Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MT2016-15 | Other Identifier | University of Minnesota Blood and Marrow Transplant Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) >3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Haplo-HCT <55 years old | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 |
|
| CLOSED Arm B: Haplo-HCT ≥55 years old | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. |
|
| Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. |
|
| Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3 | Experimental | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haplo HCT <55 years old | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD) | Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD). | day 100 |
| Treatment Related Mortality (TRM) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Criteria For Donor Selection:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Najla El Jurdi, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Haplo-HCT <55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT <55 years old: - Fludarabine (Flu)
GVHD Prophylaxis: - Cyclophosphamide (Cy)
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Mar 11, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Haplo HCT ≥55 years old | Biological |
|
|
|
| GVHD Prophylaxis | Drug |
|
|
| Haplo HCT ≥55 and < 65 years old | Biological |
|
|
|
| Haplo HCT ≥65 and ≤75 years old | Biological |
|
|
|
Percentage of participants experiencing treatment related mortality (TRM).
| 6 month, 1 and 2 year |
| Relapse Incidence | Percentage of participants experiencing a relapse incidence at 1 and 2 years. | 1 and 2 year |
| Incidence of Serious Fungal and Viral Infection | Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT | at day 100 and 1 year |
| FG001 | CLOSED Arm B: Haplo-HCT ≥55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu)
GVHD Prophylaxis: - Cyclophosphamide (Cy)
|
| FG002 | Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
|
| FG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Haplo-HCT <55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT <55 years old: - Fludarabine (Flu)
GVHD Prophylaxis: - Cyclophosphamide (Cy)
|
| BG001 | CLOSED Arm B: Haplo-HCT ≥55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu)
GVHD Prophylaxis: - Cyclophosphamide (Cy)
|
| BG002 | Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
|
| BG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
|
| BG004 | 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 | Disease-free Survival (DFS) | Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD) | Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD). | Posted | Number | 95% Confidence Interval | Percentage of participants | day 100 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Related Mortality (TRM) | Percentage of participants experiencing treatment related mortality (TRM). | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 month, 1 and 2 year |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Relapse Incidence | Percentage of participants experiencing a relapse incidence at 1 and 2 years. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 and 2 year |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Serious Fungal and Viral Infection | Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT | Posted | Number | 95% Confidence Interval | Percentage of participants | at day 100 and 1 year |
|
2 years
Not provided
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 | Arm A: Haplo-HCT <55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT <55 years old: - Fludarabine (Flu)
GVHD Prophylaxis: - Cyclophosphamide (Cy)
| 6 | 14 | 6 | 14 | 10 | 14 |
| EG001 | CLOSED Arm B: Haplo-HCT ≥55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu)
GVHD Prophylaxis: - Cyclophosphamide (Cy)
| 13 | 21 | 9 | 21 | 11 | 21 |
| EG002 | Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
| 5 | 8 | 4 | 8 | 6 | 8 |
| EG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
| 18 | 35 | 11 | 35 | 15 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious bacterial Infection | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fungal Infection | Infections and infestations | Fungal Infection | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | Viral Infection | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Juckett, MD | University of Minnesota, Masonic Cancer Center | (612) 626-5654 | juck0001@umn.edu |
| Mar 11, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2024 | Mar 11, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D018365 | Neoplasm, Residual |
| D007938 | Leukemia |
| D009196 | Myeloproliferative Disorders |
| D055728 | Primary Myelofibrosis |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D020522 | Lymphoma, Mantle-Cell |
| D006689 | Hodgkin Disease |
| D002051 | Burkitt Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D009101 | Multiple Myeloma |
| D000080983 | Bone Marrow Failure Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=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 |
|
| Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo |
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
|
| OG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
|
|
|
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
|
| OG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
|
|
|
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
|
| OG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
|
|
|
| Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo |
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥55 and < 65 years old: - Fludarabine (Flu)
|
| OG003 | Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy)
Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)
|
|
|