NCT06512519

Brief Summary

Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress63%
Jul 2024Jun 2027

Study Start

First participant enrolled

July 1, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

July 16, 2024

Last Update Submit

November 5, 2024

Conditions

Graft FailureStem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

  • Engraftment of neutrophils

    Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.

    28 days after second transplantation

Secondary Outcomes (7)

  • Engraftment of Platelet

    100 days after second transplantation

  • TRM at 28 day

    28 days after second transplantation

  • TRM at 100 day

    100 days after second transplantation

  • GVHD

    Participants will be followed for an expected average of 1 year

  • OS

    Participants will be followed for an expected average of 1 year

  • +2 more secondary outcomes

Study Arms (1)

intervention arm

EXPERIMENTAL

second haploidentical stem cell transplantation

Other: second allogeneic stem cell transplantation

Interventions

second allogeneic stem cell transplantationOTHER

1. Change another donor if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)

intervention arm

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.

You may not qualify if:

  • \. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\>2; 5. Expected life time\<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Officials

  • Xiao-Jun Huang, M.D.

    Institute of Hematology, Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-qian Sun, M.D.

CONTACT

+86-10-88324577sunyuqian83@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)