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Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant (ALTERGREF)

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ClinicalTrials.gov Identifier: NCT03250546
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplant Procedure: transplant from a haplo-identical donor Procedure: transplant from a non related donor Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective Phase II Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Arm Intervention/treatment
Experimental: Haplo-identical group Procedure: transplant from a haplo-identical donor
The transplant procedures will be similar in the 2 groups beside the origin of cells

Active Comparator: HLA-9/10 MMUD group Procedure: transplant from a non related donor
The transplant procedures will be similar in the 2 groups beside the origin of cells




Primary Outcome Measures :
  1. Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. 100 day engraftment [ Time Frame: day 100 ]

Other Outcome Measures:
  1. Overall survival [ Time Frame: 2 year ]
  2. Progression Free survival [ Time Frame: 2 year ]
  3. Cumulative incidence of progression [ Time Frame: 2 year ]
  4. Acute GVHD incidence [ Time Frame: day 100 ]
  5. Chronic GVHD incidence [ Time Frame: 2 year ]
  6. Non relapse Mortality (NRM) [ Time Frame: year 2 ]
  7. Stages of Chimerism [ Time Frame: month 1, 2, 3, 6 and 12 ]
    • Complete chimerism: 100% donor cells detected, suggesting complete hematopoietic replacement
    • Mixed chimerism: Host cells are detected in particular cells like lymphocytes. Five to 90% donor cells
    • Split chimerism: One or more lineages are of host and one or more lineages are of donor, like myeloid cells are 100% host and T-cells are 100% donor.

  8. Severe infections [ Time Frame: 2 year ]
  9. Time interval between diagnosis and transplant [ Time Frame: day 100 ]
  10. Adverse events [ Time Frame: day 100 and two years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250546


Locations
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France
Saint Louis hospital Recruiting
Paris, France, 75010
Contact: Nathalie DHEDIN, MD    33+142385127    nathalie.dhedin@aphp.fr   
Principal Investigator: Nathalie Dhedin, MD         
Service Hématologie Clinique Recruiting
Paris, France, 75013
Contact: Stéphanie NGUYEN, MD PhD    33+142162823    stephanie.nguyen-quoc@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03250546    
Other Study ID Numbers: P151001
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No