An Early Phase 1 interventional study of Allogeneic Hematopoietic Stem Cell Transplantation and Irradiated Allogeneic Cells in Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia in Remission and Hematopoietic Cell Transplantation Recipient, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Rutgers, The State University of New Jersey · Early Phase 1, Interventional, and Treatment
This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.
PRIMARY OBJECTIVES:
I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies.
SECONDARY OBJECTIVES:
I. To determine if there is evidence of disease response associated with IHC.
TERTIARY OBJECTIVES:
I. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
After completion of study treatment, patients will be followed up within 8 weeks.
2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Rutgers, The State University of New Jersey is the lead sponsor of 504 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and ?high-risk? disease as defined below:
Multiple myeloma with ONE (or more) of the following high risk features:
COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor with one of the following disease subtypes:
Acute myeloid leukemia (AML) in CR1 with high risk features (European Leukemia Network [ELN]) at presentation
DONOR: Donor must meet all Robert Wood Johnson (RWJ) Blood Services requirements for hematopoietic stem cell donation including:
Exclusion Criteria:
Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Biological: Irradiated Allogeneic Cells
Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Biological: Irradiated Allogeneic Cells
Receive IHC
Also known as: Allogeneic Hematopoietic Cell Transplantation, allogeneic stem cell transplantation, HSC, HSCT
Correlative studies
Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: Up to 8 weeks after last protocol treatment
the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu
Time frame: Up to 12 weeks of completion of therapy
Induction of Host T Cells Reactive With Tumor Associated Epitopes
It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.
Time frame: Up to 8 weeks after last protocol treatment
| Milestone | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 2 |
| Not completed | 0 | 0 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
| Participants | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) |
|---|---|---|
| Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response | — | 2 |
The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu
| Participants | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) |
|---|---|---|
| the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | — | 2 |
It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.
No measurements were reported for this outcome.
Collected over Up to 8 weeks after last protocol treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort I (Initial IHC Within 42 Days) | — | — | — |
| Cohort II (Initial IHC Within 70 Days or After Relapse) | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) |
|---|---|---|
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | — | 0/2 |
| Event | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) |
|---|---|---|
| General disorders and administration site conditionsGeneral disorders | — | 2/2 |
| InvestigationsInvestigations | — | 2/2 |
| Eye disordersEye disorders | — | 1/2 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | — | 1/2 |
| Nervous system disordersNervous system disorders | — | 1/2 |
No participants qualified for cohort I
| Age, Categorical(Participants) | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 1 | 1 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 2 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort I (Initial IHC Within 42 Days) | Cohort II (Initial IHC Within 70 Days or After Relapse) | Total |
|---|---|---|---|
| United States | — | 2 | 2 |
Documents are hosted by the registry — open the source record to download them.
Ran from Oct 2020 to primary completion in Jun 2022, 20 months.
Results were first posted in Jun 2023, 11 months after primary completion.
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