Recruitment

Recruitment Status
Not yet recruiting

Inclusion Criteria

Myelofibrosis
Acute lymphoid leukemia in remission
Chronic myeloid leukemia
...
Myelofibrosis
Acute lymphoid leukemia in remission
Chronic myeloid leukemia
Acute myeloid leukemia
Chronic myelomonocytic leukemia
Left ventricular ejection fraction of >= 50%
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.
Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement
Myeloid malignancy not otherwise specified
Myelodysplasia (MDS)
Multiple myeloma
Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
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 aged 60 to 65 years must have a KPS of >= 80% and an HCT-CI score of 4 or less
Patient or patient's guardian is able to give informed consent
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
Hodgkin or non-Hodgkin lymphoma
Small lymphocytic lymphoma/CLL
Essential thrombocytopenia or polycythemia vera
T cell lymphoma without significant lymph node disease burden
Creatinine clearance of >= 60 mL/min
T cell leukemia
(Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator and at least 1 co-investigator 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 should have a life expectancy of >= 6 months for reasons other than their underlying hematologic/oncologic disorder
Patients < age 60 years must have a KPS of >= 80% and an HCT-CI score of 5 or less
Diffusion lung capacity of oxygen >= 50% and forced expiratory volume at 1 second >= 50% of predicted corrected for hemoglobin
Patients must be willing to use contraception if they have childbearing potential
Adequate liver function as defined by a serum bilirubin =< 1.8, aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal

Exclusion Criteria

Human immunodeficiency virus positive
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
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
...
Human immunodeficiency virus positive
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
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

Summary

Conditions
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Aplastic Anemia
  • Chronic Lymphocytic Leukemia
  • Non Hodgkin Lymphoma
  • Chronic Myelomonocytic Leukemia
  • Essential Thrombocythemia
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Hodgkin Lymphoma
  • Plasma Cell Myeloma
  • Small Lymphocytic Lymphoma
  • Myelodysplastic Syndromes
  • Polycythemia Vera
  • Myelofibrosis
  • Myeloid Leukemia
  • Myeloid Neoplasm
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 proto...

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

Inclusion Criteria

Myelofibrosis
Acute lymphoid leukemia in remission
Chronic myeloid leukemia
...
Myelofibrosis
Acute lymphoid leukemia in remission
Chronic myeloid leukemia
Acute myeloid leukemia
Chronic myelomonocytic leukemia
Left ventricular ejection fraction of >= 50%
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.
Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement
Myeloid malignancy not otherwise specified
Myelodysplasia (MDS)
Multiple myeloma
Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
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 aged 60 to 65 years must have a KPS of >= 80% and an HCT-CI score of 4 or less
Patient or patient's guardian is able to give informed consent
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
Hodgkin or non-Hodgkin lymphoma
Small lymphocytic lymphoma/CLL
Essential thrombocytopenia or polycythemia vera
T cell lymphoma without significant lymph node disease burden
Creatinine clearance of >= 60 mL/min
T cell leukemia
(Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator and at least 1 co-investigator 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 should have a life expectancy of >= 6 months for reasons other than their underlying hematologic/oncologic disorder
Patients < age 60 years must have a KPS of >= 80% and an HCT-CI score of 5 or less
Diffusion lung capacity of oxygen >= 50% and forced expiratory volume at 1 second >= 50% of predicted corrected for hemoglobin
Patients must be willing to use contraception if they have childbearing potential
Adequate liver function as defined by a serum bilirubin =< 1.8, aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal

Exclusion Criteria

Human immunodeficiency virus positive
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
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
...
Human immunodeficiency virus positive
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
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

Locations

Philadelphia, Pennsylvania, 19107
Philadelphia, Pennsylvania, 19107

Tracking Information

NCT #
NCT05031897