Two Step Haplo With Radiation Conditioning

A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Polycythemia Vera; Essential Thrombocythemia; Multiple Myeloma; Hodgkin Lymphoma; Myelofibrosis; Chronic Myelomonocytic Leukemia; Acute Lymphoblastic Leukemia; Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma; Myelodysplastic Syndrome; Aplastic Anemia; Adult T-Cell Leukemia/Lymphoma; Small Lymphocytic Lymphoma; Myeloid Neoplasm; Chronic Myeloid Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Melphalan; Radiation: Total-Body Irradiation; Procedure: Hematopoietic Cell Transplantation; Drug: Mycophenolate Mofetil; Drug: Tacrolimus; Procedure: Donor Lymphocyte Infusion; Procedure: Diagnostic Imaging; Procedure: Bone Marrow Aspiration and Biopsy

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the 2 year cumulative incidence of TRM in patients undergoing reduced intensity conditioning (RIC) haploidentical (HI) HSCT in this protocol.

SECONDARY OBJECTIVES:

I. To assess the 2 year cumulative incidence of relapse in patients undergoing RIC HI HSCT in this protocol.

II. To assess the consistency and pace of engraftment. III. To assess the pace of T cell and B cell immune recovery. IV. To assess the incidence and severity of graft versus host disease (GVHD).

OUTLINE: Patients are assigned to 1 of 2 cohorts.

RADIATION-BASED COHORT: Patients receive fludarabine intravenously (IV) on days -11, -10, -9, and -8, undergo total-body irradiation (TBI) twice a day (BID) on days -10 and -9, undergo donor lymphocyte infusion (DLI) on day -6, and receive cyclophosphamide IV on days -3 and -2. Patients begin tacrolimus and mycophenolate mofetil IV on day -1. Patients then undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy/aspiration, imaging and blood sample collection throughout the study.

CHEMOTHERAPY-BASED COHORT: Patients receive fludarabine IV on days -11, -10, -9, and -8 and melphalan IV on days -10 and -9. Patients undergo TBI and DLI once on day -6. Patients receive cyclophosphamide IV on days -3 and -2 and begin tacrolimus and mycophenolate mofetil on day -1. Patients undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy/aspiration, imaging and blood sample collection throughout the study.

After completion of study treatment, patients are followed for 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Usama Gergis, MD; Phone Number: 215-503-2455; Email: usama.gergis@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadephia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Contact: Usama Gergis, MD; Phone Number: 215-503-2455; Email: usama.gergis@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Radiation-based cohort diagnoses:

  • Acute myeloid leukemia
  • Acute lymphoid leukemia in remission
  • Myelodysplasia (MDS)
  • Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement
  • Multiple myeloma
  • Chronic myeloid leukemia
  • Myelofibrosis
  • Myeloid malignancy not otherwise specified
  • Chronic myelomonocytic leukemia
  • Essential thrombocytopenia or polycythemia vera
  • T cell leukemia
  • T cell lymphoma without significant lymph node disease burden
  • Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable
  • Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen.
  • Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)

• Chemotherapy-based cohort diagnoses:

  • Hodgkin or non-Hodgkin lymphoma
  • Small lymphocytic lymphoma/CLL
  • Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease
  • Hematological malignancy in patients who cannot receive > 2 Gy radiation
  • Aplastic anemia and other non-malignant hematologic dyscrasias
  • Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)

• Human leukocyte antigen (HLA) identical cohort diagnoses:

  * Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls into. However, these patients will have HLA identical related donors (one-antigen cross-over event included).

• Left ventricular ejection fraction of >= 50%
• Diffusion lung capacity of oxygen >= 50% and forced expiratory volume at 1 second >= 50% of predicted corrected for hemoglobin
• Serum bilirubin =< 1.8
• Aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal
• Creatinine clearance of >= 60 mL/min

• Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores:

  • Patients < age 60 years must have a KPS of >= 60% and an HCT-CI score of 5 or less
  • Patients aged 60 to 65 years must have a KPS of >= 60% and an HCT-CI score of 4 or less
  • Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less
  • Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less
  • (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the patient). This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities
• Patients must be willing to use contraception if they have childbearing potential
• Patient or patient's guardian is able to give informed consent
• Patients should have a life expectancy of >= 6 months for reasons other than their underlying hematologic/oncologic disorder
• Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol

• Patients should not be:

  • Human immunodeficiency virus positive
  • Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and/or a negative cerebral spinal fluid analysis
• Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Radiation-Based Cohort (fludarabine, TBI, infusion); Patients receive fludarabine IV on days -11, -10, -9, and -8, undergo TBI BID on days -10 and -9, undergo DLI on day -6, and receive cyclophosphamide IV on days -3 and -2. Patients begin tacrolimus and mycophenolate mofetil IV on day -1. Patients then undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy/aspiration, imaging and blood sample collection throughout the study.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Cyclophosphamide; Given IV; Other Names: Cytoxan; CTX; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamide Monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cytophosphan; Cytophosphane; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate; 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate; 2-[bis(b-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane-2-oxide monohydrate; 2-[di(chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide monohydrate; 6055-19-2; bis(2-chloroethyl)phosphamide cyclic propanolamide ester monohydrate; Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester monohydrate; N,N-bis(2-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate; N,N-bis(b-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate; N,N-bis(beta-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate; N,N-bis(beta-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate; Asta B 518; B-518; WR-138719; B 518; B518; WR 138719; WR138719; N,N-bis(2-chloroethyl)-N'-(3-hydroxypropyl)phosphorodiamidic acid intramolecular ester monohydrate, N,N-bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide monohydrate; Drug: Fludarabine; Given IV; Other Names: Fluradosa; 2-Fluorovidarabine; 9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine; 9-Beta-D-arabinofuranosyl-2-fluoroadenine; 2-Fluoro-9-beta-arabinofuranosyladenine; 21679-14-1; Radiation: Total-Body Irradiation; Undergo TBI; Other Names: TBI; SCT_TBI; Whole Body Irradiation; Whole-Body Irradiation; Whole Body; TOTAL BODY IRRADIATION; Procedure: Hematopoietic Cell Transplantation; Undergo HSCT; Other Names: HSCT; HCT; Hematopoietic Stem Cell Transplantation; stem cell transplantation; Hematopoietic Stem Cell Infusion; Stem Cell Transplant; SCT; NOS; HEMATOPOIETIC STEM CELL TRANSPLANT; Drug: Mycophenolate Mofetil; Given IV; Other Names: Cellcept; MMF; 115007-34-6; 128794-94-5; Drug: Tacrolimus; Given IV; Other Names: Prograf; FK506; Hecoria; FK 506; Fujimycin; Protopic; FK-506; 109581-93-3; Tacforius; Procedure: Donor Lymphocyte Infusion; Undergo DLI; Other Names: DLI; Donor Leukocyte Infusion; Procedure: Diagnostic Imaging; Undergo diagnostic imaging; Other Names: Medical Imaging; Procedure: Bone Marrow Aspiration and Biopsy; Undergo bone marrow aspiration/ biopsy
Experimental: Arm 2: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI); Patients receive fludarabine IV on days -11, -10, -9, and -8 and melphalan IV on days -10 and -9. Patients undergo TBI and DLI once on day -6. Patients receive cyclophosphamide IV on days -3 and -2 and begin tacrolimus and mycophenolate mofetil on day -1. Patients undergo hematopoietic stem cell transplant on day 0. Patients undergo bone marrow biopsy/aspiration, imaging and blood sample collection throughout the study.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Cyclophosphamide; Given IV; Other Names: Cytoxan; CTX; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamide Monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cytophosphan; Cytophosphane; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate; 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate; 2-[bis(b-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane-2-oxide monohydrate; 2-[di(chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide monohydrate; 6055-19-2; bis(2-chloroethyl)phosphamide cyclic propanolamide ester monohydrate; Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester monohydrate; N,N-bis(2-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate; N,N-bis(b-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate; N,N-bis(beta-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate; N,N-bis(beta-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate; Asta B 518; B-518; WR-138719; B 518; B518; WR 138719; WR138719; N,N-bis(2-chloroethyl)-N'-(3-hydroxypropyl)phosphorodiamidic acid intramolecular ester monohydrate, N,N-bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide monohydrate; Drug: Fludarabine; Given IV; Other Names: Fluradosa; 2-Fluorovidarabine; 9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine; 9-Beta-D-arabinofuranosyl-2-fluoroadenine; 2-Fluoro-9-beta-arabinofuranosyladenine; 21679-14-1; Drug: Melphalan; Given IV; Other Names: CB-3025; L-PAM; L-Sarcolysin; Alanine Nitrogen Mustard; L-Sarcolysin Phenylalanine mustard; L-Sarcolysine; Melphalanum; Phenylalanine Mustard; Sarcoclorin; Sarkolysin; WR-19813; Phenylalanine nitrogen mustard; L-Phenylalanine mustard; 148-82-3; Melphalan for Injection-Hepatic Delivery System; 4-[bis(2-chloroethyl)amino]-L-phenylalanine; p-di(chloroethyl)amino-L-phenylalanine; Radiation: Total-Body Irradiation; Undergo TBI; Other Names: TBI; SCT_TBI; Whole Body Irradiation; Whole-Body Irradiation; Whole Body; TOTAL BODY IRRADIATION; Procedure: Hematopoietic Cell Transplantation; Undergo HSCT; Other Names: HSCT; HCT; Hematopoietic Stem Cell Transplantation; stem cell transplantation; Hematopoietic Stem Cell Infusion; Stem Cell Transplant; SCT; NOS; HEMATOPOIETIC STEM CELL TRANSPLANT; Drug: Mycophenolate Mofetil; Given IV; Other Names: Cellcept; MMF; 115007-34-6; 128794-94-5; Drug: Tacrolimus; Given IV; Other Names: Prograf; FK506; Hecoria; FK 506; Fujimycin; Protopic; FK-506; 109581-93-3; Tacforius; Procedure: Donor Lymphocyte Infusion; Undergo DLI; Other Names: DLI; Donor Leukocyte Infusion; Procedure: Diagnostic Imaging; Undergo diagnostic imaging; Other Names: Medical Imaging; Procedure: Bone Marrow Aspiration and Biopsy; Undergo bone marrow aspiration/ biopsy
Experimental: Arm 3: HLA- Identical cohort (radiation-based or chemotherapy-based conditioning); This group (HLA- Identical cohort), which is expected to be small, can undergo HSCT with radiation-based or chemotherapy-based conditioning. Due to small numbers of patients with available HLA identical related donors, this third, descriptive arm is included so that this group, too small in number for a free-standing study, are treated on clinical trial. This is also a separate arm of the study and the outcome of patients treated on this arm will be analyzed descriptively without statistical comparison or power analysis.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Cyclophosphamide; Given IV; Other Names: Cytoxan; CTX; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamide Monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cytophosphan; Cytophosphane; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate; 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate; 2-[bis(b-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane-2-oxide monohydrate; 2-[di(chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide monohydrate; 6055-19-2; bis(2-chloroethyl)phosphamide cyclic propanolamide ester monohydrate; Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester monohydrate; N,N-bis(2-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate; N,N-bis(b-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate; N,N-bis(beta-chloroethyl)-N',O-propylenephosphoric acid ester diamide monohydrate; N,N-bis(beta-chloroethyl)-N',O-trimethylenephosphoric acid ester diamide monohydrate; Asta B 518; B-518; WR-138719; B 518; B518; WR 138719; WR138719; N,N-bis(2-chloroethyl)-N'-(3-hydroxypropyl)phosphorodiamidic acid intramolecular ester monohydrate, N,N-bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide monohydrate; Drug: Fludarabine; Given IV; Other Names: Fluradosa; 2-Fluorovidarabine; 9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine; 9-Beta-D-arabinofuranosyl-2-fluoroadenine; 2-Fluoro-9-beta-arabinofuranosyladenine; 21679-14-1; Drug: Melphalan; Given IV; Other Names: CB-3025; L-PAM; L-Sarcolysin; Alanine Nitrogen Mustard; L-Sarcolysin Phenylalanine mustard; L-Sarcolysine; Melphalanum; Phenylalanine Mustard; Sarcoclorin; Sarkolysin; WR-19813; Phenylalanine nitrogen mustard; L-Phenylalanine mustard; 148-82-3; Melphalan for Injection-Hepatic Delivery System; 4-[bis(2-chloroethyl)amino]-L-phenylalanine; p-di(chloroethyl)amino-L-phenylalanine; Radiation: Total-Body Irradiation; Undergo TBI; Other Names: TBI; SCT_TBI; Whole Body Irradiation; Whole-Body Irradiation; Whole Body; TOTAL BODY IRRADIATION; Procedure: Hematopoietic Cell Transplantation; Undergo HSCT; Other Names: HSCT; HCT; Hematopoietic Stem Cell Transplantation; stem cell transplantation; Hematopoietic Stem Cell Infusion; Stem Cell Transplant; SCT; NOS; HEMATOPOIETIC STEM CELL TRANSPLANT; Drug: Mycophenolate Mofetil; Given IV; Other Names: Cellcept; MMF; 115007-34-6; 128794-94-5; Drug: Tacrolimus; Given IV; Other Names: Prograf; FK506; Hecoria; FK 506; Fujimycin; Protopic; FK-506; 109581-93-3; Tacforius; Procedure: Donor Lymphocyte Infusion; Undergo DLI; Other Names: DLI; Donor Leukocyte Infusion; Procedure: Diagnostic Imaging; Undergo diagnostic imaging; Other Names: Medical Imaging; Procedure: Bone Marrow Aspiration and Biopsy; Undergo bone marrow aspiration/ biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience Treatment-Related Mortality (TRM)	TRM is defined as death without evidence of recurrent disease in the 2 year period post HSCT. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.	At 2 years post hematopoietic stem cell transplant (HSCT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of relapsed disease	Relapse is measured by evidence of recurrent disease in the blood, marrow, or lymph nodes. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.	Up to 2 years
Engraftment	Measure by chimerism studies of the blood and marrow at multiple time points after the HSCT. Chimerism refers to the percentage of donor cells in the hematopoietic system of the patient post HSCT. Reported using mean and standard deviations.	Up to 2 years
Immune reconstitution	Evaluated by T-cell recovery and B-cell recovery. Assessed by the quantitative measurement of CD3/4 and CD3/8 cells and immunoglobulin levels in the blood at multiple time points post HSCT. CD3/4 and CD3/8 counts are measured by an immune reconstitution panel and immunoglobulin levels are measured by a quantitative immunoglobulin assay. Reported using mean and standard deviations	Up to 2 years
Incidence and degree of graft versus host disease (GVHD) after HSCT	Assessment includes presence and degree of skin rash, presence and amount of diarrhea, and/or abnormal liver function test. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.	Up to 2 years

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Usama Gergis, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Failure Disorders; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Blood Coagulation Disorders; Lymphoma; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Anemia; Leukemia, Lymphoid; Leukemia; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Thrombocytosis; Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelomonocytic, Chronic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Multiple Myeloma; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Hodgkin Disease; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Aplastic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Thrombocythemia, Essential; Polycythemia Vera; Primary Myelofibrosis; Amino Acids, Peptides, and Proteins; Organic Chemicals; Investigative Techniques; Therapeutics; Fatty Acids; Lipids; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Hydrocarbons; Physical Phenomena; Acids, Acyclic; Carboxylic Acids; Transplantation; Amino Acids; Diagnostic Techniques, Surgical; Macrolides; Lactones; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Electromagnetic Phenomena; Magnetic Phenomena; Radiotherapy; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Caproates; Cyclophosphamide; Melphalan; Mycophenolic Acid; Tacrolimus; Biopsy; Specimen Handling; fludarabine; fludarabine phosphate; Stem Cell Transplantation; Hematopoietic Stem Cell Transplantation; X-Rays; Whole-Body Irradiation
• Other Study ID Numbers: 21D.466; JT 15545 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No