Second Transplantation for Graft Failure

Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation

Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.

Study Overview

• Status: Unknown
• Conditions: Graft Failure; Stem Cell Transplant Complications
• Intervention / Treatment: Other: second allogeneic stem cell transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YUQIAN SUN; Phone Number: 861088324577; Email: sunyuqian83@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: YUQIAN SUN; Phone Number: 861088324577; Email: sunyuqian83@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• graft failure after first allogeneic stem cell transplantation
• no active infection or GVHD or severe organ dysfunction
• sign written informed consent

Exclusion Criteria:

• active infection, GVHD, organ failure
• expected life < 28 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; second allogeneic stem cell transplantation	Other: second allogeneic stem cell transplantation; Change another donor; conditioning regimen: FLU/CY/anti-CD25 moAb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
engraftment	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRM at 28 day	treatment-related mortality(TRM) was defined as death from any cause other than relapse.	28 days after second transplantation
TRM at 100d	treatment-related mortality(TRM) was defined as death from any cause other than relapse.	day 100 after second transplant
Overall survival at 100d	Overall survival at 100d	day100 after second transplantation

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Publications and helpful links

General Publications

• Sun YQ, Wang Y, Wang FR, Yan CH, Cheng YF, Chen YH, Zhang YY, Han TT, Han W, Suo P, Xu LP, Zhang XH, Liu KY, Huang XJ. Graft Failure in Patients With Hematological Malignancies: A Successful Salvage With a Second Transplantation From a Different Haploidentical Donor. Front Med (Lausanne). 2021 Jun 4;8:604085. doi: 10.3389/fmed.2021.604085. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 30, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2nd tx for GF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No