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This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.
Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion.
A major drawback of Umbilical Cord Blood (UCB) is the low stem cell dose available for transplantation, compared to mobilized peripheral blood (PB) or bone marrow. This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery, as well as other transplant outcomes.
The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation.
NiCord® is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of UCB. NiCord® utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of Hematopoietic Progenitor Cells (HPC) expanded in ex vivo cultures. The chief aim of the study is to compare the safety and efficacy of NiCord® single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NiCord® (omidubicel) | Experimental | NiCord® is a cryopreserved stem/progenitor cell based product comprised of:
Both fractions, i.e. NiCord® CF and NiCord® NF, will be kept frozen until they are thawed and infused on the day of transplantation. |
|
| Unmanipulated CBU(s) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NiCord® (omidubicel) | Drug |
| ||
| Cord Blood Unit |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Engraftment | The time to engraftment of neutrophils >500/μl was defined as per Center for International Blood and Marrow Transplant Research (CIBMTR) standards, requiring donor chimerism for neutrophil engraftment. | post-transplant up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation | First Bacterial Infection Grades 2-3 or Invasive Fungal Infection by 100 Days following Transplantation for the Intent to Treat Population | 100 days post-transplant |
| Days Alive and Out of Hospital in the First 100 Days Post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| LTF Chimerism | Kaplan Meier probability of donor chimerism <95% | By 5 years post-transplant |
| LTF Overall Survival | Kaplan Meier probability of overall survival |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Horwitz, MD | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37703995 | Derived | Majhail NS, Miller B, Dean R, Manghani R, Shin H, Sivaraman S, Maziarz RT. Hospitalization and Healthcare Resource Utilization of Omidubicel-Onlv versus Umbilical Cord Blood Transplantation for Hematologic Malignancies: Secondary Analysis from a Pivotal Phase 3 Clinical Trial. Transplant Cell Ther. 2023 Dec;29(12):749.e1-749.e5. doi: 10.1016/j.jtct.2023.09.004. Epub 2023 Sep 12. | |
| 37120136 |
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125 patients were screened, met inclusion criteria and were randomized to treatment from 33 transplant centers worldwide. First patient was consented on 20th December 2016 and the last patient consented on 27th December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | NiCord® (Omidubicel) | NiCord® is a cryopreserved stem/progenitor cell based product comprised of:
Both fractions, i.e. NiCord® CF and NiCord® NF, will be kept frozen until they are thawed and infused on the day of transplantation. NiCord® (omidubicel) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2019 | Mar 28, 2022 |
Not provided
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Not provided
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Not provided
Cord blood unit |
|
Days alive and out of hospital in the first 100 Days post-transplantation for the Intent to Treat Population |
| 100 days post-transplantation |
| Number of Participants With Platelet Engraftment by 42 Days Post-transplantation | Platelet engraftment defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count > 20 × 10^9/L with no platelet transfusions during the preceding seven days (counting day of engraftment as one of the preceding seven days) for the Intent to Treat Population | 42 days post-transplantation |
| By 5 years post-transplant |
| LTF Disease Progression/Relapse | Number of patients with relapse during the long-term follow-up period | By 5 years post-transplant |
| LTF Chronic GvHD | Cumulative Incidence of Chronic GvHD | By 5 years post-transplant |
| Los Angeles |
| California |
| 91010 |
| United States |
| Stanford University Cancer Institute | Palo Alto | California | United States |
| UC San Diego Moores Cancer Center | San Diego | California | 92093 | United States |
| Children's Hospital Colorado | Denver | Colorado | 80045 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Loyola University, Cardinal Bernardin Cancer Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| The University of Maryland Medicine Center | Baltimore | Maryland | 21201 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Henry Ford Medical Center | Detroit | Michigan | United States |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Children's | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| West Cancer Clinic | Germantown | Tennessee | 38138 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA | Rio de Janeiro | Rio de Janeiro | 20230-130 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics | São Paulo | São Paulo | 05403-010 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | 05403-010 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | São Paulo | São Paulo | 14048-900 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | Brazil |
| Robert Debré | Paris | 75019 | France |
| Rambam | Haifa | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | Israel |
| Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital | Tel Litwinsky | Israel |
| Careggi University Hospital | Florence | 50134 | Italy |
| Ospedale Pediatrico Bambino Gesù | Rome | 00165 | Italy |
| University Medical Center Utrecht | Utrecht | 3503 AB | Netherlands |
| Prinses Maxima Centrum voor Kinderoncologie B.V. | Utrecht | 3584 CS | Netherlands |
| Instituto Português de Oncologia de Lisboa Francisco Gentil | Lisbon | 1099-023 | Portugal |
| National University Cancer Institute | Singapore | 119074 | Singapore |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Hospital Universitari Vall d'Hebron pediatrics | Barcelona | 08035 | Spain |
| University Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| ICO Bellvitge | Barcelona | 08908 | Spain |
| Sant Joan de Deu | Barcelona | 08950 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitario Virgen del RocÃo | Seville | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| Hospital Universitario y Politécnico La Fe (pediatric) | Valencia | Spain |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| St James Hospital | Leeds | LS9 7TF | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| Derived |
| Szabolcs P, Mazor RD, Yackoubov D, Levy S, Stiff P, Rezvani A, Hanna R, Wagner J, Keating A, Lindemans CA, Karras N, McGuirk J, Hamerschlak N, Lopez-Torija I, Sanz G, Valcarcel D, Horwitz ME. Immune Reconstitution Profiling Suggests Antiviral Protection after Transplantation with Omidubicel: A Phase 3 Substudy. Transplant Cell Ther. 2023 Aug;29(8):517.e1-517.e12. doi: 10.1016/j.jtct.2023.04.018. Epub 2023 Apr 28. |
| 34157093 | Derived | Horwitz ME, Stiff PJ, Cutler C, Brunstein C, Hanna R, Maziarz RT, Rezvani AR, Karris NA, McGuirk J, Valcarcel D, Schiller GJ, Lindemans CA, Hwang WYK, Koh LP, Keating A, Khaled Y, Hamerschlak N, Frankfurt O, Peled T, Segalovich I, Blackwell B, Wease S, Freedman LS, Galamidi-Cohen E, Sanz G. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440. doi: 10.1182/blood.2021011719. |
| 33811823 | Derived | Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available. |
| FG001 | Unmanipulated CBU(s) | Unmanipulated cord blood unit(s) |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NiCord® (Omidubicel) | NiCord® is a cryopreserved stem/progenitor cell based product comprised of:
Both fractions, i.e. NiCord® CF and NiCord® NF, will be kept frozen until they are thawed and infused on the day of transplantation. NiCord® (omidubicel) |
| BG001 | Unmanipulated CBU(s) | Unmanipulated cord blood unit(s) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Neutrophil Engraftment | The time to engraftment of neutrophils >500/μl was defined as per Center for International Blood and Marrow Transplant Research (CIBMTR) standards, requiring donor chimerism for neutrophil engraftment. | intent to treat | Posted | Median | 95% Confidence Interval | days | post-transplant up to 42 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation | First Bacterial Infection Grades 2-3 or Invasive Fungal Infection by 100 Days following Transplantation for the Intent to Treat Population | Intent to Treat Population | Posted | Count of Participants | Participants | 100 days post-transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Days Alive and Out of Hospital in the First 100 Days Post-transplantation | Days alive and out of hospital in the first 100 Days post-transplantation for the Intent to Treat Population | Intent to Treat Population | Posted | Median | Full Range | Days | 100 days post-transplantation |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Platelet Engraftment by 42 Days Post-transplantation | Platelet engraftment defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count > 20 × 10^9/L with no platelet transfusions during the preceding seven days (counting day of engraftment as one of the preceding seven days) for the Intent to Treat Population | Intent to Treat Population | Posted | Count of Participants | Participants | 42 days post-transplantation |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | LTF Chimerism | Kaplan Meier probability of donor chimerism <95% | Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study | Posted | Number | Kaplan Meier probability | By 5 years post-transplant |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | LTF Overall Survival | Kaplan Meier probability of overall survival | Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study | Posted | Number | KM probability | By 5 years post-transplant |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | LTF Disease Progression/Relapse | Number of patients with relapse during the long-term follow-up period | Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study | Posted | Number | Patients with relapse | By 5 years post-transplant |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | LTF Chronic GvHD | Cumulative Incidence of Chronic GvHD | Patients who were transplanted, alive at Year 1 post-transplant (end of main study) and provided consent to participate in the optional long-term follow-up sub-study | Posted | Number | Proportion | By 5 years post-transplant |
|
|
Up to 5 Years post-transplant for All-cause mortality Up to 1 year post-transplant for all other safety events reported
Safety population (N=108). Serious Adverse Events (SAEs) & Adverse Events (AEs) relate to safety population (SP) (N=108).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omidubicel | omidubicel is a cryopreserved stem/progenitor cell based product comprised of:
| 19 | 52 | 47 | 52 | 52 | 52 |
| EG001 | Unmanipulated CBU(s) | Unmanipulated cord blood unit(s) | 24 | 56 | 51 | 56 | 56 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombotic microangiopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Veno-occlusive liver disease | Hepatobiliary disorders | Systematic Assessment |
| ||
| Graft-versus-host disease | Immune system disorders | Systematic Assessment |
| ||
| Femoral Neck Failure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transplant Failure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| CNS events | Nervous system disorders | Systematic Assessment |
| ||
| Renal disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| GI Disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infections | Infections and infestations | Systematic Assessment |
| ||
| Metabolic disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hematologic malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombotic microangiopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Toxicity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Mucosal Inflammation | General disorders | Systematic Assessment |
| ||
| Edema | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| veno-occlusive liver disease | Hepatobiliary disorders | Systematic Assessment |
| ||
| acute graft-versus-host-disease | Immune system disorders | Systematic Assessment |
| ||
| Chronic Graft-versus-host-disease | Immune system disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| CMV Infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes infection | Infections and infestations | Systematic Assessment |
| ||
| Human Herpesvirus 6 infection | Infections and infestations | Systematic Assessment |
| ||
| Lower respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transplant Failure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Disease recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Cystitis hemorrhagic | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Vascular access complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The analyses of the long term follow-up sub-study were descriptive only and the study was not powered to detect statistical differences between the treatment groups.
Sponsor can review/comment at least 30 days before publication submission. At Sponsor request, site will withhold publication another 60 days to allow for patent application or other measures Sponsor deems appropriate to establish & preserve its proprietary rights. Results publication made as part of those obtained by all sites performing protocol. Site free to publish based on its study results after publication of multi-center results or one year after completion/termination of site study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Operations | Gamida Cell | +972-073-2064774 | aurelie@gamida-cell.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2020 | Jun 7, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Singapore |
|
| United States |
|
| Brazil |
|
| United Kingdom |
|
| Israel |
|
| Spain |
|
|
|
| Participants |
|
|
|
|
|
|