Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies

NCT03771222 | Unknown Phase 2

• 1 other identifier: pDLI2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as TP53, TET2 and DNMT3a. Donor lymphocyte infusion (DLI) is an option to reduce relapse after allo-PBSCT for very high-risk disease without effective targeted therapy. In this study, the investigators aimed to compare the safety and efficacy of prophylactic DLI with G-CSF-primed peripheral blood progenitors for prevention of relapse after allo-PBSCT in patients with very high-risk leukemia/lymphoma.

Conditions

Donor Lymphocyte Infusion; Peripheral Blood Stem Cell Transplantation; Relapse; Graft-versus-host Disease; Decitabine

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of relapse at 1 year after randomization

  Relapse was defined as hematologic recurrence of malignancies after transplantation. Cumulative incidence of relapse was analyzed in a competing risk framework using Gray's method.

  1 year

• Cumulative incidence of non-relapse mortality (NRM) at 1 year after randomization

  NRM was defined as death from any cause without relapse. Cumulative incidence of NRM was analyzed in a competing risk framework using Gray's method.

  1 year

Secondary Outcomes (3)

• Relapse-free survival (RFS) at 1 year after randomization

  1 year

• Cumulative incidence of acute GVHD at 100 days after randomization

  100 days

• Cumulative incidence of chronic GVHD at 1 year after randomization

  1 year

Study Arms (2)

Prophylactic DLI

EXPERIMENTAL

The scheduled time of the first prophylactic DLI was +30 \~ +60 days after transplantation for HLA-matched sibling donors (MSD)-PBSCT recipients and +60 \~ +90 days after transplantation for HLA-haploidentical sibling donors (HID)-PBSCT recipients.

Biological: Prophylactic DLI

No prophylactic DLI

NO INTERVENTION

Interventions

Prophylactic DLI BIOLOGICAL

The G-CSF-mobilized PBSCs from cryopreserved cells of the graft were infused to the recipient at a dose of 2X10\^7 CD3+ cells/kg recipient body weight. Decitabine (10 mg/m2, days 1 to 5) followed by prophylactic DLI would be given to those patients carrying TET2, DNMT3a or TP53 gene mutations.

Also known as: Decitabine (trade name Dacogen)

Prophylactic DLI

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• disease in the non-remission (NR) state prior to transplantation, including primary induction failure, relapse untreated or refractory to reinduction chemotherapy.
• achieving CR1 with ≥3 cycles of induction of chemotherapy.
• carrying TP53, DNMT3a, TET2 or FLT3-ITD gene mutation.

You may not qualify if:

• early relapse, either molecular relapse or hematological relapse.
• primary or secondary graft failure.
• concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure…).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Recurrence; Graft vs Host Disease

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)