Phase II Trial of Pentostatin and Targeted Busulfan

Completed · Phase 2

Conditions studied: Hematologic Malignancies

In brief

The objective of this trial is to determine whether a regimen of pentostatin and busulfan (IV) can facilitate engraftment of human leukocyte antigen (HLA) partially compatible siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression among 41 transplant patients meeting the inclusion criteria.

Key facts

Study ID

NCT00496340

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

42

Starts

2007-07-01

Expected to finish

2013-08-01

Last updated by the study team

2014-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipients:
• Age: greater than 18 years of age, or younger with parental consent.
• HLA A, B, C, DRB1, DQB1, 10/10 or 9/10 allele sequence matched related donor or unrelated donor available
• Histologically confirmed diagnosis by pathologic review.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1, or Karnofsky performance status of greater than 70
• Organ function:
• Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) >/= 50%
• Cardiac: left ventricular ejection fraction >/= 50%
• Renal: creatinine clearance (measured or calculated) equal or greater than 50 ml/min (at any time pentostatin is administered)
• Hepatic: total bilirubin less than or equal to 2mg/dL, (Gilbert and other syndromes with increased indirect bilirubin should be allowed); serum transaminases less than two times the institutional upper limit of normal (< 2 x ULN).
• Donors:
• Capable of receiving Granulocyte Colony-Stimulating Factor (G-CSF) and undergo apheresis
• Age >18
• Signed informed consent form in accordance with institutional or National Donor Marrow Program (NMDP) policies

You may not qualify if…

• Recipients:
• Pregnant or lactating women
• HIV or seropositive, confirmed by nucleic acid test (NAT)
• Active central nervous system (CNS) malignancy
• Active infection
• Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care.
• Current use of metronidazole or acetaminophen; patients must discontinue use of these agents at least 7 days prior to the start of Busulfex administration
• Prior allogeneic HCT (patients who had received a prior autologous HCT will be allowed)
• Lack of a capable caregiver.
• Presence of any of the following comorbid conditions
• History of recent myocardial infarction within 30 days
• Congestive heart failure (NY class III, IV or if symptomatically uncontrolled)
• Peripheral vascular disease (including intermittent claudication or history of bypass for arterial insufficiency)
• Untreated thoracic or abdominal aneurysm (6 cm or more)
• History of any cerebrovascular accident including transient ischemic attacks within 30 days
• Dementia
• History of recent gastrointestinal bleeding (within 30 days)
• Connective tissue/rheumatologic disorders
• Hemiplegia/paraplegia
• History of solid tumor excluding skin or cervical carcinoma after curative resection. Patients with other prior solid tumor (s) who are in remission for more than 5 years will be allowed on a case-by-case basis
• Donors:
• Pregnant or lactating women
• HIV seropositive, confirmed by NAT
• Human T- lymphotropic virus (HTLV) I/II seropositive
• Hepatitis B or C seropositive

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.