Haploidentical and Mismatched Unrelated Donors Hematopoie... | NCT03250546

Studies
Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

NCT03250546

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Feb 19, 2019Actual

Enrollment

184Estimated

Phase

Phase 2

Conditions

Hematopoietic Stem Cell Transplant

Interventions

transplant from a haplo-identical donor
transplant from a non related donor

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2017Actual

Primary Completion Date

Nov 30, 2022Estimated

Completion Date

Nov 30, 2022Estimated

First Submitted Date

Jul 31, 2017

First Submission Date that Met QC Criteria

Aug 14, 2017

First Posted Date

Aug 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2019

Last Update Posted Date

Feb 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
transplant from a haplo-identical donor	Procedure	The transplant procedures will be similar in the 2 groups beside the origin of cells	Haplo-identical group

Measure	Description	Time Frame
Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD		2 year

Measure	Description	Time Frame
100 day engraftment		day 100

Measure	Description	Time Frame
Overall survival		2 year
Progression Free survival		2 year
Cumulative incidence of progression

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided