Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Inclusion Criteria

Myeloproliferative disorders with at least a PR to current therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Summary section).
...
Myeloproliferative disorders with at least a PR to current therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Summary section).
Able to give informed consent
Patients must be willing to use contraception if they have childbearing potential
Any patient with hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients treated on this protocol will be without morphological evidence of disease (complete remission or "CR"), or if the patient has evidence of disease, the patient must have had at least a good partial response (PR) to the most recent therapy and the disease must be chemoresponsive.
Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy
LVEF (Left ventricular end diastolic function) of >50%
MDS (myelodysplastic syndrome), specific subtypes of RA (refractory anemia) or RARS (refractory anemia with ringed sideroblasts) subtypes.
Creatinine Clearance of ≥ 60 mL/min
Hodgkin or Indolent Non-Hodgkin's lymphoma with chemosensitive disease
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) ≥50% of predicted corrected for hemoglobin
HCT-CI Score ≤ 4 points for patients ≥ 60 years old or ≤ 5 points for patients < 60 years old.
Aplastic Anemia
Performance status ≥ 80% (TJU Karnofsky) for patients ≥ 60 years old or ≥70% for patients < 60 years old.
Acute leukemia in 1st or 2nd CR

Exclusion Criteria

Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an anti-thymocyte globulin level of > 2 ugm/ml
...
Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an anti-thymocyte globulin level of > 2 ugm/ml
Hematopoietic Cell Transplant-Comorbidity Index (HCT-CI) Score > 4 points for patients ≥ 60 years old or > 5 points for patients < 60.
Pregnancy
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Inability to obtain informed consent
HIV positive
Active involvement of the central nervous system with malignancy

Summary

Conditions
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Juvenile Myelomonocytic Leukemia
  • Previously Treated Myelodysplastic Syndromes
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Refractory Multiple Myeloma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Grade 1 Follicular Lymphoma
  • Mastocytosis
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Waldenstrom Macroglobulinemia
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Refractory Anemia
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Essential Thrombocythemia
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Refractory Anemia With Ringed Sideroblasts
  • Chronic Neutrophilic Leukemia
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Polycythemia Vera
  • Recurrent Grade 2 Follicular Lymphoma
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Chronic Eosinophilic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Recurrent Marginal Zone Lymphoma
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Recurrent Childhood Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Primary Myelofibrosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Acute Myeloid Leukemia
  • Childhood Acute Myeloid Leukemia in Remission
  • Nodal Marginal Zone B-cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Aplastic Anemia
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Hairy Cell Leukemia
  • T-cell Large Granular Lymphocyte Leukemia
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

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

Description

PRIMARY OBJECTIVES: I. To compare the overall survival (OS) rate at 2 years post treatment using the Jefferson 2 step reduced intensity conditioning (RIC) approach in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemose...

PRIMARY OBJECTIVES: I. To compare the overall survival (OS) rate at 2 years post treatment using the Jefferson 2 step reduced intensity conditioning (RIC) approach in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemosensitive, indolent diseases to historical OS rates in similar populations after RIC matched donor HSCT as reported in the literature. SECONDARY OBJECTIVES: I. To compare the treatment-related mortality (TRM) rate at 2 years for patients treated on this study to the historical TRM rates of patients undergoing RIC matched-sibling HSCT as reported in the literature. II. To compare the 2 year relapse rates and relapse related mortality of patients with myeloid diseases to that of patients with lymphoid diseases who are treated on this Thomas Jefferson University (TJU) RIC 2 step approach. III. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the TJU RIC 2 step approach. IV. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach. V. To evaluate the incidence of TRM at 100 days in patients treated on the TJU RIC 2 step approach. OUTLINE: REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -11 to -8 and bulsufan IV over 3 hours on days -10 to -9. Patients undergo total body irradiation (TBI) on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo donor lymphocyte infusion (DLI) on day -6 and cluster of differentiation (CD)-34+ allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or orally (PO) with taper beginning on day 42. Patients also receive mycophenolate mofetil IV twice daily (BID) on days -1 to 28. After completion of study treatment, patients are followed up periodically for 2 years.

Inclusion Criteria

Myeloproliferative disorders with at least a PR to current therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Summary section).
...
Myeloproliferative disorders with at least a PR to current therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Summary section).
Able to give informed consent
Patients must be willing to use contraception if they have childbearing potential
Any patient with hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients treated on this protocol will be without morphological evidence of disease (complete remission or "CR"), or if the patient has evidence of disease, the patient must have had at least a good partial response (PR) to the most recent therapy and the disease must be chemoresponsive.
Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy
LVEF (Left ventricular end diastolic function) of >50%
MDS (myelodysplastic syndrome), specific subtypes of RA (refractory anemia) or RARS (refractory anemia with ringed sideroblasts) subtypes.
Creatinine Clearance of ≥ 60 mL/min
Hodgkin or Indolent Non-Hodgkin's lymphoma with chemosensitive disease
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) ≥50% of predicted corrected for hemoglobin
HCT-CI Score ≤ 4 points for patients ≥ 60 years old or ≤ 5 points for patients < 60 years old.
Aplastic Anemia
Performance status ≥ 80% (TJU Karnofsky) for patients ≥ 60 years old or ≥70% for patients < 60 years old.
Acute leukemia in 1st or 2nd CR

Exclusion Criteria

Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an anti-thymocyte globulin level of > 2 ugm/ml
...
Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an anti-thymocyte globulin level of > 2 ugm/ml
Hematopoietic Cell Transplant-Comorbidity Index (HCT-CI) Score > 4 points for patients ≥ 60 years old or > 5 points for patients < 60.
Pregnancy
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Inability to obtain informed consent
HIV positive
Active involvement of the central nervous system with malignancy

Locations

Philadelphia, Pennsylvania, 19107
Philadelphia, Pennsylvania, 19107

Tracking Information

NCT #
NCT01384513
Collaborators
Not Provided
Investigators
  • Principal Investigator: Dolores Grosso, DNP, CRNP Sidney Kimmel Cancer Center at Thomas Jefferson University Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Dolores Grosso, DNP, CRNP Sidney Kimmel Cancer Center at Thomas Jefferson University Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University