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Phase II Related or Unrelated Allogeneic Hematopoietic Cell Transplantation for High-Risk Malignancies, Using a Preparative Regimen of Pentostatin (Nipent®) and Alemtuzumab (Campath®)

Phase 2
18 Years
75 Years
Not Enrolling
Leukemia, Lymphoma, Hodgkin's Disease, Hematologic Neoplasms, Multiple Myeloma, Carcinoma, Renal Cell

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Trial Information

Phase II Related or Unrelated Allogeneic Hematopoietic Cell Transplantation for High-Risk Malignancies, Using a Preparative Regimen of Pentostatin (Nipent®) and Alemtuzumab (Campath®)

Primary Objectives of the study:

- To determine the efficacy of a preparative regimen of pentostatin and alemtuzumab plus
related or unrelated allogeneic peripheral blood stem cell transplantation (PBSCT) in
inducing durable donor lymphohematopoietic cell chimerism (defined as at least 50%
donor cells in the peripheral blood) by 100 days after PBSCT (day +100) in subjects
with high-risk malignancies who are at high risk for morbidity and mortality with
conventional intensive pre-transplant conditioning regimens.

- To determine the safety of a preparative regimen of pentostatin and alemtuzumab plus
related or unrelated allogeneic PBSCT, as measured by the non-relapse mortality at day
+100 in the study subject population.

Inclusion Criteria:

One of these diagnoses:

- Acute myeloid leukemia in complete or partial remission

- Acute lymphocytic leukemia in complete or partial remission

- Chronic myeloid leukemia in first or subsequent chronic phase or accelerated phase

- Chronic lymphocytic leukemia that has recurred or failed after at least one course of
front-line therapy

- Hodgkin's disease or non-Hodgkin's lymphoma that has failed front-line therapy, is in
second or subsequent remission, or is in chemosensitive relapse

- Multiple myeloma that is in complete or partial remission or in chemosensitive

- Myelodysplastic Syndrome classified as intermediate-2 or high risk according to
International Prognostic Scoring System

- Metastatic renal cell carcinoma that has failed at least one previous front-line
chemotherapy and/or biological therapy regimen and that is radiographically
detectable and evaluable

- Treatment with at least one previous course of chemotherapy or biological therapy for
the malignancy for which allogeneic PBPCT is being considered (i.e., a subject cannot
be enrolled on this study for initial treatment of a malignancy).

AND at least one of the following:

- Age 50 years or older.

- Previous transplant with autologous or allogeneic hematopoietic cells (peripheral
blood, bone marrow, or placental blood).

- High-risk status of hematologic malignancy, i.e., not in first complete remission or
first chronic phase.

- Presence of other medical condition that could place subject at unacceptably high
risk of regimen-related mortality such as documented chronic bronchitis or emphysema;
decreased cardiac ejection fraction (but with ejection fraction at least 30%), or
history of coronary artery disease; renal insufficiency (but with creatinine
clearance at least 30 mL/min); hepatic cirrhosis (but with normal hepatic synthetic
function); or documented or presumed invasive fungal infection requiring treatment
with intravenous antifungal agent(s).

Exclusion Criteria:

- Eligibility for another clinical therapeutic protocol or standard-of-care treatment
that offers higher probability of cure or long-term control of subject's malignancy.

- Progressive Hodgkin's disease, non-Hodgkin's lymphoma, Hodgkin disease or multiple
myeloma that is refractory to salvage chemotherapy.

- Acute leukemia (AML or ALL) in relapse, CML in blast phase/blast crisis, or MDS with
greater than 30% marrow involvement (MDS-AML). Subjects with these disease
characteristics may be considered for this study if complete or partial remissions
(CRs or PRs) occur after salvage chemotherapy.

- Severe organ dysfunction, such as: cardiac ejection fraction below 30% or symptomatic
ischemic cardiac disease; creatinine clearance below 30 mL/min; carbon monoxide
diffusing capacity (DLCO) below 35% and/or need for supplemental oxygen; severe
hepatic cirrhosis with ascites and/or varices; hepatic dysfunction associated with
abnormal synthetic function (e.g., coagulopathy) and/or bilirubin greater than two
times upper limit of normal and/or transaminases (AST or ALT) above four times upper
limit of normal.

- Untreated or progressive central nervous system involvement by malignancy

- Subject is pregnant or breast-feeding.

- Karnofsky score below 50

- Seropositivity for human immunodeficiency virus (HIV).

- Life expectancy less than 12 weeks with conventional treatments.

- For subjects who are fertile, refusal to practice contraception upon entering this
study and for at least 12 months after PBPCT or after cessation of immunosuppressive
treatments (e.g., cyclosporine), whichever occurs later.

- Failure to obtain at least 5.0 x 106 allogeneic donor CD34+ cells per kg of recipient
weight in PBPC product.

Type of Study:


Study Design:

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

Outcome Measure:

Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).

Outcome Description:

The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.

Outcome Time Frame:

Day 100 after transplant.

Safety Issue:


Principal Investigator

Andrew M Yeager, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

November 2010

Related Keywords:

  • Leukemia
  • Lymphoma
  • Hodgkin's Disease
  • Hematologic Neoplasms
  • Multiple Myeloma
  • Carcinoma, Renal Cell
  • Allogeneic Hematopoietic Cell Transplantation
  • Preparative Regimen
  • Pentostatin
  • Alemtuzumab
  • Hodgkin Disease and Lymphoma, non-Hodgkin
  • leukemia, myeloid, acute
  • leukemia, lymphocytic, acute
  • leukemia, myeloid, chronic
  • leukemia, lymphocytic, chronic
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Carcinoma, Renal Cell
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms



Arizona Cancer Center at UMC North Tucson, Arizona  85719
Arizona Cancer Center at UMC North/University Medical Center Tucson, Arizona  85724