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Slow accrual and change in direction of cord blood program
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| Name | Class |
|---|---|
| New York Blood Center | OTHER |
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The purpose of this study is to determine the overall safety of adoptive immunotherapy when given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells from a donor to help fight cancer. The donor cells will be either from the umbilical cord blood (UCB) of a newborn baby or they will be cells collected from a relative (haplo-identical cells).
The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or haplo-identical stem cells - will be analyzed separately.
Preliminary data from other centers has suggested that adoptive immunotherapy with cells from a relative is an effective approach that may improve remission rates and survival in AML and MDS, because they exert anti-cancer effects of their own (so called graft vs leukemia effects) and possibly because they hasten recovery of cell counts from chemotherapy. The Investigators are interested in confirming these data, but also in testing umbilical cord blood cells for the same purpose. Preliminary data indicate that umbilical cord blood cells may have more powerful graft vs leukemia effects and cause fewer side-effects.
This is a phase 2 trial to evaluate the safety of adoptive immunotherapy with Non-Inherited Maternal Antigen (NIMA) compatible, Inherited Paternal Antigen (IPA) targeted CBU or with haplo-identical stem cells after conventional induction therapy for very high risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
The study has 2 cohorts - patients in cohort 1 will receive CBU cells as adoptive immunotherapy. Patients in cohort 2 will receive haplo-identical cells. Both cohorts will be evaluated separately and no formal statistical comparison between cohorts will be performed.
There will be approximately 20 patients in each cohort, and a 95% confidence interval for the proportion of patients experiencing grade III-IV GVHD complications or unexplained prolonged myelosuppression complications in each cohort can be constructed to be within +/- 13.1% of the observed complication proportions. This calculation assumes an expected prevalence of each of these complication proportions of no greater than 10%.
After 10 patients are enrolled in each group, the incidence of the above-defined life-threatening complications will be assessed. If more than one patient out of 10 enrolled patients (i.e., greater than 10%) in a cohort experiences either of these complications, the cohort will be stopped for safety.
All potential recipients will have complete HLA typing and determination of HLA antibodies. An appropriate umbilical cord blood unit (CBU) will be identified or in the absence of an appropriate CBU, a haplo-identical donor will be identified.
Treatment will be as per the treating physician's choice..
The umbilical cord graft or haplo-graft will be administered between 24 - 72 hours after the completion of the chemotherapy regimen.
The Graft Selection Algorithm is as follows:
Within 42 days of transplant, the recipient's pre-treatment evaluation includes: medical history and physical examinations, Eastern Cooperative Group Oncology Group (ECOG) score, complete blood count (CBC), HLA antibodies, and cytomegalovirus (CMV) antibody testing.
Patients will continue with the therapy specified in this protocol until one of the following occurs:
After removal from protocol therapy, patients will continue to be followed for survival and disease status. Samples for correlative studies will continue to be collected every two months until one year after cell infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cord Blood Unit | Other | The CBU unit must supply a minimum of 0.5 x 10^7/kg and a maximum of 2.5 x 10^7/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will have also undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. CBU grafts in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x 10^7 nucleated blood cells/kg. |
|
| Haploidentical | Other | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haplo-identical cells (donor) | Biological | Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Cellular Immunotherapy as Measured by the Number of Participants Who Developed of Cytokine Release Syndrome (CRS) or Graft-versus-host Disease (GVHD) After Adoptive Immunotherapy | Evaluate the safety of adoptive immunotherapy with Non-Inherited Maternal Antigen (NIMA) compatible, Inherited Paternal Antigen (IPA) targeted CBU or with haplo-identical stem cells after conventional induction therapy for very high risk AML or MDS. Assessed by development of cytokine release syndrome (CRS) or graft-versus-host disease (GVHD) after adoptive immunotherapy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed GVHD by Severity | To assess the incidence and severity of Graft Versus Host Disease (GVHD), after conventional induction therapy followed by adoptive immunotherapy with NIMA compatible, IPA targeted CBU. | 6 months |
| Number of Participants With Detectable Cord Blood or Haploidentical Chimerism After Adoptive Immunotherapy |
Not provided
Inclusion Criteria:
Patients must be 18 years of age or older
Patients with a confirmed diagnosis of AML or MDS, according to World Health Organization (WHO) classification (excluding acute promyelocytic leukaemia) with recurrent or refractory disease as defined below.
For AML:
For MDS, either refractory anemia with excess blasts (RAEB) I or RAEB II who failed at least one chemotherapy regimen including either cytarabine or a hypomethylating agent.
Patients must have Karnofsky Performance score of ≥70
Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Gomez Arteaga, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33091124 | Derived | Chaekal OK, Scaradavou A, Masson Frenet E, Albano MS, Cushing M, Desai P, Dobrila L, Gergis U, Guarneri D, Hsu JM, Lee S, Mayer SA, Phillips AA, Orfali N, Ritchie EK, Roboz GJ, Romeo C, Samuel MS, Shore T, van Besien K. Adoptive immunotherapy with CB following chemotherapy for patients with refractory myeloid malignancy: chimerism and response. Blood Adv. 2020 Oct 27;4(20):5146-5156. doi: 10.1182/bloodadvances.2020002805. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cord Blood Unit | The CBU unit must supply a minimum of 0.5 x 10^7/kg and a maximum of 2.5 x 10^7/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will have also undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. CBU grafts in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x 10^7 nucleated blood cells/kg. umbilical cord blood unit (CBU): Treatment: The CBU unit must supply a minimum of 0.5 x107/kg and a maximum of 2.5x107/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci -. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will also have undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2022 |
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|
| umbilical cord blood unit (CBU) | Biological | Treatment: The CBU unit must supply a minimum of 0.5 x107/kg and a maximum of 2.5x107/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci -. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will also have undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. CBU grafts used in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x107 nucleated blood cells/kg |
|
| 6 months |
| Number of Participants With HLA-antibodies That Precluded Them From Moving Forward to Transplant | Count of participants with who developed HLA-antibodies that precluded them from moving forward to transplant | 6 months |
| Number of Participants Who Responded to Treatment | To assess response rates after adoptive immunotherapy. Response to treatment is defined as effective cytoreduction (ie, <5% residual blasts in a hypocellular bone marrow [BM] or no blasts in an acellular bone marrow [aplasia] obtained ∼14 days after infusion of the CB cells) | 6 months |
| Number of Participants That Underwent a Transplant After Response to Adoptive Immunotherapy | Number of participants that underwent a transplant after response to adoptive immunotherapy. Response to treatment is defined as effective cytoreduction (ie, <5% residual blasts in a hypocellular bone marrow [BM] or no blasts in an acellular bone marrow [aplasia] obtained ∼14 days after infusion of the CB cells) | 6 months |
| FG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cord Blood Unit | The CBU unit must supply a minimum of 0.5 x 10^7/kg and a maximum of 2.5 x 10^7/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will have also undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. CBU grafts in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x 10^7 nucleated blood cells/kg. umbilical cord blood unit (CBU): Treatment: The CBU unit must supply a minimum of 0.5 x107/kg and a maximum of 2.5x107/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci -. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will also have undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. |
| BG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
| 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 |
| ||||||||||||||||||
| Primary Malignancy | Count of Participants | 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 | Safety of Cellular Immunotherapy as Measured by the Number of Participants Who Developed of Cytokine Release Syndrome (CRS) or Graft-versus-host Disease (GVHD) After Adoptive Immunotherapy | Evaluate the safety of adoptive immunotherapy with Non-Inherited Maternal Antigen (NIMA) compatible, Inherited Paternal Antigen (IPA) targeted CBU or with haplo-identical stem cells after conventional induction therapy for very high risk AML or MDS. Assessed by development of cytokine release syndrome (CRS) or graft-versus-host disease (GVHD) after adoptive immunotherapy. | No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects. | Posted | Count of Participants | Participants | 6 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Developed GVHD by Severity | To assess the incidence and severity of Graft Versus Host Disease (GVHD), after conventional induction therapy followed by adoptive immunotherapy with NIMA compatible, IPA targeted CBU. | No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects. | Posted | Count of Participants | Participants | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Detectable Cord Blood or Haploidentical Chimerism After Adoptive Immunotherapy | No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects. | Posted | Count of Participants | Participants | 6 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HLA-antibodies That Precluded Them From Moving Forward to Transplant | Count of participants with who developed HLA-antibodies that precluded them from moving forward to transplant | No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects. | Posted | Count of Participants | Participants | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Responded to Treatment | To assess response rates after adoptive immunotherapy. Response to treatment is defined as effective cytoreduction (ie, <5% residual blasts in a hypocellular bone marrow [BM] or no blasts in an acellular bone marrow [aplasia] obtained ∼14 days after infusion of the CB cells) | No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects. | Posted | Count of Participants | Participants | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants That Underwent a Transplant After Response to Adoptive Immunotherapy | Number of participants that underwent a transplant after response to adoptive immunotherapy. Response to treatment is defined as effective cytoreduction (ie, <5% residual blasts in a hypocellular bone marrow [BM] or no blasts in an acellular bone marrow [aplasia] obtained ∼14 days after infusion of the CB cells) | No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects. | Posted | Count of Participants | Participants | 6 months |
|
6 months
No subjects were enrolled onto the Haploidentical arm due to graft selection criteria and suitable cord blood units being identified for subjects.
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 | Cord Blood Unit | The CBU unit must supply a minimum of 0.5 x 10^7/kg and a maximum of 2.5 x 10^7/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will have also undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. CBU grafts in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x 10^7 nucleated blood cells/kg. umbilical cord blood unit (CBU): Treatment: The CBU unit must supply a minimum of 0.5 x107/kg and a maximum of 2.5x107/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci -. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will also have undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. | 5 | 43 | 15 | 43 | 32 | 43 |
| EG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Acute Graft-versus-Host Disease | Investigations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fungal Pneumonia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fungal sinusitis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Multiorgan Failure | Investigations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Presacral Hematoma | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Post-Transplant Lymphoproliferative Disorder | Investigations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Vascular Access Complication | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Fistula | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| BK Viruria | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fungal Pneumonia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fungemia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin Cellulitis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Gomez Arteaga, MD | Weill Cornell Medicine | 646-962-7950 | alg9117@med.cornell.edu |
| Jan 18, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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 |
|
| Myelodysplastic Syndrome |
|
| Chronic Myelogenous Leukemia |
|
| OG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
|
|
| OG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
|
|
| OG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
|
|
| OG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
|
|
| OG001 | Haploidentical | Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.). Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment. haplo-identical cells (donor): Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment. |
|
|