Haplo SCT vs Haplo-cord SCT for Patients With Hematological Disorders

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03719534
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 67
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Patients who have hematological disorders and will undergo haplo-identical donor stem cell transplantation (haplo SCT) are candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo SCT, while Arm B will receive an co-infusion of an unrelated cord blood unit (haplo-cord SCT) in addition to Arm A. Overall survival, progression-free survival, nonrelapse mortality and cumulative incidence of relapse will be recorded and endpoints.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation; Haplo-identical Donor; Cord Blood; Hematologic Diseases	Procedure: haplo-SCT; Procedure: haplo-cord SCT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Haplo-identical Stem Cell Transplantation Versus Haplo-cord Stem Cell Transplantation for Patients With Hematological Disorders
• Actual Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Haplo-SCT people enrolled in this arm will receive a typical haplo-identical donor SCT	Procedure: haplo-SCT; SCT will be performed with a haplo-identical donor
Experimental: Haplo-cord SCT people enrolled in this arm will receive a co-infusion of cord blood unit in addition to a typical haplo-identical donor SCT	Procedure: haplo-cord SCT; Haplo-identical donor SCT will be performed with co-infusion of unrelated cord blood unit

Outcome Measures

Primary Outcome Measures

1. Overall survival from SCT [3 year post-SCT]

   estimated overall survival at 3 year post-SCT

Secondary Outcome Measures

1. Progression-free survival from SCT [3 year post-SCT]

   estimated progression-free survival at 3 year post-SCT

2. Cumulative incidence of non-relapse mortality from SCT [3 year post-SCT]

   estimated nonrelapse mortality at 3 year post-SCT

3. Cumulative incidence of relapse from SCT [3 year post-SCT]

   estimated cumulative incidence of nonrelapse mortality at 3 year post-SCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with hematological disorders and preparing to perform allogeneic stem cell transplantation;

• Have no available HLA matched donor;

• A haplo-identical donor is available for stem cell collection;

• An unrelated cord blood unit is available with at least 4/6 matched HLA loci;

• ECOG 0-3;

• Could understand the written inform consent.

Exclusion Criteria:

• contraindication of stem cell transplantation;

• uncontrolled active infection;

• sever organ dysfunction (heart, lung, liver, kidney, etc.);

• participating other trials with same purpose

• refuse to sign written inform consent;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT03719534
• Other Study ID Numbers: SZ3703
• First Posted: Oct 25, 2018
• Last Update Posted: Feb 5, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hematologic Diseases

Study Results

No Results Posted as of Feb 5, 2020