Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study) (COmPACt)
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ClinicalTrials.gov Identifier: NCT03802773 |
Recruitment Status : Unknown
Verified April 2020 by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Recruitment status was: Recruiting
First Posted : January 14, 2019
Last Update Posted : May 5, 2020
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Condition or disease | Intervention/treatment |
---|---|
Cord Blood Transplantation Hematological Malignancies | Procedure: CB transplantation |
Study Type : | Observational |
Estimated Enrollment : | 10 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study) |
Actual Study Start Date : | March 14, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | March 30, 2021 |

- Procedure: CB transplantation
Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.Other Name: Myeloablative conditioning and post-transplant cyclophosphamide
- hematopoietic reconstitution [ Time Frame: first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L ]number of days for neutrophil (> 0.5x10^9/L) and platelet (> 20x10^9/L) engraftment
- immune reconstitution [ Time Frame: day 100 from transplant ]number of CD4+cells at day 100

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age: ≥ 18 ≤ 75 years old
- CB unit transplantation (TNC> 2,0 x10^7/kg and > 4/6 loci HLA matched)
- Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine
- GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF
- Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.
Exclusion Criteria:
- Positive serologic markers for human immunodeficiency virus (HIV)
- Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection

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): NCT03802773
Contact: Andrea Bacigalupo, Prof. | 0630154180 | andrea.bacigalupo@unicatt.it | |
Contact: Luciana Teofili, MD | 0630154373 | luciana.teofili@unicatt.it |
Italy | |
Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting |
Roma, RM, Italy, 00168 | |
Contact: Andrea Bacigalupo, Prof. 0630154180 andrea.bacigalupo@unicatt.it |
Principal Investigator: | Patrizia Chiusolo, MD | Fondazione Policlinico Universitario A. Gemelli, IRCCS |
Responsible Party: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
ClinicalTrials.gov Identifier: | NCT03802773 |
Other Study ID Numbers: |
11/2018 |
First Posted: | January 14, 2019 Key Record Dates |
Last Update Posted: | May 5, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Cyclophosphamide Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |