Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Inclusion Criteria

Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
...
Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
Acute leukemia in 1st or 2nd CR
Patients must be willing to use contraception if they have childbearing potential
MDS (myelodysplastic syndrome), specific subtypes of RA (refractory anemia) or RARS (refractory anemia with ringed sideroblasts) subtypes.
Creatinine Clearance of ≥ 60 mL/min
HCT-CI Score ≤ 4 points for patients ≥ 60 years old or ≤ 5 points for patients < 60 years old.
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) ≥50% of predicted corrected for hemoglobin
LVEF (Left ventricular end diastolic function) of >50%
Aplastic Anemia
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.
Myeloproliferative disorders with at least a PR to current therapy
Hodgkin or Indolent Non-Hodgkin's lymphoma with chemosensitive disease
Performance status ≥ 80% (TJU Karnofsky) for patients ≥ 60 years old or ≥70% for patients < 60 years old.
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

Exclusion Criteria

Inability to obtain informed consent
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Hematopoietic Cell Transplant-Comorbidity Index (HCT-CI) Score > 4 points for patients ≥ 60 years old or > 5 points for patients < 60.
...
Inability to obtain informed consent
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Hematopoietic Cell Transplant-Comorbidity Index (HCT-CI) Score > 4 points for patients ≥ 60 years old or > 5 points for patients < 60.
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
HIV positive
Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
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
Pregnancy
Active involvement of the central nervous system with malignancy

Summary

Conditions
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Grade 1 Follicular Lymphoma
  • Refractory Anemia With Ringed Sideroblasts
  • Previously Treated Myelodysplastic Syndromes
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Polycythemia Vera
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Chronic Myelomonocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Essential Thrombocythemia
  • Childhood Myelodysplastic Syndromes
  • Refractory Anemia
  • Primary Myelofibrosis
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Chronic Eosinophilic Leukemia
  • Mastocytosis
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Nodal Marginal Zone B-cell Lymphoma
  • Chronic Neutrophilic Leukemia
  • Secondary Myelodysplastic Syndromes
  • Recurrent Grade 2 Follicular Lymphoma
  • Waldenstrom Macroglobulinemia
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Childhood Acute Myeloid Leukemia in Remission
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Juvenile Myelomonocytic Leukemia
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Refractory Multiple Myeloma
  • Aplastic Anemia
  • Childhood Acute Lymphoblastic Leukemia in Remission
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

Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
...
Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy
A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR).
Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
Acute leukemia in 1st or 2nd CR
Patients must be willing to use contraception if they have childbearing potential
MDS (myelodysplastic syndrome), specific subtypes of RA (refractory anemia) or RARS (refractory anemia with ringed sideroblasts) subtypes.
Creatinine Clearance of ≥ 60 mL/min
HCT-CI Score ≤ 4 points for patients ≥ 60 years old or ≤ 5 points for patients < 60 years old.
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) ≥50% of predicted corrected for hemoglobin
LVEF (Left ventricular end diastolic function) of >50%
Aplastic Anemia
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.
Myeloproliferative disorders with at least a PR to current therapy
Hodgkin or Indolent Non-Hodgkin's lymphoma with chemosensitive disease
Performance status ≥ 80% (TJU Karnofsky) for patients ≥ 60 years old or ≥70% for patients < 60 years old.
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

Exclusion Criteria

Inability to obtain informed consent
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Hematopoietic Cell Transplant-Comorbidity Index (HCT-CI) Score > 4 points for patients ≥ 60 years old or > 5 points for patients < 60.
...
Inability to obtain informed consent
Performance status < 80% (TJU Karnofsky) for patients ≥ 60 years old or <70% for patients < 60.
Hematopoietic Cell Transplant-Comorbidity Index (HCT-CI) Score > 4 points for patients ≥ 60 years old or > 5 points for patients < 60.
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
HIV positive
Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder
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
Pregnancy
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