility criteria.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) with a confirmed diagnosis of a hematological malignancy.
- Patients undergoing their autologous hematopoietic stem cell transplantation (ASCT).
- willingness to participate in the study
Key exclusion criteria (3 listed)
- Patients undergoing allogeneic hematopoietic stem cell transplantation.
- Patients with uncontrolled active infection or severe organ dysfunction that contraindicates transplantation.
- Patients with incomplete clinical data or who withdraw consent during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: through study completion, an average of 2 year
Clinical outcome of autologous hematopoietic stem cell transplantation, including overall survival (OS) and Progression-Free Survival (PFS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Transplant Complications, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.