Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
60

Inclusion Criteria

Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)
Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression < 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing
Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor
...
Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)
Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression < 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing
Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor
ECOG performance status <= 2, or Karnofsky/Lansky status >= 60
FEV1 and FVC >= 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation > 92% on room air
Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25%
AST and ALT <= 5 x institutional upper limit of normal
Any previous autologous transplant must have occurred > 3 months ago

Exclusion Criteria

Active extramedullary leukemia or active central nervous system (CNS) malignant disease
Uncontrolled active infection
Pregnancy or active breastfeeding
...
Active extramedullary leukemia or active central nervous system (CNS) malignant disease
Uncontrolled active infection
Pregnancy or active breastfeeding
Previous allogeneic transplant

Summary

Conditions
  • Chronic Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Chronic Myelomonocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Chronic Myeloproliferative Disorders
  • Essential Thrombocythemia
  • Prolymphocytic Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Plasma Cell Dyscrasia
  • Plasma Cell Leukemia
  • Plasma Cell Neoplasm
  • Polycythemia Vera
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

The main goal is to learn whether a drug called tacrolimus, which is an immune-lowering drug (an immunosuppressant) given after transplant to help prevent certain complications, can be given safely for a shorter period of time than it has been in the past. The experiences with immunosuppression dura...

The main goal is to learn whether a drug called tacrolimus, which is an immune-lowering drug (an immunosuppressant) given after transplant to help prevent certain complications, can be given safely for a shorter period of time than it has been in the past. The experiences with immunosuppression duration with other allogeneic HSCT platforms cannot be directly extrapolated to the high-dose posttransplantation cyclophosphamide platform (another type of immunosuppressant given after transplant to help prevent GVHD). There are presently no published data on the minimum required duration of tacrolimus after nonmyeloablative HSCT that includes high-dose Cy as part of postgrafting immunosuppression. The effectiveness of high-dose posttransplantation Cy in GVHD prevention, however, permits the investigation of this question. At the present time there are few or no cures for diseases studied on this trial outside of a bone marrow or peripheral blood transplant. The peripheral blood for this transplant comes from a relative who is a half-match or "haplo" match to the participant. Possible donors include parents, siblings, and children. In order to help the bone marrow grow, or "take", inside the body, participants will receive chemotherapy and radiation before the transplant. After the transplant participants will receive high doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system, such as tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of rejection of the peripheral blood graft.

Inclusion Criteria

Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)
Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression < 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing
Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor
...
Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)
Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression < 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing
Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor
ECOG performance status <= 2, or Karnofsky/Lansky status >= 60
FEV1 and FVC >= 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation > 92% on room air
Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25%
AST and ALT <= 5 x institutional upper limit of normal
Any previous autologous transplant must have occurred > 3 months ago

Exclusion Criteria

Active extramedullary leukemia or active central nervous system (CNS) malignant disease
Uncontrolled active infection
Pregnancy or active breastfeeding
...
Active extramedullary leukemia or active central nervous system (CNS) malignant disease
Uncontrolled active infection
Pregnancy or active breastfeeding
Previous allogeneic transplant

Locations

Baltimore, Maryland, 21287
Baltimore, Maryland, 21287

Tracking Information

NCT #
NCT02556931
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Amy E DeZern, MD 410-502-7208
  • Amy E DeZern, MD 410-502-7208