Reduced Intensity Conditioning Transplant Using Haploidentical Donors

Northside Hospital, Inc.

Status and phase

Completed

Phase 2

Conditions

CMML

Myelofibrosis

Hodgkin's Lymphoma

Acute Lymphocytic Leukemia

Multiple Myeloma

Acute Myelogenous Leukemia

Non-Hodgkin's Lymphoma

Chronic Myelogenous Leukemia

Chronic Lymphocytic Leukemia

Myelodysplastic Syndrome

Treatments

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Melphalan

Procedure: peripheral blood stem cell transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT02581007

NSH 1132

Details and patient eligibility

About

This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.

Full description

Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive regimen. Patients will get cyclophosphamide on days 3 & 4 post-transplant.

Enrollment

25 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

No available matched related or unrelated donor, OR a matched related or unrelated donor will not be available in time frame necessary to perform potentially curative transplant
Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor (donor must have negative HLA cross-match in host vs. graft direction)
Karnofsky status ≥70%
One of the following high-risk malignancies:
1. Chronic Myelogenous Leukemia: Chronic myelogenous leukemia in chronic phase, resistant or intolerant to available tyrosine kinase inhibitors; Chronic myelogenous leukemia in accelerated phase; Chronic myelogenous leukemia with blast crisis that has entered into a second chronic phase following induction chemotherapy
2. Acute Myelogenous Leukemia in first or greater remission
3. Myelodysplastic Syndrome at least one of the following: treatment-related; monosmy 7, complex cytogenetics or other high risk karyotype; IPSS score of 1.0 or greater; neutropenia or cytopenia requiring transfusion not responding to therapy; peripheral or BM blast count of <10%; CMML
4. Acute lymphocytic leukemia/lymphoblastic lymphoma: 2nd or subsequent complete remission; first complete remission; marrow blasts <5%, but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
5. Chronic Lymphocytic Leukemia/Prolymphocytic Leukemia: previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
6. Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse): previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
7. Myeloproliferative diseases (myelofibrosis, CMML)
8. Multiple Myeloma with relapse after a prior autologous transplant or eligible for allogeneic HSCT based on other risk factors

Exclusion criteria

not be excluded on basis of sex, racial, or ethnic backgrounds
poor cardiac function: left ventricular ejection fraction <40%
poor pulmonary function: FEV1 and FVC <50% predicted
poor liver function: bilirubin >2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)
poor renal function: Creatinine >2.0mg/dl or creatinine clearance (calculated creatinine clearance is permitted) < 40 mL/min based on Traditional Cockcroft-Gault formula: 140 - age (yrs) x Smaller of Actual Weight vs. Ideal Body Weight (kg) / 72 x Serum creatinine (mg/dl)
HIV-positive
prior allogeneic transplant
women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up