RIC Transplant Using Haplo Donors



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 75
Updated:12/13/2018
Start Date:October 26, 2015
End Date:October 2019

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Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies

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.

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

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
We found this trial at
1
site
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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mi
from
Atlanta, GA
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