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Non-Myeloablative Conditioning With Allogeneic Peripheral Blood Progenitor Cell Transplantation Followed by Prophylactic Activated Donor Lymphocyte Infusion (DLI) for the Treatment of High Risk Acute Leukemia/MDS


Phase 1
18 Years
70 Years
Not Enrolling
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

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Trial Information

Non-Myeloablative Conditioning With Allogeneic Peripheral Blood Progenitor Cell Transplantation Followed by Prophylactic Activated Donor Lymphocyte Infusion (DLI) for the Treatment of High Risk Acute Leukemia/MDS


Inclusion Criteria:



Disease related Parameters The following categories of patients with High Risk Acute
Myelogenous Leukemia, MDS, or Acute Lymphoblastic Leukemia in first or second complete
remission, age less than 70 years old, who would be offered a traditional allogeneic stem
cell transplant but are ineligible for, or unwilling to undergo, Allo SCT, will be
eligible for this study.

High Risk AML in CR1 is defined as having one of the following:

- Intermediate or Poor risk cytogenetics at presentation; Extramedullary involvement
(other than CNS); High WBC at presentation (>20,000); AML evolving out of
Myelodysplasia, regardless of cytogenetics M3 in CR2 only

- Patients with residual myelodysplasia after induction chemotherapy for AML

- Patients who require a second course of induction chemotherapy to achieve remission
status are felt to be inherently at high risk and will be considered eligible for
this study

MDS-Patients deemed to have high risk MDS based on IPSS of >1.5 are eligible for this
study. Patients must have less than 5% blasts at time of study entry and may receive
induction chemotherapy prior to transplant.

High Risk Acute Lymphoblastic Leukemia pts in CR1 3.1.4 CR2 (including AML,M3) patients:
Patients with AML or ALL who have relapsed and have received salvage chemotherapy at the
discretion of their primary physician and meet criteria for CR2 are eligible

Not a candidate for standard myeloablative conditioning with allotransplantation. Patients
are typically ineligible for standard allo SCT because of age greater than 50, or because
of co-morbid disease that precludes myeloablative conditioning (such as coronary artery
disease or cardiomyopathy, poor pulmonary function, or other medical disorders that, in
the opinion of the patients transplant physician, would result in unacceptable toxicity
from standard myeloablative conditioning with allogeneic transplantation).

Patient-related Parameters:

- Patients must have a healthy histocompatible donor (A, B and DR match); either
sibling or unrelated volunteer identified through the NMDP

- Age between 18 and 70 years old

- Life expectancy greater than 3 months.

- ECOG performance status 0-1.

- Patients must have acceptable organ function: - total bilirubin <2.0 - AST and ALT <
3 x normal, unless increases are thought to be either from non-hepatic causes (i.e
hemolysis) or related to underlying disease (such as liver involvement with
leukemia); creatinine <2.0 or creatinine clearance >40 ml/min (calculated or
collected); Cardiac: An ejection fraction >40% on MUGA or echocardiogram; Pulmonary:
corrected DLCO >50%

Exclusion Criteria:

Subjects:

- Patients may not have had chemotherapy or radiotherapy within 4 weeks prior to
entering the study. Patients must have recovered from adverse events due to agents
administered more than 4 weeks earlier.

- Patients may not have uncontrolled or untreated central nervous system involvement

- Patients may not have uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements.

- HIV positive patients are excluded

- The effects of these chemotherapy agents are likely to be harmful to a developing
human fetus. For this reason, women of child-bearing potential and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation.

- Pregnant women are excluded from this study because the chemotherapy is potentially
teratogenic or has abortifacient effects. Because there is an unknown but potential
risk for adverse events in nursing infants secondary to treatment of the mother with
chemotherapy, patients who are breastfeeding should discontinue breastfeeding or will
be excluded from this trial

- Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with chemotherapy, patients who are
breastfeeding should discontinue breastfeeding or will be excluded from this trial

Donors:

- Sibling donors will be evaluated according to the standard practice of the University
of Pennsylvania Bone Marrow and Stem Cell Transplant Program

- Unrelated donor evaluations and consent will be performed by an NMDP donor center
according to standard guidelines and procedures.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety and feasibility of administering prophylactic donor lymphocyte infusion (DLI) after non-myeloablative transplant (NMT).

Outcome Time Frame:

Six months after last patient entered on study.

Safety Issue:

Yes

Principal Investigator

Steven Goldstein, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 08405

NCT ID:

NCT00374933

Start Date:

April 2007

Completion Date:

December 2009

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • AML
  • ALL
  • MDS
  • Allogeneic transplant
  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • Adoptive cell therapy
  • Non-myeloablative
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Abramson Cancer Center at University of PennsylvaniaPhiladelphia, Pennsylvania  19104