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Acute LeukemiaNCT05335226

Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

A study testing Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation and haploidentical hematopoietic stem cell transplantation in people with Acute Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Leukemia
What is being tested?
Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation and haploidentical hematopoietic stem cell transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteChina
Study dates
6 Jun 2022to 1 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 16-65 years inclusive.
  • Diagnosed as acute leukemia, planning to receive haplo-HSCT
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Presence of an available haploidentical donor
  • Signing written informed consent and agreeing with taking designated umbilical cord blood

Who cannot join

  • Uncontrolled infections less than 4 weeks prior to enrollment
  • Secondary malignancy
  • Psychiatric illness that would limit compliance with study requirements
  • Impairment of heart, hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
  • Allergic to blood products
  • Other causes which are not suitable for the trial in investigator's consideration

Trial locations and contacts

1 site in 1 country.

Aiming Pang contact

+86-13820398091

pangaiming@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300041

    Erlie Jiang, +86-15122538106, jiangerlie@ihcmas.ac.cn

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.

Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. However, the engraftment failure and incidence of graft-versus-host disease(GVHD) limit the prognosis of patients who receive the haplo-HSCT. It is believed that Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of GVHD, there is still no consensus about the efficacy and safety of this kind of therapy. This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

Read the detailed description

This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. Investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-HSCT group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. Then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.

Conditions
Acute Leukemia
Being tested
Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation, haploidentical hematopoietic stem cell transplantation
Keywords
Acute Leukemia, haplo-hematopoietic stem cell transplantation (haplo-HSCT), umbilical cord blood stem cell transplantation (UCBT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined haploidentical and umbilical cord blood allogeneic stem cell transplantationProcedure or surgery

    Patients will receive umbilical cord blood allogeneic stem cell transplantation at the same day as the haploidentical stem cell transplantation. (HLA 6-10/10, TNC≥1-3×10-7/Kg)

  • haploidentical hematopoietic stem cell transplantationProcedure or surgery

    Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)

Study groups in NCT05335226
Study groupRoleWhat they receive
Haplo-HSCT groupExperimental58 patients will be involved in this group
Receives: Procedure: haploidentical hematopoietic stem cell transplantation
Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation groupExperimental58 patients will be involved in this group
Receives: Procedure: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up

    Measured: 12 months

  2. Disease free survival

    Defined as the time starting at the day of transplantation, terminating at the day when the sign of AL is found or the end of follow-up

    Measured: 12 months

Secondary outcomes (7)

  1. Cumulative relapse incidence

    Defined as the cumulative incidence of relapse after the day of transplantation

    Measured: 12 months

  2. Cumulative incidence of engraftment

    Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10^9/L or more for three consecutive days , while platelet recovery difined as 20×10^9/L or more for seven consecutive days without transfusion

    Measured: 12 months

  3. cumulative incidence of acute graft-versus-host disease(GVHD)

    Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria

    Measured: 12 months

  4. cumulative incidence of chronic GVHD at one year

    chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)

    Measured: 12 months

  5. Cumulative Incidence of Infectious Complications

    Defined as cumulative incidence of viral, fungal and bacterial infections

    Measured: 12 months

  6. Cumulative Incidence of hemorrhagic cystitis

    Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation

    Measured: 12 months

  7. Cumulative Incidence of lymphoproliferative disease

    Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start6 Jun 2022
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05335226
Sponsor's protocol ID
20220410
Status last verified
Aug 2022
First submitted
12 Apr 2022
Last updated
11 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation and haploidentical hematopoietic stem cell transplantation in people with Acute Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aiming Pang (+86-13820398091, pangaiming@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05335226.

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 11 Aug 2022.

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