NCT03250546

Brief Summary

The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD). It will use a Phase II, multicenter, prospective, randomized clinical trial. By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

5 years

First QC Date

July 31, 2017

Last Update Submit

February 18, 2019

Conditions

Hematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

  • Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD

    2 year

Secondary Outcomes (1)

  • 100 day engraftment

    day 100

Other Outcomes (10)

  • Overall survival

    2 year

  • Progression Free survival

    2 year

  • Cumulative incidence of progression

    2 year

  • +7 more other outcomes

Study Arms (2)

Haplo-identical group

EXPERIMENTAL
Procedure: transplant from a haplo-identical donor

HLA-9/10 MMUD group

ACTIVE COMPARATOR
Procedure: transplant from a non related donor

Interventions

transplant from a haplo-identical donorPROCEDURE

The transplant procedures will be similar in the 2 groups beside the origin of cells

Haplo-identical group
transplant from a non related donorPROCEDURE

The transplant procedures will be similar in the 2 groups beside the origin of cells

HLA-9/10 MMUD group

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • With a hematological malignancy requiring a HSCT and at least in partial response ie a) Acute Leukemia in complete remission, b) Myelodysplastic syndromes with less than 20% marrow, c) Myeloproliferative syndromes with less than 20% bone marrow blasts, d) Non Hodgkin Lymphoma (NHL), Hodgkin's disease, chronic lymphocytic leukemia at least in partial response, e) Myeloma at least in partial response.
  • Without HLA matched related or unrelated donor
  • Identification of a possible HLA-9/10 MMUD and a possible haplo-identical donor.
  • Having read and understood the information letter and signed the informed consent
  • With health insurance coverage

You may not qualify if:

  • Organic or psychiatric disease, non related to the hematological malignancy, contraindicating the transplant.
  • Performance Scale by the Eastern Cooperative Oncology Group (ECOG)\> 2
  • Severe uncontrolled infection
  • Cardiac contraindication of post-transplant Cy (coronary insufficiency, ejection ventricular fraction \<50%)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) \> 2.5 N, creatinine \> 150 mmol/L (except if related to malignancy)
  • Previous active cancer in the last two years, except basal cell skin cancer and in situ carcinoma of the cervix
  • Childbearing age woman refusing contraception
  • Patients who did not accept the follow-up planned by the protocol
  • Positive serology for HIV or Human T-Lymphotropic Virus (HTLV)-1, 2, or active viral infection by the Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
  • Pregnant woman (positive β-HCG) or during lactation
  • Adult patient on guardianship, or safeguard justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis hospital

Paris, 75010, France

RECRUITING

Service Hématologie Clinique

Paris, 75013, France

RECRUITING

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized prospective Phase II Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 15, 2017

Study Start

November 20, 2017

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

FR(2)